Ashutos Swain - Academic Profile at HigherEdSpace.com

Professional Profile for Ashutos Swain

HigherEdSpace Profile

Ashutos Swain

Basics

Name:
Ashutos Swain
Location:
California, United States
Area of Interest:
Not Specified
(School) Network:
Not Specified
HigherEdSpace Profile:
http://www.higheredspace.com/profile/81913940

Interests

computer system validation	HIPAA electronic security regulations
21 CFR Part 11	FDA regulation
trade compliance	Harmonized Tariff Schedule
/index.php/myinterest/network/tagid/4173	Japan Nuclear Crisis Exposes
Risk management	Risk Management Challenges
Risk Management	Internal Control
financial reporting	ERM program
COSO ERM Integrated Framework	Drug Development in India
drug development projects	clinical trial projects
regulatory audits of clinical sites	Clinical Development in India
Clinical Trials in India	Legal Compliance
Revenue Program	Durable Medical Equipment
DME Revenue Program	HIPAA Security Rule
PCI DSS	Patient Information Protection
health information	payment information
security breach	Accounting of Disclosures
HIPAA rule	eRecords Disclosures
Designated Record Set	Access Reports
HIPAA Security audit	list of disclosures
Business Associate impacts	HIPAA Security compliance
Reliability Engineering for Medical Devices	Reliability tests for Medical Devices
Design FMEA	System FMEA
Component FMEA	Process FMEA
Fault Tree Analysis	Product robustness
medical device	Medical Device CAPA
CAPA Implementation	Device Manufacturing
Root Cause Analysis	CAPA Q&A
CAPA Implementation	Medical Device Setting
Postmarket Surveillance	Section 522
FDA Draft Guidance	Medical Device Industry
PMS 522	premarket approval application
PMA approval	humanitarian device exemption
HDE approval	product
Medical Device Recalls	Maintenance Related Recalls
Maintenance Issues	Maintenance Risks
Reliability Centered Maintenance	RCM
FMEA	Condition monitoring maintenance
Internal health monitoring	EU Medical Device Directives
EU MDD	2010 EU MDD Changes
EU CTD	CE Marking
ISO Certification	EU MDD implementation
Conformity Assessment	Medical Device Technical File
AIMDD	IVMDD requirements
Latin America Regulatory Compliance Requirements	Current Regulatory Climate in Latin America
regulatory compliance requirements and procedures for Pharmaceuticals	Medical Devices
EUCTD Compliance	EU Clinical Trial Directive Compliance Webinar
Training for Medical Device Compliance	Directives for Medical Devices
Compliance Training on Medical Device Directives	Changes to HIPAA Regulations
New HIPAA Privacy and Security Regulations	Interim Final Rules
IFRs	NPRMs
HIPAA	risk assessment
risk analysis	HITECH
PCI	DSS
Security Rule	Breach Notification
meaningful use	regulatory enforcement
willful neglect	security audit
compliance	HIPAA Security Policies
HIPAA Security Procedures	HIPAA
risk assessment	risk analysis
HITECH	PCI
DSS	Security Rule
Breach Notification	Business Associate
510(k) Submission	Recent Changes in the 510(k) Program
510(k) premarket notification	510(k) submission format
21 CFR 807.92(a)(3)	510(k) actions and improvements
Medical Device Software Validation	QMS software requirements
21 CFR 820.70(i) requirements	Part 11 compliance
Excel data validation	validation protocols
Medical Device Sterilization	Application of CAPA in Sterilization
EO Sterilization	Radiation Sterilization
Sterilization basics	corrective action
CAPA	sterilization process
sterilization	Medical device process validation
process validation compliance	process validation statistical considerations
statistical considerations	FDA medical device process validation regulations
Design History Files	Device Master Records
Device History Records	Technical Files
Design Dossiers	FDA Requirements
DHFs	DMRs
Medical device master record implementation	medical device history record implementation
DHR implementation	DMR implementation
medical device records requirements	Letter of Response
OSHA Complaint	OSHA Inspection Guidelines
Accident Investigations	OSHA Inspections
OSHA Subpart Z Regulations	IH Regulations
Subpart Z	Toxic and Hazardous Substances
Expanded health standards	Industrial Hygiene Regulations
OSHAâ€™s subpart T	pre-engineering survey
Environmental Assessment	OSHA Requirements
Pre-Demolition Engineering Survey	OSHA Inspections
Accident Investigations	OSHA Inspection Guidelines
OSHA Complaint	Letter of Response
Surprise OSHA Inspections	OSHA Citation
SHA Regulations on Asbestos	OSHA Guidelines for Mold
OSHA Asbestos and Mold Regulations	OSHA awareness training
Asbestos awareness training	medical device supplier
medical device supplier evaluation	medical device quality requirements
Supplier Evaluation and assessment	U.S. Medical Device Regulations
EU Medical Device Regulations	Canadian Medical Device Regulations
global device compliance	global device regulatory process
customer complaint FDA regulations	customer feedback management
handling customer complaints	Customer complaints
Design Control	Medical Device Design Control
Design Control Requirements	Documentation Requirements
Design Control Process	Design Documentation
CLIA compliance training webinar	CLIA compliance
Clinical Laboratories Improvement Act	CLIA inspection
preparing for CLIA inspection	CLIA inspection follow up
CLIA compliance training	CLIA Waived Testing
Waived testing rules	CLIA Waived Testing regulations
CLIA Waived methods	Waived Testing Application
CLIA Waived Testing pitfalls	ISO 14971 Risk Reduction
Root Causes Analysis	Advanced Methods of RCA
FDA requirements for RCA	FDA QS requirements
FMEA	Root Causes Analysis Methods
FDA regulatory compliance training	EU MDD regulations compliance
Project management compliance	FDA project management regulations
FDA compliance training	Medical Device Quality
Device Efficacy Requirements	Medical Device Efficiency Requirements
Quality Assurance Practices	FDA Quality System Requirements
OSHA Recordkeeping	Recordkeeping Interpretations
Handling OSHA inspections	limiting OSHA investigations scope
OSHA inspection scope	avoiding self incrimination during OSHA inspections
OSHA inspection procedures	California Environmental Regulations
U.S. EPA	State EPA Requirements
California EPA requirements	Proposition 65
California Hazardous Waste Control Law	California OSHA
Enforcement	Federal
compliance	trainingOSHA versus federal OSHA
inspections	federal citation appeals process
Microbial Control	Pharmaceutical Water Systems
sampling	testing
sanitization	troubleshoot problems
FDA	control myths
microbial enumeration	EO Validation
Validation processes	CAPA
EO sterilization processes	FDA
medical device sterilization	Medical OEM Molding Operation
Validated Systems and Processes	equipment
molds	dies
systems	Master Validation Plan
Quality Plan	Risk management
quality procedures	Adverse Event Reporting
Medical Devices	Clinical Trials
Post-Marketing	medical device surveillance
vigilance system	CAC information
21 CFR Part 820	ISO 13485
Medical Device 510K Submission	510K process
PMA	510k versus PMA
Class I devices	Class II devices
civil seizure lawsuit	Sterilization compliance training
sterility failure investigations	bioburden test failures
bioburden test failures RCA	sterility test failures root cause analysis
RCA	root cause analysis
Medical Device Quality System	FDA requirements
21 CFR Part 820	QSR
Quality System Regulation	FDA QSR
Design Controls	Document Controls
Purchasing Controls	Bioanalytical Methods Validation
Bioanalytical Procedures	FDA Guidance
EMA Guidance	phased approach
Ligand-binding Assays	Microbiological Assays
GLP Records	Archiving Practices
Laboratory Records	on-site review
archive structure	archive facility
in-house archiving	out-sourced archiving
Laboratory investigations	Laboratory Excursions
Laboratory Deviations	ICH Q7A
Laboratory Excursion Investigation	21 CFR 210
21 CFR 211	investigational tools
pharmaceutical procedures	Laboratory Control System
Quality Control Laboratory	FDA Inspections
System Based Inspections	OOS results lab processes
laboratory investigations	laboratory compliance training
OOS compliance training	Out of Specification results compliance training
tracking of accesses	accounting of disclosures
Electronic Health Records	New FDA Regulations
EHR Compliance	HIPAA Compliance
Medical Devices	Risk Management
ISO 14971	Hazard Assessment
FMEA	FTA
Device Risk Analysis	risk evaluation matrix
/index.php/myinterest/network/tagid/5264	Medical Devices
Risk-Benefit Decisions	Medical Device Lifecycle
ISO 14971	FDA Approval
Clearance Process	risk/benefit decisions
device safety	pivotal studies
Acceptance Activities	FDA QSR
Warning Letters	Quality Management System
acceptance criteria	acceptance records
record keeping	medical device manufacturing
Equipment Calibration	FDA QSR
Warning Letters	ISO 13485
ISO 9001	medical device manufacturing
Supplier Controls	U.S. FDA Requirements
Supplier Ranking Models	CGMP compliance
supplier management	supplier audit
Device Corrections and Removals	FDA QSR Part 806
FDA QSIT	reporting problems
Part 803	Part 1004
Regulatory requirements	method validation
FDA	ICH
Documenting test	Good Laboratory Practice
21 CFR Part 58	Testing Facility Operations
General Equipment	Laboratory Notebooks
