GMP Tips

A portal for Good Manufacturing Practice compliance tips for the Life Sciences industries.

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Be Prepared for an FDA Inspection

October 17th, 2011 · No Comments · Uncategorized

One good method for being prepared for an FDA inspection is to read FDA’s own Investigations Operations Manual. Chapter Five of this manual addresses Establishment Inspections. Download and read Chapter Five here:
Click on FDA Resources

Another good way to prepare for an FDA inspection to to keep current. We offer web seminars on timely topics and public workshops – our popular Boot Camps. See below for a listing of upcoming events.

Serving 1953 clients since 1989

Upcoming Boot Camps
Click below for our 2011/2012 schedule

GMP Boot Camp – Fundamentals of GMP and QSR
Oct 19 – 20  Newark, NJ

Validation Boot Camp
Feb 15 – 16 Philadelphia, PA

GMP Boot Camp – Fundamentals of GMP and QSR
Mar 7 – 8 Anaheim/Newport Beach, CA

Upcoming web seminars
Cost effective & Convenient – in your office or conference room

Implementing FDA’s Guidance on a Quality Systems Approach to Pharmaceutical cGMP Regulations
Oct 28

Outsourcing in the Healthcare Industry: Avoiding the Perils and Pitfalls
Nov 4

How to Implement FDA’s New Guidance on Process Validation
Nov 11

ASTM E2500 Consensus Standard: An Overview of a New Approach to Validation
Nov 18

Proven Steps to Reducing Waste in Process Validation
Dec 2

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