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

Why Should You Attend:

Medical foods designation comes with its own set of regulatory responsibilities. The designation of medical food by FDA implies special handling, labeling, distribution and manufacturing requirements. Manufacturers are usually worried about meeting all of FDA’s complex requirements for such products. 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 webinar 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 issues.

Areas Covered in the Webinar:

• Current FDA accepted definition of medical foods and functions foods.
• Medical foods and dietary supplements.
• Good manufacturing practices for medical foods.
• Best practices for marketing and distribution.
• Review of case-studies from unsuccessful and successful marketing of medical foods.
• Practical tips for training of sales and marketing teams in medical foods.
• Regulatory strategies for designating dietary supplements and medical foods.

Who will Benefit:

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 in the medical foods industry
• Executive management of medical foods manufacturing companies

Instructor Profile:

Dr. Mukesh Kumar, is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He and leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD. 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 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.

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