This Master Validation Planning training will evaluate how to do Validation and Verification under the current changes came due to the March 2010 Mod 5 changes to the EU MDD.
Why Should You Attend:
Both the U.S. FDA and the EU's MDD require companies to be proactive in reducing product risk while increasing user benefits. But following questions comes in to picture
- Once the product and process design activities develop new or substantially changed products, how can these be verified and validated?
- Company and submission data must be more "science based". Recalls point to serious V&V shortfalls. How can these be addressed?
- What V&V planning steps are expected under the CGMPs.
- How can these consistently be executed at all plant sites?
- Where does ISO 14971, ICH Q9, and similar risk management systems come in? Across industries?
- How does the March 2010 Mod 5 changes to the EU MDD impact product validation planning?
This webinar will evaluate the climate that has resulted in this call for change, and flag areas for heightened compliance in V&V planning. It will focus on eliminating such negative "triggers", reduce "fire fighting" and identify, minimize or eliminate major systemic validation problems. It will assist the attendee to review their existing system in light of current and anticipated changes in regulatory thinking, and in approaches to implementing necessary changes.
Areas Covered in the Seminar:
- Tougher FDA V&V Expectations.
- Key Product V&V Requirements.
- Key Equipment, Process, Software and QMS / Part 11 V&V Activities.
- Growing Problem Areas.
- The EU's MDD Mod 5 Changes and V&V Planning / Documentation.
- How to Implement, Execute and Document.
- Allocation of Scarce Resources.
Who Will Benefit:
This webinar will provide valuable assistance to personnel in all regulated companies responsible for cGMP and MDD/CE-mark compliance. This information applies to primarily to personnel / companies in the Medical Device industry. However, its principles apply and can be used in other regulated industries, e.g., Pharmaceutical, Diagnostic, Biologics and Dietary Supplements. The employees who will benefit include:
- Senior management
- Regulatory Affairs
- Quality Assurance
- Production
- Engineering
- Sales and Marketing
- All personnel involved in a U.S. FDA- and/or EU ISO 13485/MDD-regulated environment
Instructor Profile:
John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 28 years experience in U.S. FDA-regulated industries. John has worked with companies from start-up o 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 published 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. John is a graduate of UCLA.
