“From regulatory relief to pilots evaluating mandatory programs, the FDA is leveraging organizational excellence as a mechanism to improve patient safety, while accelerating approvals.” - Vizma Carver, M.S., Senior Associate in the Compliance Practice
WESTBURY, N.Y. (PRWEB) January 22, 2021
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 Consultants’ 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 also was named Expert Digital Health Advisor for the FDA’s Digital Health Unit.
Lachman Consultants’ Medical Device Week will also feature original content on The Lachman Blog, with daily posts covering important medical device issues and topics. To sign up for Medical Device Week updates, subscribe to the Lachman Consultants blog at: https://www.lachmanconsultants.com/blog/
To register for “FDA Incentivizing Organizational Maturity to Drive Product Quality,” please visit: https://register.gotowebinar.com/register/3167928707438266637
ABOUT LACHMAN CONSULTANTS
Founded in 1978, Lachman Consultants maintains three practice groups: Compliance, Regulatory Affairs, and Science and Technology. Each practice offers industry-leading experience and expertise in its area of focus. Lachman Consultants serves emerging-to-enterprise organizations on a worldwide basis in the Pharmaceutical, Biotechnology, Biologics, Device, and Related Life Science Industries. Lachman Consultants delivers highly effective and proven solutions that include FDA-Related Services, Audits, Quality Assurance & Controls, Scientific and Technical Assistance, Systems Evaluation, and Training, which have been shown to consistently exceed client requirements and expectations.
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Ilena Della Ventura