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34594 Conferences

Understanding and Preparing for FDA's New Part 11 Inspection Program

Added by Referral on 2010-08-12

Conference Dates:

Start Date Start Date: 2010-09-24
Last Date Last Day: 2010-09-24

Conference Contact Info:

Contact Person Contact Person: admin
Email Email:
Address Address: 2600 E. Bayshore Road, Online Event, CA, 94303, United States
Phone Tel: 650-620-3915
Phone Fax: 650-963-2556

Conference Description:

This Part 11 Inspection training will answer all questions related to the new part 11 inspection program by FDA and FDA expectation of implementing part 11 requirements.

Areas Covered in the Seminar:

FDA inspections: Preparation, conducts, follow up.
Scope of the new Part 11 program: time frame, expected outcome.
Criteria for selection of target companies.
What will inspectors be looking for.
How to prepare your company for the upcoming inspections.
Learning from previous inspections with focus on Part 11 and computer validation: most frequently cited deviations.
How to fill gaps short term.
Developing a program for long term.
Creating the right documentation to satisfy the inspectors.
Most likely next steps after the inspection program.
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