The New Dietary Supplement Good Manufacturing Practices

Why Should You Attend:

The FDA has issued the final rule (June 22, 2007) establishing regulations to require current good manufacturing practices (CGMPs) for dietary supplements. These new regulations will require that dietary supplement manufacturers put into place proper controls to insure that dietary supplements are processed in a consistent manner and meet quality standards. To limit the disruption to dietary supplements businesses, the final rule has been staggered over a three-year period based on the size of the organization. The final CGMPs is effective June 2008 for large companies, June 2009 for companies with less than 500 employees, and June 2010 for companies with less than 20 employees. This presentation will highlight from a quality perspective the introductory requirements of these new CGMP regulations and will examine methods and strategies for meeting these new requirements, especially for organizations with limited resources.

Areas Covered in the seminar:

• General Provisions.
• Personnel.
• Physical Plant.
• Equipment and Utensils.
• Production and Process Control Systems.
  • Establish Production and Process Control System
  • Requirements for Quality Control
  • Requirements for Components, Packaging and Labels
  • Requirements for the Master Manufacturing Record
  • Requirements for the Batch Production Records
  • Requirements for Laboratory Operations
  • Requirements for Manufacturing Operations
  • Requirements for Packaging and Labeling Operations
• Holding and Distribution.
• Returned Dietary Supplements.
• Product Complaints.
• Records and Record Keeping.
• Strategies for implementation.

Who Will Benefit:

This webinar will provide basic information about the CGMPs for supplement manufacturers or for new companies that are anticipating manufacturing new dietary supplements. The individuals who will benefit include:

• End users responsible for the various aspects of day-to-day production of dietary supplements
• Physical plant and maintenance personnel
• Operators of automated, mechanical or electronic manufacturing equipment
• Quality control and quality system personnel
• Laboratory and lab testing personnel
• Production and process control personnel
• Packaging and labeling personnel
• Manufacturing engineers and personnel
• Regulatory personnel
• Plant managers
• Quality system auditors
• Consultants

Instructor Profile:

John Suzuki, is the founder and owner of JKS & Associates, a consulting firm that specializes in the implementation of quality systems for the regulated industries and in equipment and automated computer systems validation. He has extensive experience in the laboratory and diagnostics industries and has consulted with both large and small companies in the pharmaceutical, biotech, and medical device industries. He has participated in several industry and FDA joint working groups and has experience with implementing FDA-type quality systems in several types of companies and industries.

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