Standard Operating Procedures	Bio-analytical Testing Laboratory
Clinical Research	510(k)
Regulatory Requirements	Quality System Regulations
PMA	Pre Market Approval Submission
Medical Device Submissions	FDA medical device forms
FDA requirements	OOS Investigations
CAPAs	Equipment Qualification
Biologics Stability Programs	ICH
WHO	Stability methods
GMP systems	Pharma GMP system
Biotech GMP system	Medical Device Regulation
FDA Regulations	510(k) Premarket Notification
Premarket Approval	Labeling and Promotion
QSR	Quality System Regulation
21 CFR Part 820	medical device imports
Patient Monitoring Devices	Alarm Standards
Alarm Safety	FDA recalls
alarm effectiveness	Class I medical device
design techniques	alarm response
risk analysis	acceptance sampling
variables data	attributes data
Z1.9 system	Z1.9 methods
known variability	unknown variability
range method	standard deviation method
liquid chromatography	Orthogonality
Multidimensionality	method development
analytical chemistry	chromatography
HPLC	Equipment calibration compliance training
equipment qualification training	FDA laboratory regulations
FDA laboratory guidelines	FDA regulations compliance training
CLIA regulations compliance training	Clinical Laboratory Improvement Amendments compliance
CLIA standards training	CLIA calibration verification standards
HHS compliance	OIG compliance
Laboratory compliance	Medicaid Guidelines
Medicare Guidelines	Lab Compliance Plan
Lab Compliance	CLIA compliance
CLIA regulated non-waived laboratories	CLIA regulated laboratories
QC plan	Quality Control plan
ISO 17025 compliance training	good laboratory practices compliance training
ISO training	quality system compliance
ISO laboratory standards	laboratory quality systems
510k review process	510(k) guidance documents
Medical Device	FDA 510k compliance
FDA regulations	Medical Device Reporting
Medical Device Software	Software V&V
Verification	Validation
FDA requirements	Verification Methods
Manufacturers	Medical Device
Risk Assessment	Risk Mitigation
New Global Engagement Initiative	GMP Compliance
Code of Federal Regulations	21 CFR Part 111 Training
FDA guidance enforcement	FDA global enforcement
acceptance sampling	variables data
attributes data	Z1.9 system
Z1.9 methods standard deviation method	CE Marking
good laboratory practices compliance training	ISO 17025 compliance training
Compendial Methods	Verification
USP Chapter 1226	21 CFR 211 194 Training
quantitation	specificity
PPACA 2010 compliance	OIG enforcement
Quality Assessment plan	HIPAA Breach Notification
Breach Notification Policy	HIPAA risk analysis
EHR funding	HIPAA Challenges
Patient Communications	Smart Phones
Portable Devices	Social Media
risk assessment	OSHA update
Hazard Communication Standard	categories of hazards
workplace hazards	control of hazardous energy
lockout procedure	demolition risks
Surprise OSHA Inspections	FDA 510k program
medical device requirements	medical device regulations
FDA approval	FDA submission
Risk Management	Quality Management System
EU medical device directive seminar	Medical device manufacturers CAPA system
FDA QSR CAPA requirements	FDA quality system regulations
Radiation Process and Validation	Critical and noncritical deficiencies
clinical evaluation	FDA guidance document
tagout procedure	OSHA Recordkeeping
Common Misconceptions	Common Misunderstandings
Recordkeeping Rules	OSHA Interpretation
OSHA 300 Logs	drug studies
GLP	good laboratory practices
GLP drug studies	Test Article Characterization
FDA bioanalytical laboratories guidance	Good Laboratory practices compliance
bioanalytical labs GLP	Bioanalytical laboratories GLP
GLP Study	non-GLP facility
GLP activities separation	new drug development
safety testing	recordkeeping compliance
regulated studies	Scientific Misconduct
Regulated Studies	questionable data
ethical standards	FDA compliance training webinar
FDA CAPA inspection preparation	FDA CAPA guidance for inspectors
FDA regulations	FDA CAPA
CAPA compliance	QSIT manual training
cGMPs	medical devices
in vitro diagnostic devices	IVDs
quality system regulations	medical device QSRs
quality system regulation	ISO 13485 requirements
Process Safety Management	National Emphasis Program
compliance guidelines	FDA bioanalytical labs regulations
drug test article characterization	Quality Control Laboratory
Laboratory Control System	Reusable Medical Devices
Cleaning Validation	FDA Requirements
Instruction for Use	Cleaning Processes
regulatory compliance requirements and procedures for Pharmaceuticals	Current Regulatory Climate in Latin America
Latin America Regulatory Compliance Requirements	FDA medical device QSR
FDA Quality System Regulation for medical devices	FDA Expectations for Root Cause Analysis
FDA Compliant CAPA	Risk Based Verification and Validation
FDA GMP Requirements	ICH Q9
ISO 14971 Requirements	Master Validation Plan
V&V planning	V&V protocols
EU Medical Device Directives	EU MDD
2010 EU MDD Changes	EU CTD
CE Marking	ISO Certification
EU MDD implementation	510(k) submission process
FDA compliance training	510(k) compliance training
510(k) regulatory requirements	Manufacturing medical products
GMP	Good Manufacturing Practices
Setting Environmental Monitoring Alerts	environmental monitoring excursion limits
bioburden test failures RCA	bioburden test failures
sterility failure investigations	Sterilization compliance training
OTC Drug Products	FDA Regulation
Over-the-Counter Drug Products	marketing OTC products
Rx to OTC Switch	OTC Monograph
Rx Drug	OTC product labeling
pharmaceutical GMPs	Quality Control Regulations
GMPs	Pharma Quality System
Quality Assurance	ICH Q10
Dietary Supplements	Regulatory Compliance
Labeling Issues	dietary supplement regulations
FDA Updates	blood borne pathogens
OSHA safety program	blood borne pathogen standard
OSHA requirements	occupational exposure
protective methods	employee training requirements
OSHA Safety Investigations	OSHA Accident Investigations
Near Accident Investigations	Workplace Accident Investigations
Investigation Protocols	Machine Guarding
hazardous energy	OSHA compliance
LOTO program	types of machine guards
blanking and blinding	double-block and bleed
line breaking	OSHA Compliance. OSHA Interpretations
Hazardous Energy	energized equipment
de-energized equipment	OSHA compliance guidelines
OSHA letters of interpretation	Biosimilars
FDA Regulation	draft guidance documents
biologic products	reference product
Lyophilized Products	Container Closure Systems
closure system integrity	Vial types
vial formulations	vial leachables
vial extrcatables	Biosimilar Analytics
Biosimilar Characterization	Comparability Testing
Biosimilar guidances	Biotech Training
GCP Requirements	CAC Requirements
Integrative Compliance	ICH-GCP guidelines
regulatory compliance	Clinical Compliance
clinical trials	medical device trials
21 CFR Part 11	predicate rules
risk mitigation	ComplianceOnline Training
Medical device Training	FMEA
risk management	Design History Files
Medical Devices Training	FDA requirements
DHF compliance	Gap Analysis
Traceability matrix	Design Controls
Medical Devices	FDA Requirements
Design Review	Design Verification
Design Validation	Design Transfer
QSR requirements	regulatory requirements
dimensions of competency	Medical device training
Regulatory Compliance	Ethylene Oxide Sterilization
Medical Device Sterilization	Pharmaceutical Training
laboratory water systems	lab water quality
water system validation	water system design
FDA 483s	Pharma Training
Citizen Petitions	Suitability Petitions
Supporting Documents	Drafting Petitions
FDA Regulations	Guidance Documents
FDA petition process	Impurities in Pharmaceutical Products
General Impurities	Residual Solvents
guidance documentsDegradation products	disinfectant qualification
cleanroom disinfection	types of disinfectants
microbial contamination control	aseptic processing environments
cleaning procedures	Pharma Training
regulatory landscape	FDA guidances
drug development	biomarker qualification
biochemical biomarker	genomic biomarker
imaging biomarkers	Pharmaceutical Water System
water system control	biofilm contamination
Chemical testing	Endotoxin testing
Microbial testing	microbial sampling techniques
Laboratory Compliance	Bioanalytical Methods Validation
CLSI Guideline EP-23-A	Laboratory QC
Quality Control	laboratory investigations
laboratory compliance training	OOS compliance training
compliance training	GLP compliance
noise monitoring strategy	industrial hygiene
OSHA compliance	Global Medical Device regulations seminar
Global medical device regulations training	US medical device regulations
EU medical device regulation	ComplianceOnline Training
Medical device Training	Test Equipment V&V Files / Protocols
China life science product regulations	Pacific Rim life science product regulations
China pharmaceutical regulation	China medical device regulation
Laboratory Inspections seminar	Laboratory inspections workshop
Good Laboratory Practices	GLP seminar
FDA Laboratory inspections	FDA inspections
Pharmaceutical Seminar	IND submission seminar
orphan drug development	IND application
drug development seminar	FDA pharmaceutical regulations
