Biopharmaceutical Good Distribution Practices Summit
Product Details
Welcome to the emerging — and risk filled — world of good distribution practice (GDP) compliance.
For example, a product may be manufactured at a foreign facility, shipped by air or ship to the US, transferred through an airport or port, loaded onto a truck, moved between 2-3 distributors all before reaching the pharmacy or patient. At any of those points, if you can’t convince regulators you have maintained security and stability controls, you could be looking at a Form 483 or other warning.
Inspectors are requiring manufacturers to prove they have adequate risk management controls in place AND provide detailed records and test results that assure temperature stability of past shipments.
The truth is, you’re in for more headaches and complications. But there’s help close at hand. FDAnews welcomes you to Washington, D.C., to learn and share with your colleagues best practices to maintain GDP compliance.
Come to Washington Monday-Wednesday, March 18-20, 2013, for the:
Biopharmaceutical Good Distribution Practices Summit
March 18 - 20, 2013
Doubletree Hotel, Bethesda, MD
It’s three days and two nights of face-to-face interchange with regulators, GDP pioneers, policymakers, risk management experts and consultants — and, not least, your fellow executives at FDA-regulated manufacturing enterprises coast to coast and around the world.
We’ve invited an array of knowledgeable GDP execs from leading drug and biotech firms to help you face — and solve — the challenges you encounter day to day. Check this list for names you may know:
- Michele Johnson, Supply Chain Advisor, Cubist Pharmaceuticals (Co-Chair)
- Gary Hutchinson, President, Modality Solutions LLC, formerly Director of Global Transportation, Amgen (Co-Chair)
- Barbara Falco, President, Barbara Falco Pharma Consulting, former QA Director at Abbott Laboratories
- Ash Patel, Associate Director, Product Security & Brand Integrity, Biogen Idec
- Rebecca Gentile, Senior Specialist, Quality, Global Vaccine & Biological Stability, Merck
- B. Brett Heavner, Partner, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
- Stephen Healy, European Sales Director, Intelsius
- Kim Egan, Founder, Saltbox Consulting, formerly Partner, Co-Chair Health Care Sector, Co-Chair,
Clinical Trials Working Group, DLA Piper LLP
Combining a mix of presentations and panel discussions — featuring regulators and industry experts — this Summit has something for everyone. Each presenter and panelist will be providing a few “take-away” solutions. After three days, you’ll leave with 50 solutions, tips and tricks to take back to your company. Anticipated Summit sessions include:
- Developing a Controlled-Environment Logistics Validation Master Plan
- Cubist Pharmaceutical Case Study: Managing a Virtual Supply Chain
- Developing a Controlled Environment Logistics Validation Master Plan
- You Are Your Brand, Your Brand Is You — Combating Counterfeiting
- Industry Update — Why Rx-360's New Initiatives Could Change The Way You Operate
- Stability Testing to Support Distribution of New Drug Products
- Maybe the World Isn’t Coming to an End, But It Sure Seems Like That on Some Days — Contingency Planning Best Practices for Biopharmaceuticals GDPs
- Cubist Pharmaceutical Case Study: Managing a Virtual Supply Chain
- Good Distribution Practice Quality Agreements — Can’t We Just All Get Along? Understanding Where Industry Has Consensus and Differences
- A Regulator Dissects Current Track-and-Trace Strategies
- Packaging As the First Line of Defense Against Counterfeiting
2013 Sponsors:
For 2013 exhibit options and sponsorship packages contact Colette McMullen, Director, Business Development at (703) 538-7642 or cmcmullen@fdanews.com