Design Control and Risk Management For Combination Products
Design Control and Risk Management For Combination Products

Course Description

The course has been developed to introduce you to the international requirements for design control and risk management of combination products. There is a particular emphasis on drug – device combinations and drug delivery devices that are regulated as combination products or drug-device combinations in Europe requiring the notified body opinion (NBOp). We assume no prior knowledge of design control or risk management as many of the attendees will be more familiar with pharmaceutical regulation and cGMP. Our course is based upon worked examples facilitated by the tutor but also enables participants to discuss their products (without breaching intellectual property restrictions!). The sessions are a blend of regulatory requirements discussing in particular ISO13485:2016 section 7.1 and 7.3 in particular but also CFR21 Part 4 and CFR21 Part 820.30.
  • Risk management and design control fundamentals
  • Standards and regulations
  • Usability engineering
  • Design Controls Requirements
  • Design Changes
  • Post-approval
  • Risk Analysis, Evaluation And Controls
  • Critically evaluate product design to ensure compliance with essential safety and performance requirements
  • Understand the regulatory requirements for drug-device, device-drug combinations
  • Understand design control expectations
  • Identify requirements of key International Standards and regulatory requirements relative to risk management and design control
  • Understand the importance of human factors and useability engineering
  • Identify how risk management affects quality management system practices

Design Control and Risk Management For Combination Products (US)

24 - 26 September 2024, Live Online Training
€1.850,00
James Pink

James Pink has over 20 years of experience in medical devices including 10 years as a lead auditor for European Notified Body. James is a contributor to several medical device standards committees including ISO13485, ISO 14971 and various product-related standards.

START TIMES

12:00 PM New York time

9:00 AM Los Angeles time

5:00 PM London time

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Course Description

The course has been developed to introduce you to the international requirements for design control and risk management of combination products. There is a particular emphasis on drug – device combinations and drug delivery devices that are regulated as combination products or drug-device combinations in Europe requiring the notified body opinion (NBOp). We assume no prior knowledge of design control or risk management as many of the attendees will be more familiar with pharmaceutical regulation and cGMP. Our course is based upon worked examples facilitated by the tutor but also enables participants to discuss their products (without breaching intellectual property restrictions!). The sessions are a blend of regulatory requirements discussing in particular ISO13485:2016 section 7.1 and 7.3 in particular but also CFR21 Part 4 and CFR21 Part 820.30.
  • Risk management and design control fundamentals
  • Standards and regulations
  • Usability engineering
  • Design Controls Requirements
  • Design Changes
  • Post-approval
  • Risk Analysis, Evaluation And Controls
  • Critically evaluate product design to ensure compliance with essential safety and performance requirements
  • Understand the regulatory requirements for drug-device, device-drug combinations
  • Understand design control expectations
  • Identify requirements of key International Standards and regulatory requirements relative to risk management and design control
  • Understand the importance of human factors and useability engineering
  • Identify how risk management affects quality management system practices

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

Design Control and Risk Management For Combination Products (US)

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Medical-Devices-Certificate-Course

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