This Design Control training 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.
Why should you Attend:
- A sound design control system will help avoid:
- Recalls resulting from improper design
- Problems from improper design control resulting in loss of CE marking
- Class action lawsuits for shipping poorly designed devices
- Expensive post market repairs & warranty costs
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 seminar:
- FDA's design regulations.
- International design control requirements.
- Design plans.
- Verification vs. Validation.
- Risk Management.
- International standards.
- FDA guidance documents.
Who will benefit:
- R&D Personnel
- Design Engineers
- Validation Engineers
- Regulatory Professionals
- Marketing managers
- QA & RA Managers
Instructor Profile:
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.
