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POST ID: 5717

Webinar On Master Validation Planning To Meet U.S. FDA cGMP, ISO 13485, and ICH Q9 / ISO 14971 Requirements

Region: Canada
Location: Mississauga, ON


This 90 minute in-depth webinar discusses the FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies, many going back to insufficient, poor or non-existent V&V planning.
And now, the FDA is taking an even tougher stance.
Why do companies need a Master Validation Plan?
What are the "must have" elements from the cGMPs?
How do ISO 14971 and ICH Q9 for hazard analysis and product risk management factor in and assist to allocating limited company resources?
How can these be integrated into the company's quality management system?

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