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.
The meanings and regulatory requirements of the terms “verification” and “validation” are often confusing to engineers and even some regulatory professionals. 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. 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:
- Verification & validation types.
- Definitions.
- Design control.
- Process control.
- Application
- Consequences of poor verification & validation.
- Why verification & validation makes good business sense?
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:
- Quality & Regulatory Professionals
- Manufacturing & Design Engineers
- Marketing Product Managers
- Corporate & Operations Executives
Instructor Profile:
John Chapman, BS, MBA, RAC has over 30 years medical device regulatory experience and over 15 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. RAB Accredited Lead Auditor Course Certificate1996. 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 seminars on various regulatory subjects.
