Verification vs. Validation in Regulated Industries


Wednesday, March 6, 2019   |   10:00 AM PST | 01:00 PM EST   |   Duration: 60 Minutes          

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  Duration: 60 Minutes  

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In this webinar you will learn How to figure out statistical requirement for Verification and Validation, Also you will learn how to identify what the "system" will do -capability of the product, define user needs and defined operating conditions, The webinar answers many practical questions such as how-to do it etc.

John Chapman   Product Id : 502379
  Instructor : John Chapman

  More Trainings by this Expert


Overview:

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 13485:2016 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.

This presentation will define and explain the differences (& similarities) in these terms and how they apply to regulated industries as well as the consequences of poor adherence to these principles.

Why should you Attend: This webinar on verification vs. validation will help you to understand the differences between, and benefits of, verification and validation in both design and process operations in regulated industries.

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

Areas Covered in the Session:

  • Verification & Validation Types
  • Definitions
  • Design Control
  • Process Control
  • Application
  • Consequences of Poor Verification & Validation
  • Why Verification & Validation makes good Business Sense

Who Will Benefit:
  • Quality & Regulatory Professionals
  • Manufacturing & Design Engineers
  • Marketing Product Managers
  • Corporate & Operations Executives


Speaker Profile
John Chapman, BS, MBA, RAC has over 35 years medical device regulatory & compliance 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. 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. John has participated in several FDA remediation projects involving non-compliance with all QMS sub-systems. 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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