Training Course: 21 CFR 111/NSF Std 173-8 Dietary Supplement cGMP

Date:  Thursday, September 20 – Friday, September 21, 2018 

Location:  Shanghai

NSF Dietary Supplements

NSF Dietary Supplements provides services to the dietary supplement industry, focusing on improving quality systems and increasing the knowledge of your employees, providing custom analytical testing services and assisting companies in meeting regulatory requirements, both in the U.S. and internationally.

At NSF Dietary Supplements, our consultants and scientists possess extensive knowledge and expertise in both the dietary supplement and pharmaceutical industries. Our team is available to assist you in solving your most challenging dietary supplement quality, method development and regulatory issues.

About This Course

FDA expects all companies that manufacture, package, or hold dietary supplement products,also include the relative resources /ingredient and excipient manufacturers to follow 21 CFR 111, the Dietary Supplement cCGMPs. As a part of maintaining compliance to 21 CFR 111, dietary supplement personnel must have GMP training on a regular basis. This course provides a basic understanding of cGMPs and the responsibilities expected for various individuals and groups within the company. Participants will learn how to apply cGMP principles to specific situations. The course is interactive, with hands-on exercises including case-studies from recent Warning Letters. Bring your questions and prepare to interact with the instructor and your peers in the industry.

Who Should Attend

  • Management
  • Manufacturing
  • Quality Control/Assurance
  • Laboratory Operations
  • Auditing
  • Suppliers and Distributors
  • Engineering security
  • Regulatory Affairs

As a part of maintaining compliance to 21 CFR 111, dietary supplement personnel must have GMP training on a regular basis. A Certificate of Attendance will be provided upon completion of the course.

What You Will Learn

  • Basic requirements of the CGMPs.
  • Details of CGMPs as they relate to:

                   Personnel
                   Buildings and Facilities
                   Equipment 
                   Facility Records 
                   Production and Process Control 
                   Holding and Distribution 
                   Batch Records
                   Packaging and Labeling
                   Quality Control and Quality Assurance
                   Laboratory Operations
                   Product Complaints

  • The purpose of “Guidance Documents”
  • The role of the FDA and their authority
  • The roles and responsibilities of the Quality Unit

Details Outline

DAY 1 DAY 2
  • Why do we need to follow GMPs?
  • FSMA briefing; it’s impact on dietary supplements 
  • Subpart A – General Provisions
  • Subpart P – Records and Record Keeping
  • Subpart H – Master Manufacturing Records
  • Subpart I – Batch Production Records
  • Subpart B – Personnel
  • Subpart C – Physical Plants and GroundsSubpart D – Equipment and Utensils
  • Subpart E – Production and Process Control 
  • Subpart K – Manufacturing Process Control
  • Subpart F – Quality Control
  • Subpart J – Laboratory Operations
  • Subpart G – Components, Packaging, and Label Control
  • Subpart L – Packaging and Labeling Control System
  • Subpart M – Holding and Distribution
  • Subpart O – Complaints

The course is interactive, with hands-on exercises including case-studies from recent Warning Letters. Bring your questions and prepare to interact with the instructor and your peers in the industry.

Training Fee:

  1. RMB 3,500/person
  2. Current NSF Client RMB 3,200/person

Training Registration:

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