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,
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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Published on Oct 4, 2012
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...