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  • Effective Training Practices for FDA Compliance

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Thursday - Jan 23, 2014 10:00 AM
  • End Time:
  • Thursday - Jan 23, 2014 11:00 AM
  • Location:
  • Online
  • This FDA compliance webinar will help the attendees develop an effective training program and training plans for an organization. Attendees will learn GxP training requirements in US and EU.

    Why Should You Attend:
    No or inadequate training of employees is one of most frequently cited deviations in FDA inspectional observations and warning letters. Trainings are either not planned, not conducted, not evaluated or not documented as expected by inspectors. On the other hand it has been is estimated that about 5% of employee's time is spent for training. So there seems to be lack of understanding on what the regulations are, their interpretations and expectations of inspectors.

    What Attendees will Learn:
    -GxP training requirements in US and EU.
    -Most frequently cited deviations.
    -Developing an effective training program for a company, site or department.
    -Developing a training plan for individual employees.
    -Who can or should be responsible for the training program and training plans.
    -Most efficient training tools for different tasks.
    -Assessment of successful participation.
    -The benefits of risk based training.
    -Documentation of trainings for the FDA.
    -Specific training requirements for part 11.
    -For easy implementation, Attendees will receive:
    -Primer: Successful compliance training (20 pages).
    -SOP: Training for GMP Compliance.
    -SOP: Training for GxP, 21 CFR Part 11 and Computer Validation.

    Who Will Benefit:
    -Pharmaceutical and medical device industry
    -Manufacturers of pharmaceutical ingredients
    -Training departments
    -QA managers and personnel
    -Analysts and lab managers
    -Validation specialists
    -Regulatory affairs
    -Human resources (HR) managers and staff
    -Documentation department

    Instructor Profile:
    Ludwig Huber, Ph.D., is Director of Labcompliance and editor of, the global on-line resource for validation and compliance issues for laboratories. Mr. Huber is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare. Dr. Huber has given more than 200 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars and presentations for the US FDA, ISPE, PDA, PIC/S and several national health agencies. For more information, visit Dr. Huber’s website:
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