FDA drug regulations	FDA Regulation
Clinical Compliance	EO sterilization compliance
medical device manufacturing compliance	medical device regulations
Medical Device Risks	Risk Management Process
Risk Analysis	Risk Evaluation
Risk Control	EU market
Medical Device webinar	medical device CAPA
Corrective and Preventive Actions	FDA CAPA requirements
quality tools	process verification
process validation	post market surveillance
medical device regulations	risk management
ISO 14971	clinical evaluation
Method Validation	Guidance Documents
Lifecycle Approach	QbD Approach
Pharmaceutical Analytical Methods	GMP requirements
raw materials	warning letters
raw material management	GMP regulations
risk management	vendor selection
validation	FDA inspection
quality control	Method Validation
Analytical Procedures	Common Deficiencies
Acceptance criteria	Drug Products
ICH Validation Requirements	FDA Validation Requirements
Re-Validation plan	contamination control training
contamination prevention	preventing microbial contamination
CAPA procedures compliance	corrective actions
preventive actions	microbiology lab
clinical trials	IDE Studies
investigational devices	IND Studies
investigational drugs	IDE vs. IND
Clinical research	Quality Assurance
QA programs	site monitoring
clinical site audit	serious adverse events
anticipated events	unanticipated events
unanticipated problems	UCH guidelines
GCP guidelines	FDA guidance
Investigator Initiated Trials	Investigator Sponsored Trials
ISS	recent legislation
revised guidance documents	anti-kickback statutes
GCP guidelines	ICH guidelines
clinical trials team	clinical monitor assistant
Clinical trials	open source technology
electronic data capture	clinical research
system validation	IRB guidelines
reportable event	institutional deviation policies
DHHS guidance	ICH guidelines
Clinical Studies	Clinical Deviations
OSHA requirements	workplace egress
fire protection systems	International Building Code
dosimeters	OSHA compliance
industrial hygiene	chemical inventory lists
safety data sheets	health hazard evaluation
sampling methods	analytical methods
29 CFR Part 1910.1200	OSHA refresher training
shock hazards	blast hazards
protective clothing	arc flash hazards
electrical safety compliance	safety metrics
safety performance	types of safety metrics
recordable rate	severity rate
leading indicators	trailing indicators
incident rates	performance measurement
clinical trial needs	clinical research organization
CRO contract negotiation	CRO selection
Sponsor CRO relationship	Clinical Trials
NCD	National Coverage Decision
CTP	Clinical Trial Policy
MCA	Medicare Coverage Analysis
clinical trial billing	ComplianceOnline Training
CDISC	Clinical Data Interchange Standards Consortium
Regulatory Submissions	verification
Method Validation	Method Qualification
Analytical Methods	Biotech Training
co-validation	Standards Q2R1
Documentation	biologics
Vaccine Registration	WHO Requirements
Stability Studies	Vaccine Products
vaccine stability study	Biotech Training
HIPAA Audit Protocol	HIPAA Audit Process
HIPAA policies	HITECH Act
ARRA 2009	HHS OCR
HIPAA compliance	HIPAA Privacy
HIPAA Security Rules	breach notification
Breach Notification	risk analysis
Social Media	risk assessment
Portable Devices	Smart Phones
HIPAA Privacy	HIPAA compliance
interim final rules	HITECH Act
HIPAA policies	HITECH amendments
Laboratory Investigation compliance training	non-clinical trial compliance
clinical trial compliance regulations	sample reanalysis training
sample reanalysis compliance	lab investigations
Laboratory Risk Management	laboratory data
data integrity	data security
FDA/EU Requirements	electronic data
data acquisition	data archiving
OSHA inspection	inspection process
OSHA records	safety documents
OSHA citations	OSHA fines
inspection plan	types of OSHA inspections
OSHA compliance	OSHA NEP
National Emphasis Program	Anhydrous Ammonia Refrigeration
Process Safety Management	chemical plant refrigeration
OSHA interpretations	compliance guidelines
PSM regulation	Phase 1 investigational drugs
Phase 1 drugs compliance	Phase 1 IND studies
Phase 1 IND regulations	current good manufacturing practices
FDA Phase 1 IND regulations	FDA pharmaceutical regulations
cleanroom procedures	clean room contamination
Pharmaceutical Training	clean room environment
cleanroom technology	excusrion events
IND Applications	Phase I Studies
IND regulations	IND Sections
FIM Clinical Trials	clinical development plan
clinical procedures	IND submission strategy
regulatory submission	analytical development
pharmaceutical training	ICH Q3 A/B Requirements
Pharmaceutical Products	water system design compliance training
good laboratory practices	water system contamination
microbial monitoring training	microbial control training
microbial test methods	microbial enumeration
FDA requirements for DHF	Design Control Audit
QSR 21 CFR Part 820	Design History File
Medical Devices Training	Medical OEM molding
contract manufacturing	equipment transfer
molding operation	system validation
process validation	gap analysis
validation plan	Design History Files
Device Master Records	Device History Records
Technical Files	Design Dossiers
FDA Requirements	OSHA Hazard Communication standard
Global Harmonized System requirements	Chemical Classification requirements
OSHA Hazard Communication compliance	OSHA compliance
OSHA recordkeeping seminar	OSHA recordkeeping training
OSHA recordkeeping compliance	OSHA regulations
OSHA Hazard Communication standard	Global Harmonized System requirement
OSHA recordkeeping seminar	OSHA recordkeeping training
OSHA recordkeeping compliance	OSHA regulations
Latin America medical device regulations	Latin America pharmaceutical regulations
Latam life sciences regulatory requirements	Latin America life sciences regulations
Latin America regulations	Contamination-Control
Cleaning and Disinfection	manufacturing
Dietary Supplements	FTC Regulations
FDA Regulations	Medical device Seminar
Medical OEM Molding	Risk management
small molecule products	Biotech Training
basics of freeze drying	lyophilization process
lyophilization procedure	primary drying
secondary drying	optimal formulation development
lyophilization cycle design	Biotech Training
biotechnology analytical methods	FDA audit of biotechnology analytical labs
quality compliance for biotechnology analytical labs	analytical techniques in biotechnology
GCP non-compliance	investigator site non-compliance
filing efficacy study data	sponsor regulatory application
GCP noncompliance observations	GCP compliance objectives
sponsor risk management	Clinical Compliance Webinar
risk-based monitoring for clinical trials	FDA guidance on risk-based monitoring
ICH/GCP requirements	clinical trial quality
clinical trial monitoring	CMA roles
CMA responsibilities	Good clinical practices compliance
FDA GCP requirements	FDA GCP inspections
quality improvement methods	clinical trial compliance
clinical research compliance	clinical trial regulations
Quality in Clinical Research	Quality Systems in Clinical Trials
Quality Systems Training	QSR in clinical research
Clinical Trial Risk Management	applying CAPA in clinical research
human subjects research	human subjects protocol
research protocol	research study
study submission to IRB	IRB review
IRB study approval	Institutional Review Board approval
human subjects	non-inferiority trials
NI trials	equivalence
superiority trials	superiority study objectives
clinical study design	hypothesis tests
statistical interpretation	Clinical Quality Management System
risk-based monitoring in clinical research	Quality Systems in Clinical Research
clinical monitoring requirements	FDA risk-based monitoring guideline
investigator site non compliance	GCP regulatory compliance
clinical investigator GCP noncompliance	clinical investigator liability
FDA GCP noncompliance observations	GCP noncompliance risks
Clinical Standardization	implementing clinical data standards
Common misconceptions about clinical data standards	Clinical Data Interchange Standards Consortium
CDISC	clinical data interchange
clinical trial methodology	clinical trial best practices
clinical trial procedures training	GCP compliance
Quality Management in Clinical Trials	regulatory expectations for informed consent
voluntary informed consent	sponsor roles and responsibilities
investigator roles and responsibilities	ethics committee roles and responsibilities
clinical data quality	ensuring data quality in clinical audit
clinical data quality management	data quality in clinical trials
data handling in clinical trials	data use in clinical trials
FDA Regulation	microbiology lab audit
FDA quality compliance audit	microbiological laboratory failure modes
microbiology lab audit planning	lab audit guidance
sterility testing	FDA requirements for training
Training Practices for FDA Compliance	Training for GMP Compliance
Training for GxP	21 CFR Part 11
Computer Validation training	FDA and Cloud Computing
cloud computing compliance	FDA validation and cloud computing
cloud concepts	cloud computing terminology
cloud computing in regulated environments	Computer Systems Validation Training
Project Management for CSV	FDA regulations for computer systems
