Effective Training Practices for FDA Compliance
Instructor:
Dr. Ludwig Huber
Product ID: 701243
- Duration: 75 Min
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 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.
Areas Covered in the Webinar:
- 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.
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
- Consultants
Dr. Ludwig Huber
Director and Chief Editor, Labcompliance
Dr. Ludwig Huber, Ph.D., is the director of Labcompliance and editor of www.labcompliance.com, the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems". He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national health care agencies.
More Training By Experts
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- Effective Training for FDA Compliance: What to train - How much to Train - How to Document Effectiveness
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