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Live Webinar

on

Verification vs. Validation in Regulated Industries

Date & Time: Tuesday, August 09, 2011

10:00 AM PDT | 01:00 PM EDT

Duration: 60 Minutes

Instructor: John Chapman

Location: Online

Price : $245.00

 

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(for one participant)

Instructor Profile:

Overview:

John Chapman Regulatory Affairs Professional,

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 you should 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 Session:

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Verification & validation types Definitions Design control Process control Application Consequences of poor verification & validation Why verification & validation makes good business sense

Click here to register for this webinar

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. ...more

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Who Will Benefit: Employees who will benefit include: l

Quality & Regulatory Professionals

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Manufacturing & Design Engineers Marketing Product Managers Corporate & Operations Executives

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It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel

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Verification vs. Validation in Regulated Industries  

Attend this webinar to understand the differences and benefits of verification and validation. Learn about the risks and complications invol...

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