Unannounced FDA GMP inspections - don't let it be your downfall

Instructor: Peter Calcott
Product ID: 701524
  • Duration: 87 Min

recorded version

1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section

Training CD

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Read Frequently Asked Questions

This GMP inspection Webinar training will discuss how to prepare for an unannounced FDA GMP inspection and more over how to predict when they occur and how you should be ready to face it.

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 are the most likely areas to be covered. This becomes the plan for gap analysis and checking on your commitments from the last inspection. The successful inspection is when you manage the 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.

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.

Areas Covered in the seminar:

  • Can you prepare for an unannounced inspection? - yes.
  • When do you 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 repsonse to the observations in place.
  • Following up on the commitments.

Who will benefit:

This Webinar is useful for all companies in pharmaceutical and biotech industries. All staff from following department must attend this course
  • Quality and Compliance
  • Regulatory Affairs
  • Manufacturing
  • Validation
  • Senior management
  • Drug Safety

Instructor Profile:
Peter Calcott, Ph.D. is founder and President of Calcott Consulting which serves the biotech, pharma and venture capital industry. It provides consulting services in supply chain, quality systems, clinical development, regulatory affairs, compliance and governance, enterprise e-solutions and government affairs. It also provides corporate strategy development, analysis and assessment especially due diligence evaluation.

He has held positions in industry in all these disciplines over a 30 year career. He has presented at national meetings and is active in the biotechnology community via BIO and the bay area BayBio trade associations where he is chairman of the BIO RAC committee and a Board member of BayBio.

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