Design Control for Professionals

Instructor: John Chapman
Product ID: 701360
Training Level: Intermediate
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542


Read Frequently Asked Questions

This training program will focus on the consequences of poor design control, Failure Modes Effects Analysis (FMEA), design control segments, and more. 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 costs 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 derived by the instructor over the last 30 years.

Learning Objectives:

  • Design Planning through to Design Transfer
  • Regulatory Requirements
  • Risk Management Tools
  • Design Control Tools
  • Definitions
  • Benefits of Good Design Control

Areas Covered in the Webinar:

  • Regulatory Requirements (FDA, Canada, Europe and Others)
  • Consequences of Poor Design Control
  • FMEA (Failure Modes Effects Analysis)
  • Design Control Segments
  • Risk Management
  • Verification and Validation

Who Will Benefit:

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

Instructor Profile:

An independent QMS consultant, John Chapman, BS, MBA, RAC has over 35 years medical device QMS (Quality Management Systems) experience and over 20 years’ experience with the European Union’s medical device directive, 93/42/EEC. Mr. Chapman 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 received his RAB Accredited Lead Auditor Course Certificate in 1996.

Mr. Chapman 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. He has also presented live online seminars on various regulatory and quality system subjects.

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