Managing Risks in Combination Products and Drug Delivery Systems

Why Should You 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 analyhsis 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.

Areas Covered in the Webinar:

• 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:

This webinar will provide valuable assistance to all regulated companies that need a repeatable methodology, and their in-house personnel trained in cGMP and MDD/CE-marking compliance. It will discuss and provide examples of ISO- and FDA/D6ICH-compliant product risk management templates. This applies to companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

• Senior management
• Regulatory Affairs
• Quality Assurance
• Production
• R&D and Engineering
• All personnel tasked with product hazard reduction and problem solving

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 41 years experience in U.S. FDA-regulated industries, 27 years as head of his own consulting company. 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. 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, 5 chapters in the RAPS textbook on validation, conducted workshops and webinars worldwide on CGMP subjects. John is a graduate of UCLA.

Follow us :