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The ink is barely dry on the draft MNP guidance, and the pressure is already on many drug and biologics manufacturers to develop emergency plans to meet FDA requirements. Here’s how to get up to speed — fast.
Ensuring Supply Continuity for Medically Necessary Drug Products
Your Game Plan for Compliance and Supply Chain Assurance
An FDAnews Webinar
Tuesday, April 20, 2010 · 1:30 p.m. – 3:00 p.m. EDT
In January 2010, the FDA released a draft guidance that requires manufacturers of medically necessary drug products (MNPs) to have specific emergency plans — and corresponding SOPs — for each of their facilities in case of supply chain disasters or high absenteeism.
The guidance says emergency plans should be developed, written, reviewed and approved within a site’s change control quality system under the requirements of 21 CFR 211.100 and 211.160. In addition, a broader plan should address the potential for shifting operations, resources or personnel across multiple sites.
What exactly is a medically necessary product? The FDA calls a product medically necessary if it falls into one of four categories:
Because the guidance provides only a general outline and simple overview of the steps required to implement the plans, manufacturers are left with the difficult responsibility of adapting the guidance for their facilities without any details of how to go about doing it.
Fortunately, help is at hand.
Mark your calendar now for this 90-minute webinar on Tuesday, April 20. It’s all you need to get up to speed on the FDA guidance, “Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products.”
Your guide through the draft guidance is Jack Garvey, a leading lawyer and consultant on FDA compliance matters. In 90 information-packed minutes, he’ll spell out precisely how you can adapt its provisions to fit your facilities. Here’s just a taste of what he will cover:
This is a workshop you attend without leaving your workplace. Simply make sure you’re in front of a screen at the appointed time. Have questions? Submit them via email for answers by the time the session ends.
Everyone in your organization with a role in medically necessary drug products deserves to take part in this event — and they can do so, at a cost that won’t break the budget. You pay a single low registration fee per facility, regardless of how many participate.
Don’t let this latest FDA draft guidance trip you up. Turn to an expert to learn what you — and your staff — need to know. Sign up today.
Who Will Benefit
Meet Your Instructor
John C. “Jack” Garvey is the founder of Compliance Architects. A leading FDA regulatory, compliance and operations executive with more than 25 years of experience developing and leading quality, regulatory and compliance initiatives, Mr. Garvey focuses on compliance and quality strategy development and deployment for leading life-science companies. A dual background in law and engineering gives his clients an advantage in resolving complex regulatory, quality and compliance issues.
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Choose between the Audio CD and transcript or listening in on the Encore presentation:
- Audio CD and Transcript Only: $327 (plus shipping and handling)
You’ll receive an audio CD and written transcript of the entire 90-minute webinar, including the Q&A period, and all presentation materials. Delivery is app. four weeks after the session.
- 24/7 ENCORE™ Audio Presentation: $327
You’ll have access to one dial-in for an archived recording of the entire 90-minute webinar, including the Q&A period, for unlimited participants. You can dial in any time of day or night for three weeks, from April 26 – May 14, 2010. You’ll also receive all presentation materials.
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