Watch now
Fill in your details to watch the webinar.
Back to the Future: How FDA’s Quality Management Maturity Program can help you build a resilient future for patients
Whilst the FDA’s Quality Management Maturity Program (QMM) is relatively new, the tenants of the program have deep roots in the evolution of Quality Systems over the past fifty years! Quality pioneers like Demming and Juran created the foundation by stressing the criticality of management responsibility, process improvement, and the use of statistical tools.
Many equally impactful contemporaries followed and contributed to what is today a rich knowledge base of best practices in quality management. These practices, when followed, ensure not just compliance but reliable and predictable processes which is at the heart of the QMM .
Even before the pandemic, FDA identified drug shortages that were a direct result of unreliable manufacturing processes, that while completely compliant, could not deliver to meet the needs of patients. FDA has subsequently partnered with multiple stakeholders to develop the QMM in an effort to ensure patients, families and other stakeholders can count on the availability of life saving and life sustaining medicines. In this webinar, we will go Back to the Future while exploring FDA’s Quality Management Maturity Program.
Key takeaways
- Understanding and exploring the foundation of the four program pillars
- Understanding importance of the 6 Ps in the supply chain
- Linkage to global quality systems standards including the parallels to Medical Devices
- Explore options for assessing your organization’s readiness to participate in the QMM
- Explore how Ideagen quality management and validation solutions can better support your organization on the journey to quality management maturity
Lindsey is dedicated to helping organizations, of any size, to address challenges regarding quality, compliance, or regulatory affairs. He specializes in providing solutions that drive for a culture of quality and compliance, while optimizing the size and complexity of compliance systems. All with a clear focus to meet the specific needs of our client’s, their products, and/or services.
As regulatory affairs executive consultant, Lindsey brings over 40 years of broad quality and regulatory affairs experience. His career has spanned multiple industries including automotive, aerospace, drug, biologic, and multiple medical device companies (critical care, in vitro diagnostic, and companion diagnostic). This includes numerous start-up scenarios requiring quality systems design and implementation of design controls required for compliant product development.
Prior to joining CompliancePath, Lindsey held various leadership positions in healthcare companies, both large and small, including Abbott Laboratories, Life Technologies, Digene, Wellstat Biologics, and most recently retiring from QIAGEN as Vice President, head of global regulatory affairs.
In addition to supporting AAMI as a lead trainer (i.e. QMS, Design Controls, and Validation), he has been actively involved in AdvaMed and while at QIAGEN sponsored the FDA’s experiential learning program. He is also an ASQ member, ASQ Certified quality engineer, as well as a certified Birkman® consultant.