SupplySide China 2018

June 28-30, 2018 • Area B, China Import and Export Fair Complex, Guangzhou, China

Training Program A – GMP Training Program (Two-Part Training)

Date: June 27-29, 2018 (3 Days)
Venue: Meeting Room 4, Level C, Conference Building
Time: 09:00 – 17:00
Number of Trainees: 25

PART ONE: 21 CFR 111 cGMP Training

Course Description:

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 CGMPs. 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.

Course Prerequisites

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.

  • Interpretation of each subpart, providing an understanding of how to apply the principles to an employee or company’s specific situation.
  • Simulate a real scene to analyze the company’s compliance in high-risk fields.
  • Thorough review of some of the recent FDA Warning letters submitted to dietary supplement. companies and evaluation of their non-conformances with the regulations.
  • Discuss the challenges of quality control and cGMP implementation with other attendees.
  • Introduce comprehensive GMP to new and existing employees, including QA/QC, Manufacturing/production department, R&D, etc.
  • Management; Manufacturing;
  • Quality Control/Assurance;
  • Laboratory Operations;
  • Auditing;
  • Suppliers and Distributors;
  • Engineering security;
  • Regulatory Affairs.
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PART TWO: Vendor Qualification & Audit Training

Course Description:

Unless you intend to test every shipment of every component for every specification, you must qualify your vendors. The FDA does not provide much guidance on how to qualify vendors. This class is designed to give people who want to improve quality in their facility and who already have a basic understanding of the Dietary Supplement GMPs, the knowledge and skills necessary to qualify suppliers.

Course Prerequisites

Course Prerequisites: Participants should have taken NSF’s 21 CFR 111 Dietary Supplement CGMP Overview or equivalent. A Certificate of Attendance will be provided upon completion of the course.

  • Find out how to effective manage your suppliers and what FDA is focusing on.
  • Learn and review the audit professional knowledge and skills.
  • Your specific questions can be discussed.
  • Network with other professionals in the industry.
  • Learn best practices from the instructor and other participants.
  • Management;
  • Manufacturing;
  • Quality Control/Assurance;
  • Laboratory Operations;
  • Auditing;
  • Suppliers and Distributors;
  • Regulatory Affairs;
  • Purchasing;
  • Product Development.

Training Program B – FSMA:Prevent Controls for Human Food Training (PCQI)

Date: June 27-29, 2018 (2.5 Days) Venue: Meeting Room 5, Level C, Conference Building
Time: 09:00 – 17:00 Number of Trainees: 25

Course Description:

In September 2015, the US Food and Drug Administration (FDA) published the final version supporting regulation of the Food Safety Modernization Act (FSMA) Regulation: ” Current Good Manufacturing Practice, Hazard Analysis, and Risk Based Preventive Controls for Human Food ” (21 CRF PART 117, referred to as the Preventive Controls for Human Food regulation”.

The regulations require that each food factory need a “prevent and control qualified person” who can establish a food safety program.

  • Professional discussion of corporate good manufacturing practices and prerequisites.
  • Conduct hazard analysis and determine preventive control measures.
  • Defined processes, food allergens, hygiene and supply chain prevention control.
  • Get more professional hazard analysis, confirmation, recall and record keeping requirements.
  • Manager of food safety department in the company which export food or ingredients of dietary supplement to USA;
  • QA & QC;
  • Lab Manager;
  • Auditor;
  • Food Safety Program Founder;
  • Supplier & Distributor;
  • Regulatory Officer;
  • Personnel who supervises the food exporting enterprise and personnel from third party for compliance certification.
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Participants who attend and complete this course will receive a training certificate from FSPCA Preventive Controls for Human Food (FSPCA-PCQI) approved by the FDA.

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