ComplianceOnline

Mastering Change Control Before It Masters You - An Essential Course for Drug Master File 'Owners' AND Finished and Supplied Product Manufacturers

Instructor: Amy E Fortenberry
Product ID: 701471
  • Duration: 90 Min

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This change control webinar training will provide essential compliance information on current regulatory standards under 21 C.F.R. and FDA’s Guidance Documents and Draft Guidance Documents for managing DMFs and associated Change Control effects and implementation strategies.

Why Should You Attend:
This Webinar, will give a brief overview of Drug Master Files (DMFs) and their commonalities with Device Master Files (MAFs), Veterinary Master Files (VMFs), and Master Files for Biologics found as either DMFs within CBER or CDER or in Biologics Licensing Applications (hereinafter collectively referred to as “DMFs”). This will enable participants to place the matter of DMFs in context as we explore the effect of Change Control on manufacturers and their up-stream customers.

We will then plumb the depths of the manufacturing processes and procedures as well administrative matters that are affected by or effect Change Control crises. In discussing the complexities of managing Change Control no matter where your company is in the Supply Chain, we will also delve into legal agreements such as sales and supply agreements, safety agreements, outsourcing agreements, and agreements within mergers and acquisitions for growth, spin-offs, or downsizing — all of which can be the cause of or affected by Change Control mishaps.

Change Control crises can emerge full blown from such a small singular event as the example given by a kingdom’s loss triggered by a soldier’s horse losing a nail in one of its horseshoes — “for want of a nail the shoe was lost . . ..” A Change Control crisis can accrete like silt in a dam through a manufacturer’s years of lack of proper recordkeeping of procedures. And, as a final example, we will explore how a Change Control crisis can be a corporate train wreck — involving many trains, many companies — if the Change Control origins are traceable to lack of proper recognition and recordkeeping for the DMF associated with a product or facility subject to the terms of an agreement in a merger, acquisition, spin-off, downsizing, or outsourcing, even if the corporate agreement that was the catalyst occurred decades ago.

This Webinar will provide essential executive and supervisory level compliance information on current regulatory standards under 21 C.F.R. and FDA’s Guidance Documents and Draft Guidance Documents for managing DMFs and associated Change Control effects and implementation strategies.

Areas Covered in the seminar:

  • Brief Overview of the core content of Drug Master Files (DMFs) and the terms of their submission to FDA.
  • Brief Overview of the use of DMFs in marketing and sales and how authorizations are provided up the Supply Chain for reliance upon a DMF (via Letters of Authorization (LOAs)).
  • Dissection of the provisions of 21 C.F.R. that set forth the regulation and definition of Change Control for DMFs.
  • How to recognize Change subject to Change Control.
  • How to institute measures to Manage Change Control within the company for each DMF "owned" (technically the term is "held") by a manufacturer.
  • How to communicate to customers and up-stream manufacturers about change in the product, its manufacturing process or facility, or its product-associated DMF.
  • Pilot Programs including the Sentinel Pilot Program.

Who will benefit:

  • Senior Executives responsible for ultimate product safety and compliance
  • Senior Executives responsible for production or marketing goals
  • Senior Executives responsible for marketing and production goals and associated site location(s): in growth, downsizing, mergers & acquisitions, or moves
  • Regulatory Affairs Directors and Managers
  • Attorneys (in-house or outside counsel) responsible for supply agreements, quality agreements, change control agreements, or mergers and acquisitions (or downsizing)
  • Managers responsible for supplier selection
  • Managers responsible for customer service needs
  • Managers responsible for customer marketing
  • Managers for Finished Product Specifications and compliance therewith
  • Senior Executives Responsible for Goals and associated site location(s): in growth, downsizing, mergers & acquisitions, or moves

Instructor Profile:
Amy E. Fortenberry, is the Director of Regulatory Affairs for DMF Management Systems, LLC, through which she provides business counseling, litigation prevention, and regulatory compliance advice in the life sciences and pharmaceutical arena. For the past decade, Ms. Fortenberry practiced as a food and drug law attorney in some of the largest law firms in the United States.

She is a founder and the Legal Representative on the Executive Steering Committee of the Drug Master File (DMF) National Workshop for Drugs and Biologics, a national committee comprised of representatives from several Centers at FDA as well as national pharmaceutical, biologics, and packaging companies. Ms. Fortenberry also has worked with clients on compliance for tissue banking and tissue research. Prior to law school, she worked for five years at the U.S. Centers for Disease Control and Prevention (CDC), three years of which she spent in HIV/AIDS research and information.

Ms. Fortenberry received her B.A., summa cum laude, from Georgia State University, and her J.D., with Environmental Certification, from Boston College Law School, where she served as the Managing Editor of the Boston College Environmental Affairs Law Review.

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