Design Control for Professionals

Duration: 60 Minutes
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.
Design Control
Instructor: John Chapman
Product ID: 500390

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:
  • 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
Objectives of the Presentation:
  • FDA's design regulations
  • International design control requirements
  • Design plans
  • Verification vs. Validation
  • Risk Management
  • International standards
  • FDA guidance documents
Who can Benefit:
  • R&D Personnel
  • Design Engineers
  • Validation Engineers
  • Regulatory Professionals
  • Marketing managers
  • QA & RA Managers
Live Session - How it works
  • Username and Password will be sent to you 24 hours prior to the webinar
  • Presentation handouts in pdf formate will be mailed to you
  • Login to the session using the username and password provided to you
  • Get answer to your queries through interactive Q&A sessions via chat
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve
  • Get certification of attendance.
Recorded Session - How it works
  • A link will be provided to you upon purchase of the recorded session
  • Please click on the link to access the session
  • Presentation handouts in pdf formate will be mailed to you
  • Get certification of attendance.
$375
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
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 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 2004Fundamentals 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.

John has had specialized training and experience in FDA QSR, ISO 13485, European Medical Device Directives, ISO 9001, Canadian Medical Device Regulations, Auditing, Root Cause Analysis, Design Control, Bloodborne Pathogens, Hazardous Waste Handling, and FDA regulations. He has also presented live on-line seminars on various regulatory subjects.
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