FDAnews Announces — Risk-Based Strategies to Prevent Drug Shortages: PDA’s New TR 68 Guidance on Manufacturing and Quality Issues Webinar, July 2, 2015

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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. 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.

Risk-Based Strategies to Prevent Drug Shortages: PDA’s New TR 68 Guidance on Manufacturing and Quality Issues
**FDAnews Webinar**
July 2, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/riskbasedstrategies

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 webinar, Ms. Schniepp and Ms. Ramnarine will teach attendees the 4 most important ways to immediately stem shortages, including:

  •     How to apply a proactive risk-based model at a product level to identify drug shortage risks due to manufacturing and quality issues
  •     Best practices to write and enforce the kind of plans prescribed in TR 68 using examples and standard templates
  •     Conducting internal audits to determine if the current controls are properly designed to address drug shortage risks — and if not, what the next move is
  •     They’ll challenge attendees to think creatively and in a risk-based manner about other practical ideas that can be leveraged beyond conventional solutions. Tips include:

o    Collaboration with health authorities to expedite post-approval changes
o    Short-term use of an alternate facility
o    Activating short-term supply from alternate sources during emergencies

Meet the 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.

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.

Who Will Benefit:

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

Conference Details:
Risk-Based Strategies to Prevent Drug Shortages: PDA’s New TR 68 Guidance on Manufacturing and Quality Issues
**FDAnews Webinar**
July 2, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/riskbasedstrategies

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/riskbasedstrategies
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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