The FDA is focused on evolving the medical device industry, ensuring safety, and enhancing quality among all manufacturers. Their goals are being met in part through two incentive programs – the Center for Devices and Radiological Health’s (CDRH) Case for Quality Voluntary Improvement Program (CFQ VIP) and the Center for Drug and Evaluation Research’s (CDER) Quality Management Maturity (QMM) Program.
“These voluntary programs are critical in driving the industry forward,” explains Vizma Carver, M.S., Senior Associate in the Compliance Practice at Lachman Consultant Services, Inc. (Lachman Consultants). “From regulatory relief to pilots evaluating mandatory programs, the FDA is leveraging organizational excellence as a mechanism to improve patient safety, while accelerating approvals.” Both programs offer opportunities to reduce certain regulatory requirements for manufacturers demonstrating the highest safety and quality standards.
To help medical device manufacturers better understand and participate in these incentives, Lachman Consultants will present “FDA Incentivizing Organizational Maturity to Drive Product Quality”, a free webinar hosted by Ms. Carver. The webinar, which is part of Lachman Consultant’s Medical Device Week, takes place on Wednesday, February 3, 2021, from 11:00 am to 12:30 pm EST. The event includes an overview, requirements, best practices, and top strategies for successfully navigating these programs.
Ms. Carver has more than 25 years of experience directing worldwide teams in developing first-generation healthcare, biotech, and national security solutions. At the FDA, Carver served as a CDRH Entrepreneur-in-Residence and co-led the Medical Device Innovation Consortium Case-for-Quality Maturity Model. She was also named Expert Digital Health Advisor for the FDA’s Digital Health Unit.
Lachman Consultant’s Medical Device Week will also feature original content on The Lachman Blog, with daily posts covering important medical device issues and topics.
Register today for “FDA Incentivizing Organizational Maturity to Drive Product Quality.”
WEDNESDAY, FEBRUARY 3
11AM – 12:30PM EST
How the FDA is Incentivizing
Organizational Maturity to
Drive Product Quality
Learn about FDA programs from one of FDA’s program co-founders
– MONDAY, FEBRUARY 1 –
Using AI to Modernize Diagnostics Tools
Discover the FDA position on AI to modernize diagnostic tools and more
– TUESDAY, FEBRUARY 2 –
Medical Device and Drug
Development and Manufacturing
Data Governance in the Information Age
The pitfalls to implementing Enterprise Resource Planning (ERP) and other topics
– THURSDAY, FEBRUARY 4 –
Don’t Reinvent the Wheel:
Use your SDLC infrastructure to manage product change control
What is really lost when SDLC is seen as a paper exercise and more
– FRIDAY, FEBRUARY 5 –
Cybersecurity as the Offensive to protect your assets Includes understanding the Homeland Security initiative with the FDA