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Unannounced FDA GMP inspections

Webinars - Unannounced FDA GMP inspections

By : Compliance Online

Date : 2011

Location : United States US / Palo Alto

Video 01h 27m
Description :

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.

Keywords :

FDA, GMP, Food and Drug Administration, Good manufacturing practice,


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.




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


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.


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.

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

Product Type : On Demand Webinar

Author : Peter Calcott

Video 01h 27m

Languages : English

Organizer : Compliance Online

ComplianceOnline is a Regulatory Affairs Professionals Society(RAPS) RA Professional Development Portal provider. ComplianceOnline is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs ComplianceOnline has agreed to follow RAPS-established operational and educational criteria