Type 2 DMFs for Active Pharmaceutical Ingredients (APIs)

Why Should You Attend:

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.

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

Who Will Benefit:

This presentation is targeted toward the following organizational positions and disciplines and is presented in practical language understandable by all technically educated or trained individuals, regardless of specialty. This information would be useful at levels from senior management to operative and would be valuable for experience levels ranging from seasoned veterans to those newly assigned to roles related to manufacturing:

• Quality Assurance
• Quality Control
• Process and Design Engineering
• Process Automation
• Manufacturing Operations
• Validation
• Utility Operations
• Regulatory Affairs

Instructor Profile:

Peggy J. Berry, MBA, RAC, is the president and 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). She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held regulatory affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992).

In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book “Choosing the Right Regulatory Career” (RAPS, MD) and author of the 2011 book “Communication & Negotiation” (RAPS, MD).

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