There will be added focus on the special needs of combination products. Also increased focus on the often high-risk considerations of drug delivery systems, with the recent increased concern posed by potential cybersecurity vulnerabilities.

This Seminar will expand this tool into R&D design control, training, marketing, validation, root cause analysis, CAPA / failure investigations, GMP auditing, and liability reduction. Regular use of a few simple but powerful tools in a Product Risk Management File and Review template can contribute greatly to the reduction of product liability, company-wide cost reduction efforts, less chance of recalls, and an improved bottom line.

Why We Should Attend

Both the U.S. FDA and the EU's MDR require product risk management as part of virtually all regulatory compliance efforts. Combination products can add to risk exponentially. And Drug Delivery Systems are many times extremely high risk, requiring even more complex analyses Companies must be proactive in reducing product risk. while increasing user benefits. Companies are still not developing the required tools nor using them in all regulated / CGMP activities, especially the newer expanded requirements of the 2019 version of ISO 14971, When used, companies have often not provided the full documentation to allay investigators' / auditors' concerns. Existing risk documents are not being used to their full potential.


  • Key requirements of ISO 14971 and ICH Q9
  • The definition of "risk" to avoid an automatic FDA Warning Letter
  • Suggested Report formats to meet both US FDA and EU MDR requirements
  • Expected sources of information for evaluation and inclusion
  • How to compile
  • A key member of the Risk Management Team
  • When to involve the team
  • How to complete, document, and control as a 'living' document
  • An often-neglected safety feature
  • QMS integration - a recent emphasis
  • Incorporation into the design and development (R&D) phase

Who Will Benefit

  • Senior Management
  • Regulatory Affairs
  • Quality Assurance
  • Production
  • R&D and Engineering
  • All Personnel Tasked with product hazard Reduction and Problem-Solving

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Faculty John E. Lincoln

Principal of J. E. Lincoln and Associates LLC

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 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 QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.


RAPS - This course has been pre-approved by RAPS as eligible for up to 4.0 credits towards a participant's RAC recertification upon full completion.

World Compliance Seminars (WCS) is a Regulatory Affairs Professional Society (RAPS) RA Professional Development Portal provider. World Compliance Seminars is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs. World Compliance Seminars has agreed to follow RAPS-established operational and educational criteria