Event:
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Design Validation Protocol and Acceptance Criteria for
Chromatographic Methods to meet ICH requirements
- Hosted By:
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ComplianceOnline
- Start:
- Wednesday - Jul 10, 2013 10:00 AM
- End Time:
- Wednesday - Jul 10, 2013 11:00 AM
- Location:
- Online
- This Design validation 60 min session will discuss how to write validation protocol and determine acceptance criteria. It will also explain the systematic approach to validate analytical procedures.
Why Should You Attend:
Analytical procedures are used to assure that the drug product meets applicable standards of identity, strength, quality and purity during its shelf-life. The majority of analytical methods used in pharmaceutical development are HPLC analyses. cGMPs require validated stability indicating methods used to monitor the drug product’s stability profiles.
This interactive 60 Min course will examine validation parameters for HPLC methods used in pharmaceutical laboratories based on cGMP regulations and ICH guidelines. It will discuss proved forced degradation strategies to develop stability-indicating analytical procedures. Learn effective way to write validation protocol and determine acceptance criteria for validation, make documentation more manageable. This course will provide a practical and systematic approach to validate analytical procedures.
Areas Covered in the Seminar:
- Regulatory Requirements for Analytical Test Methods
- Discuss Drug Development Process
- Understand cGMP requirements for analytical test methods.
- Review ICH Q2 A&B guidelines for method development/validation.
- Designing Method Validation Protocols
- Establish acceptance criteria for validation.
- Website:
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Visit the website for detail info