Surprise FDA GMP inspection - how to prepare for it

Instructor: Peter Calcott
Product ID: 701203
  • Duration: 90 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556


Read Frequently Asked Questions

This FDA GMP (Good Manufacturing Practice) inspection training 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.

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 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 (Good Manufacturing Practice) inspection.
  • Putting a strong repsonse 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
  • Senior management
  • Manufacturing staff
  • Validation
  • Regualtory affairs staff

Instructor Profile:

Peter Calcott, the founder and president of Calcott Consulting, a consulting form focused on delivering solutions in supply chain, manufacturing, quality, clinical development and regulatory affairs for biologics and drug companies. He has presented at national meetings and is active in the biotechnology community vie BIO and the bay area BayBio trade associations where is chairman of the BIO RAC committee and a Board member of BayBio. He has over 30 years experience working at small start-up biotech as well as large Pharma companies in the areas of manufacturing, process science, and quality, clinical and regulatory affairs.

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