Risk-Based Strategies to Prevent Drug Shortages - Webinar CD/Transcript

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Risk-Based Strategies To Prevent Drug Shortages: PDA’s New TR 68 Guidance on Manufacturing and Quality Issues

Drug shortages, especially for the supply of critical medicines, have emerged as an issue that affects patients worldwide and has drawn the attention of international regulators.

In February, the Parenteral Drug Association (PDA) released Technical Report 68 (TR 68): Risk-Based Approach for Prevention and Management of Drug Shortages, which describes a risk-based model — at a product level — to identify drug shortage risks due to manufacturing and quality issues. Plus, it establishes a Drug Shortage Risk Register and a Drug Shortage Prevention and Response Plan — a holistic framework which includes simple templates.

Get an inside look at TR 68 from Emma Ramnarine of Roche Pharma, one of the report’s authors, and Susan Schniepp, a 30-year industry veteran who has held numerous positions in the PDA.

TR 68 has been reviewed by FDA, EMA and other regulatory agencies and has quickly gained acceptance as globally significant in the effort to reduce drug shortages.

In this presentation, Ms. Schniepp and Ms. Ramnarine will teach you the 4 most important ways to immediately stem shortages, including:

  1. How to apply a proactive risk-based model at a product level to identify drug shortage risks due to manufacturing and quality issues
  2. Best practices to write and enforce the kind of plans prescribed in TR 68 using examples and standard templates
  3. Conducting internal audits to determine if your current controls are properly designed to address drug shortage risks — and if not, what your next move is
  4. They’ll challenge you to think creatively and in a risk-based manner about other practical ideas that can be leveraged beyond conventional solutions. Tips include:
    • Collaboration with health authorities to expedite post-approval changes
    • Short-term use of an alternate facility
    • Activating short-term supply from alternate sources during emergencies

This course will be of benefit:

  • QA/QC professionals
  • Manufacturing and operations mangers
  • Supply chain and logistics professionals
  • Regulatory affairs
  • Governmental affairs
  • Risk management specialists
  • Distribution agents

Meet Your Presenters

Emma Ramnarine, Sr. Director, Head of Global Biologics QC Network, Roche Pharma
Emma is accountable for the biologics QC network strategy including lifecycle management of methods, analytical technology and analytical controls systems, stability program management, raw materials management and adventitious agent testing. Prior to this Emma was Head of Quality Risk Management and led the design, deployment and governance of a harmonized QRM program at Roche Pharma. Emma is currently co-leading PDA’s Task Force on Drug Shortages. Before joining Genentech in 2005, Emma worked at Guidant Corporation and ALZA/Johnson & Johnson. Emma has an M.S. in Pharmaceutical Sciences from University of Connecticut, an M.S. in Medicinal & Pharmaceutical Chemistry and a B.S. in Pharmacy, both from the University of Indore, India.

Susan Schniepp, Chair of Regulatory Affairs / Quality Advisory Board, Parenteral Drug Association
Susan Schniepp has over 30 years of industry experience in quality control and quality assurance. During her career she has had responsibilities for complaints, labeling, investigations, compendial affairs and other quality systems. Susan is an active member of PDA and is on the Board of Directors.  In addition, Susan is also co-chair of the Regulatory Affairs/Quality and Membership Advisory boards and has presented at many PDA venues. In 2009 Susan was the recipient of the PDA Gordon R. Personeus Award. Susan was also Chair of a USP Expert Committee from 2005-2010.