Understanding Combination Products: Navigating the Rules and Regulations

Duration: 60 Minutes
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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.
FDA’s Final Rule concerning combination products
Instructor: Charles H Paul
Product ID: 508549
Objectives of the Presentation
  • 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
Why Should you Attend
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 Covered
  • Combination product examples
  • Complexity surrounding combination products
  • Combination product regulations
  • Combination product approval process
  • Combination product cGMPs
  • Warning Letter case study review
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
$375
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Live Session - How it works
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  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Charles H. Paul is the President of C. H. Paul Consulting, Inc. - a regulatory, Lean Manufacturing, 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 with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars in a variety of related subjects from documentation development to establishing compliant preventive maintenance systems. The firm works globally completing projects throughout the EU, UK, South America, and Asia.
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