John Chapman
Instructor John Chapman
Product Id 600531
Duration 60 Minutes  
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

Verification vs. Validation in Regulated Industries

Overview:

Attend this webinar to understand the differences and benefits of verification and validation.

Learn about the risks and complications involved with the application of sound verification and validation principles.

Why Should You Attend: 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: Employees who will benefit include:
  • Quality & Regulatory Professionals
  • Manufacturing & Design Engineers
  • Marketing Product Managers
  • Corporate & Operations Executives

Speaker Profile
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 been 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.

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