21 CFR 11 Compliance training	project management for 21 CFR Part 11 compliance
21 CFR Part 11 training	21 CFR Part 11 requirements
21 CFR Part 11 compliance	Importing Electronic Signatures
Importing Electronic Records	fda compliant records management
record integrity	records management policy
record retention schedule	records management regulatory compliance
records audit procedure	maintaining record validity
Medical Device Webinar	risk-based supplier control
supplier risk management	Control of outsourced processes
supplier audits	GHTF
FDA requirements for supplier control	types of non-clinical study
non-clinical studies for implantable medical devices	non-clinical studies for interventional medical devices
non-clinical study project	Refuse to Accept Policy
Premarket Notification	510(k) approach
medical device submissions	MDUFA
Acceptance Review	Substantive Review
510k submission process	510(k) guidance documents
K97-1 Memo	Substantial Equivalence
510k review process	successful 510k submissions
510k submission elements	filing 510k
FDA 510k requirements	/index.php/myinterest/network/tagid/7225
compliant handling warning letters	inadequate compliant handling
compliant handling and reporting	compliant handling pitfalls
Medical device recalls	FDA regulations for biomaterials supplier
biomaterials for medical devices	specialty chemicals
Supplier Liability	Biomaterials supplier liability
supplier risk	Device supplier risk
medical device recalls	recall process
regulatory enforcement	FDA regulations
health hazard evaluation process	FDA 510(k) Submission
Premarket Notification	Premarket Approval
PMA	Quality System
medical device marketing	CDRH
medical device labeling	identifying a predicate device
substantial equivalence	Medical device regulatory requirements
medical device process validation	FDA inspections
medical device FDA regulations	medical device FDA audits
FDA site inspections	FDA process audits
Quality Assurance Agreements	supplier QA agreements
risk-based supplier control	supplier risk management
control of outsourced processes	supplier audits
GHTF	FDA requirements
BLA registration	Forced Degradation Studies
Biologics Stability Programs for Biopharmaceuticals	Pharmaceutical Webinar
managing intellectual property records	IP records
patent filing for pharmaceutical products	requirements for research records
filing patent applications	Pharmaceutical training
Thermal cycling study.	pharmaceutical manufacturing
personnel practices	microbial control
gowning	cleanroom operations
contamination control	cleanroom cleaning
process equipment	product contact surfaces
FDA	EMA
Pharmacogenomics regulation	FDA regulation of Pharmacogenomics
applications of pharmacogenomics	challenges in pharmacogenomics
pharmacogenomics and patient safety	pharmacogenomics data
Quality risk management	pharmaceutical quality
ICH Q9	ISO 14971
patient safety	regulatory inspections
risk management tools	Record validity
record security	record retention
document retention	regulatory requirements
electronic records	media options
software formats	long term archiving
FDA guidance on OOT test results	FDA requirements for Out-of-Trend Results
Out-of-trend results investigation	Out-of-specification results investigation
OOT evaluation	OOT evaluation
new FDA requirements for food safety compliance	food safety compliance
FSMA requirements	Food Safety Modernization Act
Hazard Analysis and Critical Control Points	HACCP compliance
Product specification for food safety	food safety
product physical characteristics	quality control points
validating chemical tolerance	product physical micro tolerance
product specification	Food manufacturing sanitation
food manufacturing safety	HACCP
GFSI audits	plant cleaning
chemical safety basics	MSDS for emergencies
storage of chemicals	HACCP and food safety
GLP for food labs	GLP in food manufacturing
requirements for food testing labs	food lab accreditation
Food Allergen Labeling	FDA
FALCPA 2004	Food Allergen Labeling and Consumer Protection Act
FALCPA requirements	FSMA
Food Safety Modernization Act	Food allergens compliance
Qc laboratory data	FDA documentation practice
laboratory data management	laboratory analysis data management
good documentation practices	fda documentation requirement
computerized documentation	pharma laboratory efficiency
pharmaceutical laboratory productivity	laboratory personnel hiring
laboratory staff motivation	Computerized laboratory systems
chromatography	LIMS
Transfer of Analytical Procedures	USP Chapter 1224
Method Transfer in Laboratories	USP and FDA requirements
transfer plan	method transfer protocol
Lab inspection types	pre-approval inspection
gmp inspection	lab training SOPs
lab maintenance SOPs	Lab training and maintenance SOPs
lab OOS result	FDA Laboratory regulations compliance
FDA OOS guidance	safety committee
OSHA compliance	safety plan
safety committee guidelines	safety committee goals
safety committee purpose	state safety laws
federal OSHA requirement	respirator protection program template
OSHA compliant respiratory program	types of respirators
respirator protection program	29 CFR 1910.134 Regulations
High Voltage Safety	Workplace Electrical Safety
utility type electrical safety	OSHA Electrical Safety
National Electric Safety Code	NESC Standards
NFPA Standards	electrical safety work practice
Posting of OSHA citation	Informal Conference
Occupational Safety & Health Review Board	OSHA appeal
abatement period	requesting informal conference
OSHA investigating documents	OSHA fines
Food Compliance	medical device complaint handling
medical device complaint management	medical device reporting
medical device regulations seminar	medical device recalls seminar
Emerging market life science regulations seminar	Brazil life science product regulations
Russia life science product regulations	India life science product regulations
China life science product	FDA training seminar
FTC advertising seminar	advertising drugs
advertising medical devices	promotion drugs
promoting medical devices	FTC advertising rules
FDA marketing rules	ICH Quality Guidelines seminar
Statistical Considerations seminar	ICH guidelines
pharmaceutical manufacture	biotech manufacture
statistical methods	ICH guidelines compliance
statistical methods	Food marketing seminar
compliant food marketing claims	food marketing enforcement actions
food marketing claims risks	food marketing claims lawsuits
food marketing regulations	enforcement action
ISO 14971	ISO TR 24971
application of ISO 14971	medical device risk management best practices
effective device risk management	medical device risk management policy
Risk management planning	Pharmaceutical regulatory training
drug regulations training	FDA drug guidance
FDA drug seminar	pharmaceutical seminars
drug master file training	drug master file
DMF preparation	DMF guidance
/index.php/myinterest/network/tagid/7771	mobile applications
mobile medical applications	device software
medical device software	software interoperability
software validation	software risk assessment
MDDS	medical device data system
Clinical Trials	medical device regulations seminar
medical device compliance training	FDA medical device regulations
FDA Form 482	Form 483
Form 484	Unique Device Identification rule
UDI rule	Statistical Analysis
product development	statistical methods
variability	design of experiments
systematic variability	special cause variability
analytical method development	process improvemen
Warning letters	fda inspection
Seizures	Injunctions and Prosecutions
risk based inspection	inspection dos and donâ€™t
fda internal audit	fda compliance monitoring
fda inspection response	10-step risk-based validation approach
21 CFR Part 11 Compliance	Annex 11 Compliance
Avoid 483s	Biotech Training
Immunogenicity Testing	antibody response against therapeutic proteins
EMEA guidance on immunogenicity	immunoassay
Regulation of ATMPs in Europe	role of the Committee of Advanced Therapy
regulatory requirements for ATMPS in EU	CMC requirements for ATMPs
classification procedures for ATMPS	Clinical studies for
cGMP regulatory requirements training	cGMP compliance training
FDA compliance training	FDA biologics regulations
EMEA Regulations training	Well Characterized Protein Products
FDA BLA Sponsors Requirements	BLA Sponsors
FDA Biological Compliance	Biological Products
Proteinaceous Particulates	deviation reporting
patient-reported outcome (PRO)	Statistical Considerations
SAPs	Electronic Data Capture (EDC)
Multiple and Composite Endpoints	Protocol Considerations
PRO-based claims	PRO instrument
PRO data	Clinical Trial Contract
contract negotiation process	clinical research contracts
federally complaint contracts	the Stark Rule
Antikickback Statute (AKS)	False Claims Act (FCA)
Randomized Control Trials	Design of Non-inferiority Trials
Design of Equivalence Trials	clinical trial design
developing clinical questions	FDA guidances for NI trials
CONSORT	Clinical supply planning
Cost optimization	Site demand uncertainty
Supply risk management	Risk of stock-out
Manufacturing schedule	clinical supply chain costs
clinical trial inventory levels	FDA Product Complaint Investigations
