Combination Products – The FDA New Codification of the cGMP Requirements Applicable to Combination Products

Live, Interactive Training Webinar

Available Live On-Demand
Instructor: Barry A.Friedman Ph.D. Biography>>>

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Historically, the absence of clear cGMP requirements for Combination Products has resulted in inconsistent application as to the applicable Agency Center to submit product for review. Products for both CDER and CBER as the primary Agency contact point may have historically been submitted to the incorrect organization for review because of a lack of knowledge as to the Primary Mode of Action (PMOA) of the product. While some of these product applications might have been relatively easy to discern, e.g., a pre-filled syringe (usually CDER), other products may have had great difficulty finding the “correct home”. In October 2004, the FDA issued a Draft Guidance for Industry entitled “Current Good Manufacturing Practice for Combination Products”. NINE years later, the FDA now CODIFIED (JANUARY 2013) the cGMP requirements applicable to combination products. This NEW rule is intended to promote the public health by clarifying which cGMP requirements apply when drugs, devices, biological products and human cell and tissue products (HCT/Ps) are combined to create a combination product. This permits both a client company and the FDA to move the product through the regulatory system most efficiently. The new rules also discuss a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with cGMP requirements for single-entity and co-packaged combination products.

The objective of this live training webinar is to explore this new rule and guidances for the industry as they apply to your organization and examine options for obtaining compliance within a cGMP framework.

Learning Benefits:
-The New 2013 cGMP Requirements for Combination Products.
-Clarification of the cGMP Requirements that apply to Combination Products.
-Ensuring the Consistent and Appropriate Application of these Requirements.
-Examination of the various Guidances for Industry.
-Determining the Primary Mode of Action (PMOA).
-Learning how to Streamline the Practical Implementation of cGMP Requirements.
-Ensuring that cGMPs for Co-Packaged and Single-Entity Combination Products are Consistent and Appropriate without Duplication.
-Determining what new cGMP Requirements may be required.

Webinar outline and time breakdown:

Time*
09:15 AM Log In Period
09:30 AM Introduction
09:40 AM Definitions,
Combination Products – Codification of Rules,
Combination Products – What are they,
Examples of Combination Products,
10:30 AM Break
10:40 AM Products – Primary Mode of Action (PMOA),
Designations, Assignments, and Miscellaneous,
The Guidances for Industry,
Europe – MHRA,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training webinar includes the following for each registered attendee:

  • A copy of the presentation slides
  • A certificate of training for attendee records

Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:

  • Quality Assurance personnel
  • Quality Control personnel
  • Research & Development
  • Regulatory Affairs Professionals
  • Validation
  • Legal
  • Those that use contract manufacturing and contract testing facilities
  • Auditors


Instructor: Barry A. Friedman Ph.D.

Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing arena. Dr. Friedman is a frequent seminar speaker in the GMP areas of internal auditing, aseptic processing of sterile drug products, USP microbiology, validations and the requirements for the manufacture of Phase 1, 2 and 3 clinical trial materials. He has recently given presentations for the FDA, PDA, PTi. He is a member of AAMI, ASM, PDA and RAPS. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President of the Capital Area Chapter, PDA... Full Bio>>>

 

 

Course Number: 232

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