How to prepare for the unannounced FDA compliance inspection
Instructor:
Peter Calcott
Product ID: 700892
- Duration: 60 Min
Why Should You Attend:
Although unannounced GMP inspections happen when you least expect them, it is possible to predict when they occur. With this knowledge, you can predict when you must be ready. By examining the "hot topics" and your track record with the agency, you will be able to determine what the most likely areas to be covered are. This becomes the plan for gap analysis and checking on what you said you would do at the last inspection. The successful inspection is when you manage your agency’s expectations and then deliver on them. After the inspection, the responses are also very critical to prevent it from becoming a warning letter or even worse.
Areas Covered in the seminar:
- Can you prepare for an unannounced inspection? - yes
- When to begin the preparation.
- What to expect from the inspection.
- What are the hot topics to focus on?
- How to determine your weak points.
- How to best train people for a routine GMP inspection.
- Putting a strong response to the observations in place.
- Following up on the commitments.
Who will benefit:
This webinar will walk you through the elements you should plan for, the timing and the logistics of who should do the various components in preparation for the inspection. We will walk you through successful inspection strategies and logistics. After the inspection the putting together of a solid systemic CAPA is described and a process for tracking completion.
- QA and Complaince staff
- Process development staff
- Manufacturing staff
- Validation
- Regulatory affairs staff
- Project managers
Peter Calcott,, Ph.D. is the President of Calcott Consulting, a consulting firm focused on supply chain, quality, clinical development, regulatory affairs and corporate compliance. He has over 30 years experience in the industry having positions in Quality, manufacturing, process development, compliance. He has worked for large Pharma as well as small biotechnology companies. He has licensed and introduced new products to the marketplace on 6 continents.
More Training By Experts
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