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:
Who should attend:
This webinar will provide valuable information to:
- Shawn K. Stevens
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...
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