TRANSCRIPT

Description

CGMP refers to the Current Good Manufacturing Practice regulations enforced by the U.S, Food and Drug Administration (FDA). CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.

This webinar will convey an understanding  of key U.S. Dietary Supplement CGMP regulatory requirements and cover the importance of complying with FDA CGMP requirements for Dietary Supplements. The CGMPs apply to all domestic and foreign companies that manufacture, package, label or hold dietary supplements, including those involved with the activities of testing, quality control, packaging and labeling, and distributing them in the U.S. The GMPs for industry-wide use require that dietary supplements are manufactured consistently as to identity, purity, strength, and composition and it is critical that companies marketing U.S. Dietary Supplements comply with these regulations.

Areas Covered In The Session:

This presentation will cover the following GMP requirements:

  • The design and construction of physical plants that facilitate maintenance and cleaning,
  • Proper manufacturing operations,
  • Quality control procedures,
  • Testing final product or incoming and in process materials,
  • Handling consumer complaints, and
  • Maintaining records.

Learning Objectives:

  • To understand the key aspects of FDA Dietary Supplement CGMP requirements in the USA
  • To learn the basics of FDA CGMP regulatory requirements for manufacturing
  • To learn and understand CGMP quality control procedure and regulatory
  • To learn FDA CGMP testing and packaging rules and regulations
  • To learn rules and regulation for holding dietary supplements in the USA.

Target Audiences:

  • Regulatory Affairs managers and associates
  • Quality Assurance managers
  • Operations managers
  • Plant managers and associates
  • Manufacturing manager and staff
  • Packaging manager

About Our Speaker:

Norma Skolnik has over 35 years of regulatory experience working with the pharmaceutical and dietary supplement industries. She served as Director of Regulatory Affairs for the Americas for Cadbury Adams. Prior to that she was Director of Regulatory Affairs for the Adams Division of Pfizer and Associate Director of Regulatory Affairs for the Warner-Lambert company. She also served as Director of Regulatory Affairs for Lederle Consumer Healthcare and as Associate Director of Marketed Product Support for Lederle Laboratories and Associate Director of Regulatory Affairs for Wyeth. She currently works as a consultant to those in the OTC Drug and Dietary Supplement industries.