RAPS pre-approved webinar on

GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organizeaRAPS pre-approved webinar on November 13.

Wilmington, DE (prHWY.com) September 21, 2012 - Description:For nearly three decades now, the number of recalls that the FDA has been making of medical devices purely for lack of design control has steadily gone up. This is a major reason for device recall, and the reason for which the FDA formalized the legal requirement for design controls in the Medical Device Amendments of 1996.

Why is it important to have a proper design control in place at the time of manufacture? Because it costs ten times as much to correct an improper design than to manufacture it rightly the first time round. Other penalties include having to face class action and losing the CE marking for shipping badly designed medical devices. Add to all these the inestimable cost that bad publicity brings into this exercise, and the need for getting design controls right cannot be overemphasized.
This webinar will take participants through the proper way of putting design control in place. The presenter will bring to bear some classic examples of good design control and bad design control that he has observed in the many years of being an industry expert. Mr. Chapman will cover the following areas in this session:

o FDA's design regulations
o International design control requirements
o Design plans
o Verification vs. Validation
o Risk Management
o International standards
o FDA guidance documents
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When:November 13,10:00 AM PDT | 01:00 PM EDT
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By whom:
John Chapman, BS, MBA, RAC has been in the medical device regulatory industry for over 30 years, over 10 of which have been spent with the European Union's medical device directive, 93/42/EEC. Leading two device companies to ISO quality system certification and CE marking is one of the highpoints of his highly successful career.
In the course of performing regulatory due diligence on over a dozen acquisitions in the past 12 years, John has been exposed to numerous Quality Systems, including consent decrees. This work has also acquainted him with 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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For whom:
The webinar will benefit
o R&D Personnel
o Design Engineers
o Validation Engineers
o Regulatory Professionals
o Marketing managers
o QA & RA Managers
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Duration:60 minutes
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To enroll for this webinar, contact
webinars@globalcompliancepanel.com
Phone: 800-447-9407

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Tag Words: ce marking, regulatory action, medical device amendments, online training

Categories: Health

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GlobalCompliancePanel

Phone: 800-447-9407
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webinars@globalcompliancepanel.com
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