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Verification vs. Validation in Regulated Industries - Webinar

  • ID: 4899763
  • Webinar
  • January 2019
  • Region: Global
  • 90 Minutes
  • Compliance Online
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Why Should You Attend:

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 by attending this training.

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 Webinar:

Verification & validation types.
Definitions.
Design control.
Process control.
Application.
Consequences of poor verification & validation.
Why verification & validation makes good business sense?
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John Chapman, BS, MBA, RAC has over 35 years’ medical device regulatory experience and over 15 years’ experience with the European Union’s medical device directive, 93/42/EEC. Mr. Chapman has led two device companies to ISO quality system certification and CE marking. He has performed regulatory due diligence for 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.

Mr. Chapman 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 online seminars on various regulatory and quality system subjects.
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