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

Course Description:

This medical foods regulatory compliance training will explain 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 provided.

Course Objective:

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.

Course Outline:

  • 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.

Target Audience:

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
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