Webinar – FDA Incentivizing Organizational Maturity to Drive Product Quality

Medical Device Week Presented by Lachman Consultants - FDA Incentivizing Organizational Maturity to Drive Product Quality

This webinar is offered for FREE by Lachman Consultant Services, Inc. FDA Incentivizing Organizational Maturity to Drive Product Quality. Register Here!

WHAT YOU’LL LEARN ABOUT DURING THIS WEBINAR:

• Centers for Devices (CDRH) Case for Quality Voluntary Improvement Program (CfQ VIP) and Centers for Drug (CDER) Quality Management Maturity (QMM) are incentive programs which the FDA is using to drive industry standards for enhanced quality.
• From regulatory relief to pilots evaluating mandatory programs, how and why the FDA is looking towards organizational excellence as the mechanism to improve patient safety while accelerating approvals.

ABOUT THE INSTRUCTOR:

Vizma Carver, M.S., Senior Associate in the Compliance Practice at Lachman Consultants, has more than twenty-five years of experience directing world-wide teams in the development of first-generation healthcare, biotech, and national security solutions. She has led the Department of Defense (DoD) Military Health System (MHS) technical stack integration, implementation and security of global longitudinal Electronic Medical Record and clinical registries (AHLTA), and Health Information Exchange system with the Veterans Health Affairs VistA System (CHDR, BHIE-AHLTA).

With a career that began as a stem cell bench researcher and biotech software expert, she has also led local health and human services providers, to include the first local home health automation system in the United States and has served on Washington State Governors Heroin Task Force.

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, Biologics, Device, and Related Life Science Industries.