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: www.gmptrainingsystems.com/resources
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.
www.GMPTrainingSystems.com
Serving 1953 clients since 1989
Upcoming Boot Camps
Click below for our 2011/2012 schedule
www.gmptrainingsystems.com/public-workshops
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
www.gmptrainingsystems.com/web-seminars
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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