Lean Six Sigma methodology	investigating product complaints
FDA CAPA	Process Improvement
FDA quality systems	CAPA for lifescience products
Scope of FDAâ€™s Inspection Authority	FDA's Access of Company Records
preparing for an FDA inspection	FDA inspection limits
FDA's 1997 guidance on 510(K)	Modifications to a Cleared Device
21 CFR 807.81(a)(3)	design change control
21 CFR 820.30	filing a new 510(k)
510(k) evaluation process	Canadian Medical Device License
Canadian Device Classification	Canadian licensing submission
Summary Technical Document	STED Requirements
requests for additional information	Canadian regulatory
FDA Quality Audits	FDA QSIT Sampling Plans
Quality System Inspection Technique	FDA QSR
sampling of records	nonconformance of records
Pharmaceutical webinar	eDiscovery risk
eDiscovery practices	records management concepts
patent infringement	trademark infringement
information retention	litigation hold
environmental monitoring	laboratory clean room
Pharmaceutical webinar	FDA quality system requirements
EMEA quality system requirements	GMP quality system requirements
pharmaceutical GMPs	pharmaceutical quality system
biopharmaceutical GMPs	Pharmaceutical webinar
pharmaceutical manufacturing	Biopharmaceutical Manufacturing Systems
29 CFR 1917.116 requirements.	effective field safety program
elevator industry hazards	OSHA elevator safety regulations
Elevator Field Safety Program	"Food recall response training
FDA food recall rules	crisis response plan
food recall planning training	food safety webinar
FDA food safety guidelines	FSMA documentation requirements
HACCP requirements	new FSMA requirements
FDA food safety compliance	FSMA food safety compliance
food allergen	ALLERGENIC SUBSTANCES
food labeling	FDAâ€™s gluten-free requirements
gluten-free declaration	food packaging
HITECH interim rules	proposed rules and HHS Audit Protocols
HITECH act	HITECH policies and procedures
HIPAA hitech rules	EHR Stage 1 and 2 Meaningful Use
HIPAA Security and Privacy Rules	EHR compliance
HIPAA audit	HIPAA Security Rules
patient rights	Electronic Protected Health Information (ePHI)
HIPAA risk analysis	HIPAA security rule
HIPAA hitech rule	HIPAA standards
Patient Communications	HIPAA Challenges
Security Rule	Laboratory Compliance
Testing of Certified Reference Material	Handling Certified Reference Material
Good Laboratory Practices compliance training	CLIA method validation standards
CLIA calibration verification standards	CLIA regulations compliance training
OSHA	OSHA Inspection
violations	reasons for OSHA audit
top violation list	safety program
safety committee	rules and regulations
OSHA penalties	inspection process
Clinical Research Physician	roles and responsibilities of a clinical research physician
key competencies of a clinical research physician	GCP compliance
subject safety	drug efficacy evaluation
OSHA	emergency plan authority
workplace emergency communication	emergency compliance and regulations
emergency management planning	workplace emergency plan
Global Clinical Trials	Avoiding Protocol Deviations
clinical study protocol development	global clinical trial environment
global clinical trial operations	global clinical trial regulations
ICH	Medical Devices
Chinese SFDA regulations for Pharmaceuticals	China Compliance Processes for Life Science Products
FDA regulations	medical device complaint handling
Sterilizing Grade Filter Validation	Process Validation of Membrane Filters
PDA Technical Report #26	2008
2004 FDA Aseptic Processing Guidance	facility design
FDA Compliance	Environmental Monitoring
Contamination Control	Cleanroom cleaning
Process Improvement	FDA quality systems
CAPA for life science products	FDA complaint management process
CAPA investigations	risk assessment tools
CAPA tools	Lean Six Sigma methodology
FDA quality system requirements	EMEA quality system requirements
GMP quality system requirements	pharmaceutical GMPs
pharmaceutical quality system	biopharmaceutical GMPs
FDA training requirements	employee safety training
minimizing human errors and accidents	worker safety
employee safety	workplace safety
workplace accidents caused by human error	reducing workplace injuries and accidents
HIPAA	HITECH
Encryption	HIO
HIE	Office of Civil Rights
Audit	Data Security
Privacy Rule	Notice of Privacy Practices
Security Requirements	ePHI
PHI	patient health information
US Health Care Reform	PPACA implementation
PPACA effect on lifescience companies	Reimbursement Strategy for Devices
Reimbursement Strategy for Diagnostics	Pediatric Coding Top Tips
Pediatric CPT Changes 2013	pediatric medical services
CPT 2013 code	super bill updating
Pediatric Coding guidelines	Electronic Medical Record systems
regulatory requirements for EMRs	electronic communications policies
electronic communications procedures	EMR design
EMR compliance	HIPAA compliance
pathology documentation training	Pathology Reporting in Healthcare
surgical pathology codes	pathology reports audit
surgical pathology report	OSHA safety program
OSHA abatement	OSHA audit training
OSHA audit forms	OSHA audit checklist
OSHA Audit Documents	Federal OSHA Audit
OSHA fall protection requirements	fall protection approaches
preventing fall related injuries	typical fall hazards
fall prevention plan	29 CFR 1910.147
1910.147 regulations	OSHA hazardous energy control
Lockout/Tagout training	LOTO program
LOTO	OSHA 1910.147
workplace energy control	workplace safety
29 CFR 1910.147	LOTO
Lockout/Tagout	1910.147 standards
OSHA hazardous energy control	workplace safety
employee safety	OSHA compliance
Lockout/Tagout of energy	OSHA compliance training
OSHA recordkeeping compliance	OSHA records
OSHA injury recordkeeping	OSHA illness recordkeeping
OSHA 300 Log	recordkeeping errors
OSHA training	EHS metrics training
Safety Metrics	Environmental Health and Safety Metrics
EHS Metrics	Safety Management System
safety metrics program	covered process
Food safety	safe food
safe water	post disaster
disaster plan for food safety	center of disease control
CDC	cleaning
sanitizing	refreezing food
cross contamination prevention	common food allergens
sources of food allergens	Food Allergen Control
Food Allergen Awareness	Microbiological Sampling of Foods
Microbiological Sampling Programs for food products	raw materials sampling
food microbiological methods	FDA
FDA updates	FDA for 2013
food safety compliance	food safety control
retail establishment	procedures
HACCP Programmes	hazard control
2013 food code	Validating cleaning process
may contain claim	absence of allergens
result interpretation	cleaning procedure
Validation vs Verification	Identifying allergens
production process	Food Supplements in EU
Canada	food supplement directive
food supplement authoritative bodies	food supplement ingredient validity
food supplement registration	food supplement labeling
Foreign Material	Foreign Objects
FM	Equipment Control
Sanitation	foreign material control
food processing control	HACCP
acute hazards	SOP
guidance principles	removal system
contractors of services	maintenance plan
selecting equipment	maintenance
control measures	engineering work hygiene
hygiene issues	Food safety
Microbiological sampling	operating characteristics
result interpretation	laboratory analysis
quality assurance	food processors sampling
assurance program	risk assessing contractors
HACCP team	Developing HACCP
HACCP team coordination	Pre- requisites
management of safety	Seven Principles of HACCP
Hazard Analysis	Risk Assessment Techniques
undertake HACCP study	HACCP plan
Food advertising	drug advertising
social media ads for food and drug	social media limitations
regulatory compliance implication FDA requirements	FTC requirements
FDA guidance	cell culture components
cell fermentation process	upstream biologics processes
requirements for cell culture medium	aseptic operation
mathematical model for cell growth	microbiological audit
microbial contamination control	FDA 21 CFR 210 regulations
FDA 21 CFR 211 regulations	microbiological inspection program
pharmaceutical manufacturing	biopharmaceutical
Drug Marketing Launch	Pharmaceutical Product Marketing Launch
drug marketing launch strategy	pharma product branding
drug positioning	best practices in pharma product launch
Effective CAPA training	CAPA and human error
preventing human error	CAPA for FDA regulated companies
CAPA process in commercial nuclear plants	CAPA in aviation
USP 1226 compliance webinar	verifying compendial methods
verification of compendial methods	compendial methods
USP chapter 1226 compliance training	510(k) Submissions
medical device 510(k) training	predicate device identification
Indented Use Definition	510(k) for device changes
device labeling requirements	substantial equivalence
medical device FDA inspection	FDA Inspection preparation
managing FDA Inspection	FDA Inspection training for medical device companies
FDA Inspection support team	Medical Device Process Validation
Process Validation for Medical Devices	Regulatory Approach for process validation
process validation components	HIPAA electronic security regulations
FDA Form 483	computer system validation cost reduction
CSV seminar	Computer System Validation seminar
