Medical Foods Complex FDA Requirements for Claims & Quality

Medical Foods: Practical Tips to Meet FDA Requirements for Claims and Quality

Event Information
Product Format
Prerecorded Event
Presenter(s)
Length
60 minutes
Product Description

Demystifying FDA’s Complex Requirements for Medical Foods

Medical foods play a vital role in the management of patients with special dietary restrictions and needs. The FDA regulates medical food through special handling, labeling, distribution and manufacturing requirements. Manufacturers are usually apprehensive about meeting all of FDA’s complex requirements for such products due to a gap in knowledge.

Join expert speaker Dr. Mukesh Kumar in this webinar to discuss the regulatory processes involved in designating and marketing a product as medical food. He will also shed light on common issues with FDA compliance using case studies and share potential solutions to the problems.

Why should you attend?

Medical foods designation comes with its own set of regulatory responsibilities. FDA expects manufacturers to self-assure compliance status and reserves the option to audit all aspects of the manufacturing, labeling and distribution as it deems necessary. This session fills the gap in knowledge in terms of the FDA expectations from medical foods and way to address common deficiencies. The case studies discussed will further highlight potential audit issues, training requirements, good manufacturing practices for medical foods, and marketing concerns. 

Topics Covered in the Session:

  • Current FDA-accepted definition of medical foods and functions foods
  • Overview of Medical foods and dietary supplements
  • Learn about the good manufacturing practices for medical foods
  • Find out the best practices for marketing and distribution
  • Discussion on the case studies from unsuccessful and successful marketing of medical foods
  • Tips and tools for training of sales and marketing teams in medical foods
  • Learn about the regulatory strategies for designating dietary supplements and medical foods

Who should attend: 

This webinar will provide valuable information to:

  • Manufacturers of medical foods
  • Physicians and hospital personnel
  • Dietary supplement manufacturers
  • Marketing and Advertising Professionals
  • Regulatory affairs professionals, research analysts

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About Our Speaker

Dr. Mukesh Kumar - Pharma Regulation Expert

Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials, and multi-national project management for medicinal and diagnostic products. He has been involved in about 100...   More Info
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