Key Take Away:

This webinar will address approaches to developing and understanding the manufacturing process for a drug substance. The information obtained will enable completion of the drug substance information in the Drug Master File – in support of Module 3 of a CTD application.

Overview:

The webinar will address aspects of development and manufacture of the drug substance for pharmaceutical manufacturing and drug manufacturers, including steps to reduce impurities. Both traditional and enhanced compliance regulation approaches are discussed.

Type 2 DMFs for Active Pharmaceutical Ingredients (APIs) are needed in order to protect confidential information and allow the ability for API manufacturers to sell to multiple customers, while providing and updating their information in only one submission and one format.

Why Should You Attend:

Information provided in the DMF must cover all required sections of the International Conference on Harmonization (ICH) CTD guidance document covering the Module 3 pharmaceutical drug substance section.

This section requires details about the development of the API, raw materials, equipment, formulation, critical attributes, manufacturing process and controls, analytical methods, specifications, and stability.

In this webinar, you will learn the required contents of Module 3 as well as the appropriate formatting. Lifecycle management and updating requirements will be discussed, including appropriate change control and sponsor notifications.

You will also gain an understanding of contact points with the FDA throughout the lifecycle of the DMF, including information requests and inspections.

Areas Covered In This Webinar:

• Manufacturing process development

• Process controls

• Selection of starting materials

• Control strategy

• Process validation evaluation

• Submission of information into the DMF, content & format

• Providing letters of reference to support a sponsor CTD

• Life cycle management of the DMF

• Interactions with the FDA throughout the DMF lifecycle

Learning Objectives:

• Learn the required contents of Module 3 as well as the appropriate formatting

• Lifecycle management and updating requirements, including appropriate change control and sponsor notifications

• Gain an understanding of contact points with the FDA throughout the lifecycle of the DMF, including information requests and inspections

Who Will Benefit:

• Quality Assurance Personnel

• Quality Control (Chem and Micro) Personnel

• Process and Design Engineering Professionals

• Process Automation Personnel

• Manufacturing Operations Staff

• Validation/ Utility Operations/ Regulatory Affairs Personnel

Speakers Profile:

Peggy J. Berry
Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014).

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