Medical Foods: Practical Tips to Meet FDA Requirements for Claims and Quality
May 22, 2013
Location
san Francisco
38868 Salmon Ter, Fremont California 94536
san Francisco, California 94536
USA
Description
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
Additional Information
Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes.
Organized by
online compliance panel
38868 Salmon Ter, Fremont California 94536
san Francisco, California 94536
United States of America
More Information
Contact: martin luthur
Email: onlinecompliancepanel1@gmail.com
Phone: +1-510-857-5896
Event's Website
