Design Control, Risk Management and Use / Human Factors Engineering

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Schedule Tuesday, September 20, 2022 || 10:00 AM PDT | 01:00 PM EDT
Duration 90 Mins
Level Basic & Intermediate
Webinar ID IQW22I0907

  • The 10 elements of Design Control in 21 CFR 820.30, the US FDA’s Device CGMPs
  • The 10 elements of Design and Development Planning in ISO 13485:2016 7.3 in the EU
  • Device Risk Management and the File per ISO 14971:2022
  • 9 Stages of Use / Human Factors Engineering under IEC 6266-1.  
  • Combining all three in R&D and subsequent device changes.

Overview of the webinar

The U.S. FDA has required Design Control, 21 CFR 820.30 since 1996-97 as part of new product R&D.  The ISO 13485:2016 7.3 requires Design and Development Planning.  Both are the same, requiring the same 10 steps. Both centers around change control to minimize defective designs getting to patients/users.

The FDA and ISO have stated that the use of a medical device or pharmaceuticals entails some degree of risk.  In fact, any medical procedure/intervention does.  A manufacturer is responsible to identify those risks, especially in the R&D phase, and take reasonable steps to mitigate them as far as practical and given the ‘state of the art’ at the time.  ISO 14971 and ICH Q9 provide accepted methodologies by which to perform and document such an analysis and are accepted by the FDA.  The latest change in ISO 14971:2019 will also be considered and discussed, including its expansion to include a company's entire QMS.

Also, a part of R&D and design control is human factors or use engineering, defined in 9 stages in IEC 62366-1, with guidance in application in IEC/TR 62366-2.  UE / HR is not required in all cases but in many.  It centers around the device’s “interface”, and its goal is to make product use mistake-proof and intuitive, hence safe with minimal user errors.

All three must be accomplished simultaneously in the R&D environment.  All these points are addressed in this webinar as an overview of the requirements

Who should attend?

  • Senior management in Devices, and Combination Products 
  • QA
  • RA
  • R&D
  • Engineering
  • Production
  • Operations
  • Marketing

Why should you attend?

The U.S. FDA has required Design Control, 21 CFR 820.30 since 1996-97 as part of new product R&D.  The ISO 13485:2016 7.3 requires Design and Development Planning. 

The use of a medical device or pharmaceuticals entails some degree of risk.  In fact, any medical procedure/intervention does.  A manufacturer is responsible to identify those risks and take reasonable steps to mitigate them as far as practical and given the ‘state of the art’ at the time.  ISO 14971 and ICH Q9 provide accepted methodologies by which to perform and document such an analysis and meets both US FDA and EU MDR requirements.

Also a part of R&D and design control is human factors or use engineering, defined in 9 stages in IEC 62366-1.  It centers around the device’s “interface”, and its goal to make products safer.

And all three must be accomplished simultaneously in the R&D environment.  

Faculty - Mr.John E. Lincoln

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 33 years experience in U.S. FDA-regulated industries, 19 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan.  He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.  He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).  In addition, John has prior experience in military, government, electronics, and aerospace.  He has ptublished numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.

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