Introduction to Combination Products: Navigating The Rules and Regulations

Dr. Ginette Collazo

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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.

Course Objective:

  • Define the term "Combination Products"
  • Identify and explain the US Regulations that pertain to combination products
  • Explain the combination product approval process
  • Identify and explain the GMPs for combination products

Course Outline:

  • Combination product examples
  • Complexity surrounding combination products
  • Combination product regulations
  • Combination product approval process
  • Combination product cGMPs
  • Warning Letter case study review

Target Audience:

  • Regulatory, quality, and clinical professionals involved with combination product development and oversight
  • Product stewards
  • Business development executives involved in combination product strategic partnerships
  • R&D and product testing professionals
  • Combination product supply chain professionals
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

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Speaker: Dr. Ginette Collazo,

GINETTE COLLAZO, PH.D is a human error and human behavior expert. She has spent more than 15 years in technical training, organizational development and human reliability areas. She has worked with Bristol-Myers Squibb, Johnson & Johnson, Schering-Plough, Wyeth, and has been a consultant with major firms like Abbott, Johnson & Johnson, Perrigo, among many others. Also has implemented human error reduction programs and technology in many more small and mid-sized drug and device companies. An active researcher in specialized studies related to human reliability, she is the author of numerous publications on these topics.

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