Understanding Combination Products: Navigating the Rules and Regulations
Duration: 60 Minutes
This training will help you understand what a combination product is, highlight some of the changes in how the FDA views combination products, the approval steps for combination products and proposed regulations for these types of products.
Objectives of the Presentation
Why Should you Attend
- 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
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.
Who will Benefit
- Combination product examples
- Complexity surrounding combination products
- Combination product regulations
- Combination product approval process
- Combination product cGMPs
- Warning Letter case study review
- 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