Drug Shortages and cGMP/Quality – Webinar Recording/Transcript
Drug Shortages and cGMP/Quality: An Interview with CDER Deputy Director Dr. Douglas C. Throckmorton
How are quality issues impacting drug shortages? What can you do about it? Hear straight from the FDA.
Douglas C. Throckmorton, MD, Center for Drug Evaluation and Research (CDER) Deputy Director for Regulatory Programs, will be interviewed on the topic by Peter Pitts, former FDA Associate Commissioner and current president of the Center for Medicine in the Public Interest.
Up for discussion is one of the root causes of drug shortages — the market not recognizing and rewarding manufacturers for mature quality systems. How will CDER approach the challenges in assessing quality management maturity; the lack of transparency across the supply chain; and the lack of market reinforcement of effective quality management maturity?
Dr. Throckmorton will also discuss CDER’s next steps regarding drug shortages and pharmaceutical current good manufacturing practices (cGMP)/quality. Discover how these two interrelated issues facing CDER relate to your quality and drug shortages challenges in 2020 and beyond.
There is a distinct connection between drug shortages and pharmaceutical cGMP/quality: quality issues account for 64% of drug shortages, with manufacturing issues accounting for 37%. These two issues were addressed in FDA’s recent report, Drug Shortages: Root Causes and Potential Solutions. The report identifies causes and offers recommendations to help prevent and mitigate drug shortages.
The FDA will recognize and reward quality manufacturing to provide companies an incentive to achieve greater reliability in production — reducing the risk of supply disruptions and shortages. Dr. Throckmorton and Mr. Pitts will reveal the actions you can take to prevent drug shortages by promoting and sustaining quality manufacturing.
- How the FDA is implementing its landmark report on the topic — Drug Shortages: Root Causes and Potential Solutions
- How the FDA is interacting with drug manufacturers to alleviate the drug shortage situation
- The pivotal role manufacturers can play in assessing potential threats to quality and in taking proactive remediation in areas such as facility redundancy
- The crucial role that data and transparency play in quality issues affecting drug shortages
- How the FDA is currently administering the requirements to be followed by drug manufacturers for good manufacturing practices in manufacturing, processing, packaging and holding of drugs under 21 CFR Part 210
- How drug manufacturers can stay in compliance with FDA regulations on cGMP quality
Bolster your pharmaceutical cGMP/quality and avoid drug shortages. Don’t miss this incredible opportunity to hear directly from CDER’s Deputy Director and a former FDA Associate Commissioner on two of the agency’s most important 2020 initiatives.
Meet Your Presenters
Douglas C. Throckmorton, M.D. is CDER’s Deputy Director for Regulatory Programs at FDA. He shares the responsibility for overseeing the regulation of research, development, manufacture and marketing of prescription, over-the-counter and generic drugs in the U.S. Dr. Throckmorton received his medical degree from the University of Nebraska Medical School and completed his residency and fellowship at Case Western Reserve University and Yale University, respectively. Prior to coming to FDA in 1997, he conducted basic science research and practiced medicine at the Medical College of Georgia, Augusta, Georgia and Augusta Veterans Administration Hospital. He is a board-certified physician.
Peter Pitts is a former Associate Commissioner at the Food and Drug Administration and current President of the Center for Medicine in the Public Interest. He is also Visiting Professor at the University of Paris Descartes Medical School and has served as Associate Editor, Therapeutic Innovation & Regulatory Science and on the Board of Advisors of the Digital Health Council.
Who Will Benefit
- Regulatory Specialists
- Compliance Specialists
- Quality Specialists
- Vice Presidents of Strategic Development