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Understanding Combination Products: Navigating the Rules and Regulations

3938
Duration : 60 Minutes

Charles H. Paul,

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults Read more


This webinar will begin by first defining combination products in terms of the complexities that combination products present to the organization from a device and pharma/biologic standpoint.  The webinar will then move on to the regulations governing how combination products are regulated.  Various scenarios will be presented that will discuss how and which regulations apply depending upon the facility and the device.  A job aid will be provided as a webinar enhancement that will make the complex process of regulation application simple to understand.

The approval process for combination products will also be detailed as it differs from a purely medical device or purely pharma or biologic product.

The webinar will complete with a review of 483’s that illustrate the concepts presented making real the approaches for regulatory and GMP application.

Background:

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 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.

Why Should You Attend:

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

What You Get:

•  Training Materials
•  Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• 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

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

Get In Touch

Subject : Understanding Combination Products: Navigating the Rules and Regulations


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