FDA Inspection SOP	core inspection team
FDA sanctions	FDA law
FDA investigator	FDA warning letter
FDA 483	FDA inspection
RFP development seminar	Developing Request for Proposals
RFPs	Medical Device seminar
Medical device QMS	Quality Management System
21 CFR Part 820	MDR
CAPA	risk management process
OCR audit training	Breach Notification
OCR Privacy	hipaa security requirements
hipaa security audit	audit risk assessment
HIPAA HITECH Audit training	OCR HHS Audit requirements
HIPAA audit documentation requirements	HIPAA risk analysis
HITECH Act requirements	OCR Audit Protocol
OCR HHS audit preparations	HIPAA security risk analysis
HIPAA documentation	HIPAA audit protocol
HIPAA compliance tool	protected health information breach
managing PHI breach	PHI breach investigation
improper disclosures of protected health information	PHI breach incident mitigation
PHI breach management process	21 CFR Part 11 Regulations
FDA regulation of promotions	FDA regulation of product labeling
Off-Label Promotion of Pharmaceuticals	Off-Label Promotion of Medical Devices
ISO 13485 requirements training	QMS regulations for medical device manufacturers
medical device quality management system regulations	FDA QMS regulations
medical device QSR	FDA medical device
Medical Device Software Validation	medical quality system software validation
manufacturing and test software validation	Risk-based Software Validation
Medical Device Data Systems validation	MDDS
FDA design control requirements compliance	requirements management techniques
CMMi requirements management KPA	FDA compliance training
Transferring Medical Device Production	Decommissioning Medical device production
outsourcing medical device production	medical product contract manufacturing
document control compliance training	sterility test failures root cause analysis
RCA	IND application
FDA regulatory requirements	FDA Acceptance Criteria
non-US Clinical Trials	non-IND clinical trials
non-IDE clinical trials	South East Asia lifescience regulations
South East Asia Requirements to Conduct Clinical trials	South East Asia Licensing Products
South East Asia Variations and Amendments to Licenses	Adaptive clinical trials training
adaptive clinical trials design	adaptive clinical trials regulations
regulatory overview of adaptive clinical trials	challenges in adaptive clinical trials
Clinical Trial Study Protocol Training	key elements of clinical study protocol
GCP guidelines for clinical study protocol	consort statement
study protocol reporting requirements	Clinical Study Enrollment Metrics
clinical study status	budgeting for clinical trials
clinical study budgetary tracking	CRM study management reports
clinical research reporting	Standard Operating Procedures in Clinical Research
SOPs at the Clinical Research Site	ICH GCP guidelines for SOPs
regulatory audit of SOPs	SOP development
SOP implementation	Hemoglobinopathy clinical trials
hemoglobinopathy clinical research	sickle cell clinical research
thalassemia clinical research	clinical trials
clinical data queries	best practices in writing clinical data queries
regulatory guidelines for writing clinical data queries	clinical trial documentation
Clinical trial Data Management	FDA Requirements for OTC drugs
CPT codes for podiatric services	insurance guidelines for podiatry services
medicare guidelines for podiatry billing	Podiatry Billing
Podiatry Coding	Healthcare social media marketing
healthcare social media compliance training	HIPAA compliant social media usage
HIPAA regulations for social media	HIPPA violations in social media usage
Risk assessment training for healthcare organizations	risk-impact quotient for healthcare organizations
business impact analysis for healthcare organizations	healthcare compliance training
HIPAA Business Associates	2013 HIPAA HITECH act requirements
HIPAA privacy rule	. Health Information Exchanges
Regional Health Information Exchanges	HIPAA compliance
advertisements	DDMAC
FDA Requirements	FDA Regulated Products
Social Media Marketing	Avoiding serious FDA 483s
avoiding FDA Form 483 observations	FDA CGMP compliance audits
GMP internal audit guidelines	FDA audit approaches
FDA audit emphasis	Disinfectant Qualification Studies
Disinfectant Validation	Regulatory requirements for disinfectants
disinfectant testing methodologies	Standard Operating Procedures
SOPs	Code of Federal Regulations
Title 21	Title 493
regulatory errors	SOP validation
risk-based approach	Excel for audit trails
GxP compliant Excel spreadsheets	Develop and Validate Excel Spreadsheets
21 CFR Part 11 Compliance	Excel Spreadsheet Validation
electronic records requirements	Failure Investigation Methodology
Protected Health Information (PHI)	Extractables/Leachables Studies
Biotech Training	microbial contamination in raw materials
raw material testing	Microbiological Risk
raw materials risk management	Microbial Contamination of Raw materials
21 CFR Part 11	excel spreadsheet validation
FDA requirements	FDA Inspections
SOP for Bioanalytical Method Validation	clinical laboratory incident management training
laboratory incident management plan	lab compliance
GLP training	clinical laboratory patient safety
incident management requirements	Laboratory Investigation Checklist
FDA recommendations	OOS investigations
Laboratory Results Investigation	Out of Specification
Laboratory OOS Results	Laboratory Atypical Results
Clinical Study Forecasting	Clinical Trial Enrollment
clinical trial budgeting	forecasting clinical trial budget
forecasting clinical study enrollment	clinical study forecasting reports
clinical trial Statistical Analysis Plan	Statistical Principles for Clinical Trials
ICH E9 Guidance	Clinical Study Reports
Statistical Analysis Plan format	Statistical Analysis Plan content
Good clinical practices compliance training	handling GCP protocol deviations
GCP compliance	FDA GCP regulations
ICH GCP recommendations	clinical trial IRB compliance
Institutional Review Board	510k application seminar
510k submission	FDA 510k process guidance
FDA medical device submissions	medical device premarket notification
substantial equivalence	medical device compliance training
FDA import compliance	CBP compliance
FDA import requirements	foreign suppliers
overseas product import requirements	FDA regulated products
imported FDA products	FDAâ€™s Regulatory Procedures Manual
FDAâ€™s Investigations Operation Manual	Recall notification to FDAâ€™s District Office
FDA premarket guidance	FDA administrative
electronic records	FDA inspection
occupational exposure	OSHA requirements
blood borne pathogen standard	OSHA safety program
Blood borne pathogens	pharma capital project delivery programs
pharmaceutical project management	ECM training
Engineering Change Management training	Pharmaceutical Capital Projects
FDA Warning Letter	FDA 483s
Responding to FDA Warning Letters	FDA compliance
FDA warning letter closeout	FDA inspection process
Food safety	in plant validation
in-plant validation process	fundamental aspects
HACCP programmes	USDA-FSIS
food safety modernization act	monitoring and verification
quality assurance	Dietary supplement labeling
US market labeling	FDA classifications
principal display panels	supplements facts box
regulatory labeling requirements	types of dietary supplement claims
OSHA safety checklist	Global Medical Device Reporting
Global Medical Device Complaint Handling	global medical device regulations
Global Medical Device Vigilance reports	Healthcare Compliance
Federal Civil False Claims Act	Anti-kickback Statute
Stark Law enforcement	Anti-kickback Statute prohibitions
Stark Law prohibitions	Stark Law exceptions
safe harbors	bioburden limits for raw materials
stability study for biologics	WCP stability study
Personally Identifiably Information disclosure	PHI exchanges
protected healthcare data	medical records mangement
HIPAA compliance for PII	HIPAA compliance requirements for PHI
food marketing claims	FDA enforcement
FTC enforcement	consumer class action lawsuits
NAD	labeling claims
GMP regulations	raw material management
warning letters	raw materials
GMP requirements	EHR Incentive
Medicare and Medicaid	EHR incentive program
Electronic Health Records compliance	Medicare and Medicaid EHR Incentive
ICH GCP Guidelines	International Conference on Harmonization
Good Clinical Practice Guidelines	ICH GCP training
standardized GCP guidelines	ICH requirements
Dietary Supplement Adverse Event Reporting	Dietary Supplement Recordkeeping Requirements
Nonprescription Drug Consumer Protection Act	FDA regulations
CMC process	drug product development
CMC activities	pharma R&D
GLP	GMP
laboratory best practices	laboratory compliance
vaccine clinical trials	Vaccine Clinical Trial Regulations
Clinical Protocol	candidate vaccine testing
vaccine candidate approval	vaccine clinical trial design
FIM vaccine testing	computer system validation model
V-model	GAMP 5 for computer systems
ASTM E2500 for CSV	computer system validation implementation
computer system validation architecture	Quality Risk Management
Current ISO 13485 Requirements	medical device CAPA
Corrective Action	Containment
Device Correction	ISO 13485 audits
CAPA documentation	Nonconformities
