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.
Course Content
- 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
Course Provider
John E. Lincoln,
Principal Consultant ,
J. E. Lincoln and Associates LLCJohn 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 and 20 years as a full-time consultant. He 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 so+E6ftware validations, ISO 14971 product risk management files / reports, design control / design history files, and technical files. He's held positions in manufacturing engineering, QA, QAE, regulatory affairs, to the level of director and VP (R&D). In addition, Mr. Lincoln has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CGMP subjects. He is a graduate of UCLA.
Who Should Attend
- Senior Management
- Regulatory Affairs
- Quality Assurance
- Production
- R&D and Engineering
- All Personnel Tasked with product hazard Reduction and Problem-Solving
