ComplianceOnline

How To Prepare for an FDA Inspection - A Practical Prospective

Instructor: James Harris(PhD)
Product ID: 700646
  • Duration: 60 Min

recorded version

$249.00
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

$500.00
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

Email: customercare@complianceonline.com

Read Frequently Asked Questions

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.

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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