Risk-Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements

May 19, 2020 - FL US

WCS Consulting Inc

subscribe@worldcomplianceseminars.com
Phone:3472825400

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies on both sides of the Atlantic. One major failing is lack of sufficient or targeted risk-based V&V planning. This webinar will review company's Validation Master Plan for major cGMP deficiencies and risk management tools per ISO 14971 and ICH Q9. Major industry failings are lack of sufficient or targeted risk-based V&V planning.

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