Webinar

FDA’s Quality Management Program


This FDAnews virtual summit webinar can empower your team to develop a world-class QMS by implementing the essentials of quality management maturity (QMM) metrics. Additionally, you’ll understand more about the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH).

 

Optimizing Your Quality Management Program for FDA compliance

 

Quality Management

Sessions will clearly demonstrate the importance of quality control management to standardize efficient behaviors via meaningful metrics. Finally, detail on how to ensure your quality culture is a high-powered functional tool.

 

Achieve True Quality Culture and Stay Compliant

Quality SummitYou’ll come away with the knowledge and know-how to create a world-class QMS:

  • What the FDA looks for in a Quality Management System
  • How to ensure your continuous improvement initiative addresses GMP and other regulatory requirements
  • Planning quality management and meeting FDA standards expectations resulting from the COVID-19 experience
  • How to ensure your quality management process meets the quality expectation of consumers
  • The importance of creating quality milestones and incentives that are patient-focused and transparent
  • Why total quality control gives you a competitive advantage over your competitors and credibility with the FDA
  • How to develop QMM metrics that go beyond mere numbers and actually measure quality
  • The importance of your document control system to standardize efficient behaviors via quality metrics
  • How to meet supply chain challenges and evaluate vendors to ensure quality service
  • Training you data quality manager about data integrity, risk management, and quality management
  • Establishing a culture of quality throughout your QMS system and organization

 

About FDA News

Since 1972, WCG FDAnews has been dedicated to providing executives in the life science community with top-notch domestic and international regulatory, legislative, and business news. More than 200,000 pharmaceutical and medical device professionals rely on our newsletters, databases, books, special reports, webinars, and conferences to stay in compliance with ever-changing regulations on quality, manufacturing, safety, and inspection issues.

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    Presenters

    Steven J. Lynn, MS

    Executive Principal Consultant, Pharma and Biologics

    Steve has over twenty (20) years of quality and regulatory compliance-related experience in the pharmaceutical, biopharmaceutical, medical device, blood, plasma, and tissue industries. He is an expert in Current Good Manufacturing Practices (CGMP) compliance-related matters and has significant experience with other GxP quality compliance and regulatory issues. Steve served in executive leadership roles with global accountability in both the private sector, as well as at the US FDA. In the private sector, Steve was an executive at two large multi-national corporations and also worked as a consultant for multiple large, mid-sized, and small clients.