Ensuring Supply Continuity for Medically Necessary Drug Products

Jack Garvey |

THE FOLLOWING POST IS FROM FDANEWS.  For additional information, please see:

Ensuring Supply Continuity for Medically Necessary Drug Products

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

Register Today

In January 2010, the FDA released a draft guidance that requires manufacturers of medically necessary drug products (MNPs) to have specific emergency plans — and corresponding SOPs — for each of their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:

  1. Where the company is the sole source of the drug or the drug supports a  significant share of the U.S. market
  2. Antiviral drugs that may be needed during a pandemic
  3. Drug products for conditions such as diabetes, high blood pressure, congestive  heart failure, asthma and cancer
  4. Products that are especially vulnerable to shortage because of typically low inventory levels in the supply chain

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Your guide through the draft guidance is Jack Garvey, a leading lawyer and consultant on FDA compliance matters.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:

  • The definition of medically necessary product (MNP)
  • The FDA’s Drug Shortage Program — what it is, what are its implications
  • The 7 main elements of the MNP draft guidance
  • Which elements are “requirements-oriented” and which are “goal-oriented”
  • What the FDA notice provisions are
  • How and where to direct notice to the FDA in event of a plan activation
  • Resolving conflicts between guidance provisions and business continuity planning
  • Developing a plan: Suggested elements and components
  • Testing the plan for effectiveness: What the FDA expects
  • And much more

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.

Register Now

Who Will Benefit

  • Operations
  • Manufacturing
  • QA/QC staff
  • Compliance officers
  • Supply Quality/Supply Chain managers
  • Regulatory/legislative affairs professionals

Register Now

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.

Webinar Details
Date: Tuesday, April 20, 2010
Location: Your office or conference room (No need to travel!)
Time: 1:30 p.m. – 3:00 p.m. EDT
12:30 p.m. – 2:00 p.m. CDT
11:30 a.m. – 1:00 p.m. MDT
10:30 a.m. – 12:00 p.m. PDT
6:30 p.m. – 8:00 p.m. GMT
Price: Webinar PLUS Audio CD and Transcript: $527— Best Value!
You’ll have access to one log-in and dial-in for the live 90-minute webinar for unlimited participants. You also receive all presentation materials and the opportunity to ask question by phone and email, plus an audio CD and transcript for the entire session.

Webinar Only: $327
You get one log-in and dial-in for the live 90-minute webinar for unlimited participants, presentation materials and the opportunity to ask question by phone and email.

Invite your entire team for maximum benefit!
Register TODAY for one dial-in and log-in —
and bring as many participants as you wish.

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Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally to learn about our special multisite discount.

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Please mention priority code 10329 when registering.

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    Use your American Express, Visa or MasterCard.
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Can’t Attend?
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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