How To Prepare for an FDA Inspection - A Practical Prospective


Instructor: James Harris(PhD)
Product ID: 700646

  • Duration: 60 Min
This FDA Inspection training/webinar is designed to provide an overview of the GMP regulation and how FDA inspects a facility to assure compliance with them. Knowing this, suggestions are made to prevent FD 483 citations.
Last Recorded Date: Oct-2007


1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
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1 USB is for usage in one location only. info CD/USB and Ref. material will be shipped within 15 business days
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Read Frequently Asked Questions

Why Should You Attend:

As we know all too well, the pharmaceutical industry an it’s allied industries are among the most heavily regulated businesses in the United States. One of the things that we can depend on is that from time to time, an FDA investigator will arrive unannounced to perform an inspection to see if we are following all of the applicable GMP regulations. The inspection may take a few hours or it may take far longer. No matter what, we must always be prepared for an inspection. This presentation will provide practical advice regarding how to prepare for these inspections so that your facility will pass with flying colors.

Areas Covered in the seminar:

Critical areas of inspection and how to prepare for them:

  • Basic survival rules
  • Organization & Personnel
  • Buildings, Facilities & Equipment
  • Controls
  • Records & Reports
  • Returned and Salvaged Products
  • The FD 483 - Hoe to deal with it

Who Will Benefit:

This program is designed to provide an overview of the GMP regulation and how FDA inspects a facility to assure compliance with them. Knowing this, suggestions are made to prevent FD 483 citations.

This program will be of value to all personnel responsible for the following functions:

  • Manufacturing managers, supervisors & personnel
  • Quality Assurance personnel at all levels
  • QA auditors
  • QC managers & staff
  • Consultants to the industry

Instructor Profile:

James R. Harris,, PhD is a veteran of the pharmaceutical Industry and the president of James Harris Associates, an international consulting firm that specializes in the regulatory aspects of pharmaceutical, Biopharmaceutical, and device manufacturing. Dr. Harris played a vital role in establishing many of the regulations in existence today, with particular emphasis on validation of all types. He authored the original validation guideline for computerized systems used in drug manufacturing and has recently written a chapter on GMPs for the Pharmaceutical Manufacturing Handbook which will be published soon by John Wiley & Sons.

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Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).




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