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This 90-minute session on risk-based verification and validation planning will discuss "must have" elements from the U.S. FDA cGMP, ICH Q9 and ISO 14971 for hazard analysis and product risk management, and show how you can integrate these into a company's quality management system.Why Should You Attend:FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies. And now the FDA is taking an even tougher stance. One major failing…See More

This ICH Q10 training /webinar will discuss the evolution and interpretation of the pharmaceutical GMPs as a quality control regulation to the Quality Assurance emphasis of the Pharmaceutical Quality System as defined in ICH Q10.Why should you Attend:Since the release of the Quality System Regulation for medical devices, the FDA has been trying to transition the pharmaceutical industry to a Quality System approach to compliance. The issuance of the Guidance for the Industry: Quality System…See More

This ICH Q10 training /webinar will discuss the evolution and interpretation of the pharmaceutical GMPs as a quality control regulation to the Quality Assurance emphasis of the Pharmaceutical Quality System as defined in ICH Q10.Why should you Attend:Since the release of the Quality System Regulation for medical devices, the FDA has been trying to transition the pharmaceutical industry to a Quality System approach to compliance. The issuance of the Guidance for the Industry: Quality System…See More

"Computer System Validation - Reduce Costs and Avoid 483s" - This course is certified by RAPS. Attendees are eligible for 12 RAC points on completion of the Seminar.See More