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Phone: 800-447-9407

RAPS Approved Webinar on

Design Control for Professionals Date: Tuesday, November 13, 2012

Time: 10:00 AM PDT | 01:00 PM EDT

Course "Design Control for Professionals" has been pre-approved by RAPS as eligible for up to 1.00 credits towards a participant's RAC recertification upon full completion.

Duration: 60 Minutes Instructor: John Chapman Location: Online Price : $245.00 (for one participant)

John Chapman Regulatory Affairs Professional,

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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. ...more

Overview: Since 1984 the FDA has identified the lack of proper design controls as one of the major reasons for device recalls. This was the reason FDA formalized the legal requirement for design controls in the Medical Device Amendments of 1996. Device experts have estimated it cost 10 times more resources to correct a poor design after it has been in manufacture than to design it right to begin with. This is in addition to the bad publicity of recalls and other regulatory action. This webinar will emphasize key portions of good design control and poor design control along with some important tools learned by the author over the last 25 years.

Areas Covered in the Session: l l l l l l l

FDA's design regulations International design control requirements Design plans Verification vs. Validation Risk Management International standards FDA guidance documents

Who Will Benefit: l l l l l l

R&D Personnel Design Engineers Validation Engineers Regulatory Professionals Marketing managers QA & RA Managers

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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 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


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Design Control for Professionals - Webinar By GlobalCompliancePanel  

Since 1984 the FDA has identified the lack of proper design controls as one of the major reasons for device recalls. This was the reason FDA...

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