2014 - Medical Foods:Practical Tips to Meet FDA Requirements for Claims and Quality

Instructor: Mukesh Kumar
Description:
Medical foods play an important role in the management of patients with special dietary restrictions and needs. 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. This seminar will discuss the regulatory processes to designate and market a product as medical food. Common issues with FDA compliance will be discussed using case studies and potential solutions will be discussed.
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 seminar 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.
Objectives of the Presentation:
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 can 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
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