Verification vs. Validation in Regulated Industries

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Live Webinar

on

Verification vs. Validation in Regulated Industries

Date & Time: Thursday, March 1, 2012

10:00 AM PST | 01:00 PM EST

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 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 Session: l l l l l l l

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 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. ...more

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Who Will Benefit: l l l l

Quality & Regulatory Professionals Manufacturing & Design Engineers Marketing Product Managers Corporate & Operations Executives

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

About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel www.globalcompliancepanel.com


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