medical device Quality System	Biotechnology Analytical Development
Design of Experiments	bioassay optimization
refining a biotechnology assay	biotechnology statistical techniques
bioassay quality control	emergency plan testing
Healthcare information system	security metrics
patient data security	HIPAA compliance
patient data privacy	healthcare information security
IT security metrics	OSHA Inspections
Accident Investigations	OSHA Inspection Guidelines
OSHA Complaint	Letter of Response
Surprise OSHA Inspections	OSHA Citation
Medical Foods Regulations	Medical Foods Regulatory Compliance
FDA Requirements for Medical Foods	FDA Medical Foods Regulation
Medical Foods Marketing compliance	Medical Foods labeling
QC for microbiology labs	FDA lab regulations
FDA lab compliance	lab test methods and validation
microbiology lab test methods	microbiology lab equipment
FDA compliance training	CMS Audit Preparation
CMS audit procedure	CMS audit guidelines
HIPAA compliance	HIPAA Privacy Rules
HIPAA Security Rules	CMS Audit
OOS Investigations	Pharmaceutical Laboratory
Best Practices	Out-of-specification investigation
OOT Investigation	Out-of-trend investigation
Biotech Training	Lyophilized Products
Container Closure Systems	closure system integrity
Vial types	vial formulations
vial leachables	vial extrcatables
medical device reimbursement	Medical Device Development
medical device Reimbursement Strategy	Centers for Medicare and Medicaid
CMS Reimbursement Approval	medical device reimbursement rates
Documentation process	Clinical Site Audit
Types of FDA Audit	GLP Audit
GMP Audit	GCP Audit
FDA Audit	GMP training
Effective GMP trainings	GMP training techniques
compliance training	effective compliance trainings
learning techniques	Learning Principles
Training Delivery Methods	Dietary Supplement Labeling
Labeling Claims	Marketing Claims
dietary supplement claims	FDA labeling requirements
labeling dietary supplements	FTC labeling requirements
Warning Letters	lockout program
New Dietary Ingredients	Draft Guidance
FDA Updates	dietary supplement regulations
Labeling Issues	Regulatory Compliance
Dietary Supplements	EU requirements for mobile medical applications
FDA requirements for mobile medical apps	FDA Software Regulations
medical device software	mobile medical applications
Conventional food labeling	US market labeling
FDA classifications	principal display panels
supplements facts box	regulatory labeling requirements
types of dietary supplement claims	GMP Audit
Statistics for GMP Auditors	GMP Auditing
Statistics Used in GMP Auditing	Acceptance Sampling Plans
Sampling API Shipments	FDA Laboratory regulations compliance
fish smoking	fish curing methods
fish packaging	HACCP
cured fish	smoked fish
curing fish	food preservation methods
smoked salmon	fish canneries
seafood production plant	fish processing plan
Lab Compliance	Lab Compliance Plan
Medicare Guidelines	Medicaid Guidelines
Laboratory compliance	OIG compliance
HHS compliance	PPACA 2010 compliance
OIG enforcement	Medicare fraud
Medicaid a	Over-the-Counter Drug Products
OTC drug labeling	OTC Drug Sales and Marketing
FDA enforcement action	FDA regulatory compliance
CGMPS for combination products	combination product regulations
21 CFR Part 4 requirements	FDA regulation of combination products
Biologics	China SFDA regulations for Combination Products
Pharmaceutical Water Systems	Microbial Contamination Control
Biofilm in Pharmaceutical Water Systems	water system deviation investigations
pharmaceutical water system design	Physician Payment Reporting
Physician Payment Tracking	Physician Payment Sunshine Act
Sunshine Act Final Rule	Reporting Surgical Assistants
CMS Guidelines	assistants at surgery
centers for medicare and medicaid services	modifiers for surgical assistants
limiting OSHA investigations scope	OSHA inspection scope
OSHA inspection procedures	Food Recall Insurance
food contamination insurance policies	food contamination recall
liability insurance programs	comprehensive general liability coverage
Clinical Investigator Responsibility	Principal Investigator responsibility
Drug Development Process	FDA Regulatory Control
FDA form 1572	FDA GCP compliance
clinical compliance	IND filing requirements
pharmaceutical regulatory filings	IND format
IND content structure	CMC requirements
BLA application	505(b)(2) application
NDA application	GMP analytical laboratory audit
FDA 21 CFR 211 training	analytical method execution requirements
FDA analytical laboratory audit	ICH guidelines Q1 series
FDA consent decrees	FDA warning leters
Code of Federal Regulations	FDA GMP requirements
FDA non-compliance	FDA site visit
Supplier Controls	U.S. FDA Requirements
Supplier Ranking Models	CGMP compliance
supplier management	supplier audit
Drug Products	Orphan product requirements
FDA meetings for orphan products	FDA guidance for orphan products
orphan product development strategies	FDAâ€™s review process for orphan products
Asian Medical Device Regulations	Asian Medical Device Laws
China Medical Device Laws	Japan Medical Device Regulations
Hong Kong Medical Device Laws	Korea Medical Device Regulations
Asia device	safety plans
OSHA compliance	written safety plan
I2P2	safety documentation
federal OSHA requirement	Disinfectant Validation Training
Cleanroom Cleaning Training	FDA Disinfectant Regulations
EMEA Disinfectant Regulations	FDA Cleanroom Cleaning
EMEA Cleanroom Rules	FDA Disinfectant Compliance
Vaccine Testing	Vaccine Development
Vaccine Approval Process	Laboratory Vaccine Testing
Human Vaccine Testing	vaccine candidate testing
regulatory process	Smart Phones and HIPAA
HIPAA requirements for Texting	HIPAA requirements for Email
Patient Information Security	Patient Communication and HIPAA
HIPAA Compliance	USA telehealth regulations
telemedicine regulations in the US	telemedicine reporting requirements
telemedicine documentation requirements	telemedicine services
Sunshine Act requirements	Quality Monitors
Clinical Research Site QA	QA for Clinical Research Sites
clinical site quality system	Quality Assurance Program
Good Clinical Practices	FDA GCP regulations
ICH guidelines	Medical Device Data Systems
MDDS Ruling	new MDDS requirements
FDA MDDS requirements	MDDS final rule
FDA MDDS rule	MDDS training
OSHA Recordkeeping Analysis	Recordkeeping Regulations
OSHA Interpretation Letters	OSHA recordkeeping citations
OSHA 300 Log	OSHA recordkeeping practices
medical device supplier management	Supplier Quality Agreements
FDA QSR Requirements	FDA vendor compliance
FDA compliant supplier management system	FDR QSR documentation
Auditing Systems for 21 CFR Part 11 Compliance	Federal
State Regulatory Inspections	Computer Systems Assessment
Validating Manufacturing Control Systems	MCS Validation
MCS Compliance Requirements	Electronic Batch Records
FDA consent decree	Fair Market Value
Commercial Reasonableness	FMV Compensation Issues
fair market value compliance issues	documentation methodologies
healthcare compensation issues	Compensation stacking
EU MDD	Medical Device Directive
Medical Device Risk Management Procedure	CE Mark requirements
Medical Device Risk Analysis	ISO 14971:2012 compliance
Disruptive Healthcare Practitioner	Disruptive Practitioner Policies
Hospital Policy	Hospital Staff Management
documenting disruptive behavior	Disinfectant qualification compliance
FDA regulations compliance training	clinical laboratory compliance training
clean room operations compliance	laboratory disinfectant qualification
laboratory	Medical Device Risk Management File
Post-Approval Risk Management Strategy	ISO 14971 requirements
risk evaluation and mitigation strategies	REMS
FDA warnings	FDA Warning Letter Compliance Training
FDA compliance training	FDA warning letters
FDA inspections compliance	Clinical trial compliance training
FDA clinical trial audits	FDA sponsor inspections
clinical trial sponsor monitoring programs	clinical trial quality monitoring
Training on Anti-Kickback law	training on Stark law
Compliant Marketing Practices	marketing violations
preventing ID theft	risk exposure
FDA cosmetics label regulations	cosmetic product labeling
FDA labeling requirements for cosmetics	FDA cosmetic ingredient limitations
FFDCA cosmetic regulations	Assay validation
clinical diagnostics	assay transition
assay validation plan	research assay
clinical assay	assay validation protocol
assay validation guidelines	assay validation report
Food cGMPs	Food GMP training
GMP Training for Food Manufacturers	GMP Training for Food Processors
FDA 21 CFR requirements	FDA food GMP guidelines
FDA cGMP guidelines	FDA cGMP compliance audits
FDA cGMP audit	FDA audit training
FDA audit preparation	good manufacturing practices compliance
FDA regulations compliance	Medical Staff Litigation
Fair Hearing Policy	Medical Staff Adverse Action Hearings
corrective action	fair hearing plan
hearing process for adverse actions	adverse peer review action
Pharmaceutical Water System	Water System Biofilm
Remediating Biofilm	Water System Monitoring
pharma water system sanitization	biofilm removal
microbial controls	Purified Water systems
Medical Device Reporting	MDR regulation
21 CFR 803 requirements	medical device adverse events
