Combination Products – Applying the Appropriate Regulations

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Combination products are the newest and most complicated of products regulated by the FDA and other global regulatory agencies. In general, a combination product is composed of two or more regulated products such as a medical device and a drug/biologic such that both are combined together and are required to achieve the intended result. The FDA’s Final Rule concerning combination products has been recently published and defines the regulations that apply to the various combinations of combination products. Navigating this rule and the regulations of our global neighbors is a challenge for manufacturers.

This webinar is essential for those who are currently manufacturing combination products or anticipating submitting potential products for approval. This webinar will provide the knowledge necessary to determine the regulations that apply to common combination product types. GMPs for combination products will also be discussed in addition to a discussion of the particular challenges facing manufacturers today.

Areas to be Covered:

Combination Products Overview
Combination Products and US Regulations
Combination Product Approval Process
GMPs for Combination Products

Who will Benefit:

Drug Development Professionals
Medical Device and Diagnostics Professionals
Biologics Professionals
Regulatory Professionals
Quality Professionals
Clinical Professionals
Product stewards
Business development executives involved in combination product strategic partnerships
Research & Development
Product Testing Professionals
Combination product supply chain professionals
Anyone involved in the design, development, or distribution of combination products

Charles Paul

Charles Paul is an instructional designer and management consultant with over 30 years’ experience providing training and consulting services to regulated industries. He has installed quality systems and designed and developed GMP and operational documentation and training programs for foods and beverage, pharmaceuticals, biotech, cosmetics, and consumer product – OTC industries.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance