| 55 Days Left
This webinar provides a detailed overview of the recent updates to Title 21, focusing on the FDA’s transition from QSR to QMSR and its alignment with ISO 13485. Participants will gain clarity on new inspection approaches, regulatory expectations, and how these changes impact medical device and combination product companies.Strategies for developing adaptability and flexibility, managing uncertainty, enhancing problem-solving skills, and building resilience.
What will you Learn?
- Overview of Title 21 updates and regulatory changes
- QMSR framework and incorporation of ISO 13485:2016
- Transition from QSIT to the new FDA inspection model (Manual 7382.850)
- FDA’s increased focus on risk management and patient safety
- Key compliance requirements and implementation strategies
- What changes organizations must adopt—and what should not be altered
Who should attend?
- Senior management in medical device and combination product companies
- Quality Assurance (QA) and Regulatory Affairs (RA) professionals
- Product development, R&D, and engineering teams
- Manufacturing, operations, and production personnel
- Consultants and professionals involved in compliance and regulatory submissions
Speaker
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...