voluntary reporting mechanism	FDA Event codes for MDRs
Dietary supplements	Nutraceuticals
GMP	FDA
Cosmetics Claims	Cosmetics Labeling
cosmetics advertising claims	cosmetic product
FDA regulation of cosmetics	FTC regulation of cosmetics labeling
Randomized Control Trials	Design of Non-inferiority Trials
Design of Equivalence Trials	clinical trial design
developing clinical questions	FDA guidances for NI trials
Surprise OSHA Inspections	Letter of Response
OSHA Complaint	OSHA Inspection Guidelines
Accident Investigations	OSHA Inspections
FDA warning letters	FDA Enforcement
Medical Device Warning Letters	Warning Letter Response
Communicating with the FDA	Generic Drug Product Development
ANDA filing	Paragraph 4 Filing
Branded Patent Expiration	Bioavailability for generic drugs
Scope of FDAâ€™s Inspection Authority	FDA's Access of Company Records
preparing for an FDA inspection	Scope of FDAâ€™s Inspection Authority
FDA's Access of Company Records	preparing for an FDA inspection
Portable Devices and HIPAA	The 2013 Medical Device Tax
Affordable Care Act of 2010	scope and applicability
Medical Device Tax	veterinary medical devices
FDA Supplier Audits	Bio-pharmaceutical Supplier Audit
Medical Device Supplier Audit	FDA Supply Chain Oversight
vendor oversight	Healthcare Compliance Issues
Healthcare Settlements	False Claims Act amendments
Stark Law update	Stark law exceptions
Compendial Methods	Medical Device QSIT
Quality System Inspectional Technique	21 CFR 820
FDA medical device inspections	Management Controls
Design Controls	Corrective and Preventive Actions
CAPA	medical device
"Food Safety Audit	Food Quality System Audit
Third Party Audit	Audit Types
GFSI Audit	Third Party Audit
Clinical Trial Recruitment Methods	human subject recruitment
Clinical Trial Recruitment Metrics	Clinical Study
clinical trial enrollment	510(K) basics training
510(k) Submission	Premarket Notification 510(k) process
Class II medical devices	Medical Device Registration Requirements
disinfection	Global Medical Device Regulations
Global Medical Device Laws	US Medical Device Laws
EU Medical Device Regulations	Canada Medical Device Laws
Global device regulatory framework	Deviation Investigation in FDA Regulated Industries
FDA Compliant Investigation of Deviations	Root Cause Analysis for Deviations
FDA 483s	FDA Warning Letters
Avoiding FDA Penalties for Deviations	FDA Food Safety Modernization Act Compliance
FSMA Compliance	food safety law
food safety law requirements	food safety compliance
managing stability changes	registration stability program
change control system	Drug CMC changes
Pharmaceutical Stability Program	claim denial appeal letter
sample appeals letters	Writing Effective Appeals
Orthopedic Denials	Orthopedic claims processing
clinical investigator payments	disclosure requirements
Clinical Trial Reporting	The Sunshine Act
Lab data analysis	Drug Development Process
Adverse Event determination	clinical research safety monitoring plan
FDA Social Media Regulations	Promoting Life Science Products Using Web 2.0
FTC Laws and Regulations	off-label promotion in social media
Web 2.0 advertising	drug marketing claims
Medicare Coverage Analysis	MCA
Clinical Trial Policy	CTP
National Coverage Decision	NCD
Clinical Trials	OSHA Interpretation Letters
OSHA Recordkeeping training	OSHA Compliance
300 Log	laboratory reagents
reagent qualification	reagent validation
laboratory compliance	lab vendor qualification
GLP laboratory	GMP laboratory
bioequivalence regulations	pharmaceutical equivalence
therapeutic equivalence	approval of bioequivalent medications
bioequivalent drug marketing	bioequivalent drug approval
Food Allergen Control	sources of food allergens
common food allergens	cross contamination prevention
best practices in food allergen control	allergen labeling
Dietary supplements quality compliance	FDA regulatory requirements for dietary supplements
nutraceuticals quality compliance	food drugs quality compliance
dietarty supplements submission	FDA Software Validation Guidance
"FDA Software Validation	Compliance in Software Verification and Validation processes
FDA Compliant Software Verification and Validation	Japan CRO selection
process filings	PMDA requirements
MHLW	Life Science regulations
Japan Regulatory Compliance	QA plan
CLIA guidelines	software evaluation for FDA industries
software selection for FDA compliance	21 CFR Part 11 Regulations
FDA compliant computer systems	software vendor evaluation
medical device software	Premarket Submission
Medical device software Validation	device cybersecurity
mobile medical apps	FDA regulation of biomedical software
MDDS rule	FDA Vaccine Regulations
vaccine development in the USA	vaccine safety regulations
vaccine potency testing	vaccine testing in animals
FDA animal rule	guidance for electronic records
clinical trial regulations	FDA Part 11 guidance
Stark Law Exceptions	Non-Monetary Compensation Arrangement
Medical Staff Incidental Benefit Exceptions	Clinical Investigator Financial Disclosure
21 CFR Part 54 Requirements	FDA financial disclosure
clinical investigator compensation	form 3455
financial disclosure form	SOP design
SOP writing procedure	SOPs for regulated industies
FDA compliant SOPs	Standard Operating Procedures
CMS inquiries	Sunshine Act Rules of 2013
New Medicare Reporting Requirements	CMS Final Rule
Center for Medicare and Medicaid Services	GRAS status
FDA's New Dietary Ingredient Draft Guidance	Dietary supplement ingredients
dietary supplement labeling compliance	FDA labeling requirements
FDA Inspections	QSIT Inspection
CAPA Process Inspection	Quality Inspection
Quality Systems Inspection	FDA documentation
Design Validation Protocol	Chromatographic Methods
ICH requirements	pharma good manufacturing practices
Stem Cell	Pharmaceutical
Drug Products	FDA
biologic	FDA's Regulation
CE Marking	EU MDD
MDD requirements	Technical File
Essential Requirements Document	Clinical data methods for medical devices
FDA pharma regulations	OOS
Out of Specification	OOT
Out of Trend	OOS investigation
OOT investigation	OOS/OOT investigation guidance
corrective and preventive actions	CAPA
laboratory quality systems	ISO laboratory standards
lab quality system compliance	good laboratory practices
ISO 17025 compliance training	FDA 21CFR 514 requirements
medical device stability testing	Drug stability testing
Healthcare-associated infections	HAI regulatory requirements
healthcare-acquired infections	facility acquired infections
HAIs	HAI prevention
Commercial Food Packaging	Air Quality Control
ISO 8573-1:2010 Compliance	updated ISO 8573 regulations
air purity tests	HIPAA
Medicare Secondary Payer Rule	Community Health Systems
CHS	Clinical Research in CHS
clinical research compliance	Anti-Kickback Statute
GMP Audit	Non-conformance
OOS resolution	HIPAA NPRM
HHS OCR audit	HIPAA audit
HIPAA 2	HIPAA compliance
new HIPAA regulations	new data security rule
HIPAA Privacy Act	interim final rules
IFRs	Investigation
OSHA investigation processes	Initial FDA Meeting
FDA inspection Scribes	medical device reports (MDR)
FDA QSR	FDA medical device compliance best practices
US medical device regulations	FDA enforcement
dietary supplement claims	food safety compliance
Chemical Control in Food Manufacturing	Chemical Safety in Food Manufacturing
CFR 21 Part 110 requirements	Food cGMPs
food chemical contamination	International product registrations
International Medical Device registrations	International drug product registrations
product registration documentation	Physician benefit exceptions
EU medical device quality systems	medical device quality professionals
MDD implementation	medical device directive
EU medical device regulations	medical device quality management
medical device	FSMA audit
food safety audit	FDA Compliance
GMP for Cosmetics	FDA Regulation of Cosmetics
financial reporting for physicians	Healthcare Contractual Fraud Detection
HIPAA Security Rule Compliance	HIPAA Audit
managed care contracting	network development
healthcare provider relations	healthcare waste program
healthcare	Trial Master File
TMF	clinical trial regulatory file
Clinical Research Coordinator training	CRC training
TMF fundamentals	clinical research documentation
Pharmaceutical Water System	Water System Biofilm
Remediating Biofilm	Water System Monitoring
pharma water system sanitization	biofilm removal
microbial controls	Drug Stability Guidelines
Coding for Infusions and Injections	Reimbursement for Infusions and Injections
CPT and CMS Updates	infusion codes
injection codes	2013 CPT update
CPT time based codes	HCPCS updates
OSHA online training	OSHA inspection process
OSHA regulations	OSHA safety training
Temporary employee OSHA requirement	FDA enforcement
food safety modernization act	GMP history
21 CFR Part 110	21 CFR Part 111
Food and Dietary Supplement GMPs differences	implementation of GMPs
healthcare Fraud and Abuse Laws	health care reform legislation
ISO 14971	ISO 14971 risk management
medical devices risk management	ISO 14971 compliance standards
risk mitigation	device risk management strategies
hazard analysis	Software Validation Compliance

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