Surprise FDA GMP inspection - how to prepare for it

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

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
Last Recorded Date: Feb-2009

Training CD / USB Drive

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

Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

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.

Follow us :
Supplier and Contract Manufacturer Management
Domestic and Foreign FDA Inspections and the COVID-19 Impact

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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