Seminar - Online
This webinar will discuss the Consideration of IQ, OQ, and PQ and their equivalents for processes, equipment (production and test), product, and CGMP e-records / e-signatures. 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 product / equipment / process V&V requirements and execution. And now the FDA is taking an even tougher stance. Why do companies need robust V&V? What are the "must have" elements from the CGMPs and best practices? How do you define and use IQ, OQ, PQ, or their equivalents? 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? While focused on CGMP compliance, it is suitable for ISO 13485 and ISO 9001 (international / global) compliance as well.
Organization: Compliance Trainings (https://compliancetrainings.com)
For more information, please visit: https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1544
Tuesday, August 18, 2015 (13:00 - 14:00)
Mississauga, Ontario 44813, Canada
Contact: Compliance Trainings (suzzane.d@compliancetrainings.com)
Phone: 4169154458
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