World Conference Calendar

35128 Conferences

Risk-Based Verification and Validation Planning to Meet U.S. FDA, ICH Q9 and ISO 14971

Added by Referral on 2011-01-19

Conference Dates:

Start Date Start Date: 2011-02-08

Conference Contact Info:

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

Conference Description:

In this V & V planning training Webinar learn to create a Master Validation plan, evaluate its elements against ISO 14971, ICH Q9 for hazard analysis and Risk management. How to employ DQs, IQs, OQs and PQs.

Why Should You Attend:

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based V&V planning. Why do companies need a Master Validation Plan? What are the must have elements from ISO 14971 and ICH Q9 for hazard analysis and product risk management? How can these be integrated into a company's quality management system.

Areas Covered in the Seminar:

Verification or Validation -- Recent regulatory expectations.
The Master Validation Plan.
Product V&V versus Process / Equipment V&V.
When and How to Use DQ, IQ, OQ, PQ.
Using the Risk Management tools of ISO 14971 and ICH Q9.
The 11 Elements of the Software VT&V "Model".
Avoid recent "horror stories" and multimillion dollar fines.

Note: Use this promocode(117660) for 10% discount.
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