Medical Device Design Controls
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Industry :
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Course Description:
Design control has been a legal requirement for over 30 years, yet many firms fail to take full advantage of a controlled method for introducing new products or changing existing products costing millions of dollars and injuring both patients and health care professionals.
Why should you Attend?
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.
This webinar on 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 and warranty costs
Areas Covered:
- FDA's design regulations
- International design control requirements
- Design plans
- Verification vs. Validation
- Risk Management
- International standards
- FDA guidance documents
Who will benefit?
Highly beneficial for the designations mentioned below:
- R and D Personnel
- Design Engineers
- Validation Engineers
- Regulatory Professionals
- Marketing Managers
- QA and RA Managers
Related Technical Document 21CFR 820, ISO 13485
Target Companies: Medical Device Manufacturers
Registration Options
Speaker Details
John Chapman
Medical Device Consultant
Mr John Chapman has 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. RAB Accredited Lead Auditor Course Certificate 1996. 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
Refund Policy
Participants/Registrants for our live events, may cancel up to 72 hours prior to the start of the live session and ComplianceTrain will issue a letter of credit to be used towards any of ComplianceTrain's future events. The letter of credit will be valid for 12 months.
ComplianceTrain will process refund in cases where the event has been cancelled and is not rescheduled within 90 days from the original scheduled date of the webinar. In case if a live webinar is cancelled, participants/registrants may choose between recorded version of the course or a refund. Refunds will not be processed to participants who do not show up for the webinar. A webinar may be cancelled due to unavoidable circumstances, participants will be notified 24 hours before the scheduled start of the event. Contact us via email: admin@ComplianceTrain.com
