The meanings and regulatory requirements of the terms "verification" and 'validation' are often confusing to engineers and even some regulatory professionals. Operations managers are even less well versed. FDA regulations as well as European standards such as ISO 13485:2003 require both verification & validation documentation throughout these regulations and standards. The terms apply to design control, process control and others. Numerous warning letters on this subject has been issued by FDA to well known manufacturers. Verification and validation also appear in the “essential requirements” in MDD 93/42/EEC needed for CE marking medical devices in the European Union. Good engineering practices in all industries benefit from well executed verification and validation studies.
Areas Covered in the seminar:
Who will benefit:
Companies wishing to understand the risks and complications involved with the application of sound verification and validation principles will gain a better understanding of the differences and benefits. Employees who will benefit include:
John Chapman, BS, MBA, RAC has over 30 years medical device regulatory experience and over 10 years experience with the European Union’s medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking. He has performed regulatory due diligence on over a dozen acquisitions in the past 12 years, exposing him to numerous quality systems, including consent decrees as well as many notified bodies. He earned his regulatory affairs certification (RAC) in 1998 and was a contributing author to 2004 Fundamentals of EU Regulatory Affairs, RAPS, 2004. He co-founded a local RAPS chapter and has been a speaker at these meetings and the annual RAPS conference.
John has had specialized training and experience in FDA QSR, ISO 13485, European Medical Device Directives, ISO 9001, Canadian Medical Device Regulations, Auditing, Root Cause Analysis, Design Control, Bloodborne Pathogens, Hazardous Waste Handling, and FDA regulations. He has also presented live on-line seminars on various regulatory subjects.
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