21 CFR 111 Dietary Supplement GMP Overview at Expo West, Engredea 2018

Anaheim , California
Wednesday, March 07, 2018
21 CFR 111 Dietary Supplement GMP Overview at Expo West, Engredea 2018
Wednesday, March 07, 2018 8:00 AM -
Thursday, March 08, 2018 5:00 PM (Pacific Time)

Expo West Anaheim Convention Center
US, HS, DS, GMP, CR
800 West Katella Avenue
Anaheim , California 92802
United States

Map and Directions
Please use the NSF registration button in the upper right hand corner of the page to register for the GMP course being held at Expo West, Engredea - Anaheim CA

A Tradeshow pass is needed to attend the course.

Early Registration, Now - February 3: $1200.00

Advance Registration February 4 -  March 3 : $1400.00

March 4 - Onsite  March 4 - Onsite : $1600.00

About This Course 
All companies that manufacture, package, or hold dietary supplement are dietary supplement manufacturers and the FDA expects you to follow 21 CFR 111, the Dietary Supplement CGMPs. This course provides a comprehensive overview of the CGMPs and the responsibilities expected of all employees working in this industry. Participants will learn how to apply CGMP principles to specific situations. The course is designed to be interactive, with hands-on exercises including case-studies based on real situations taken from recent FDA Warning Letters. Bring your questions and be prepared to participate with the instructor and your peers.

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

Who Should Attend?

Anyone from:
• Management
• Laboratory Operations
• Manufacturing
• Auditing
• Quality Control/Assurance
• Suppliers and Distributors
• Packaging • Regulatory Affairs
• Marketing

Class Length:                    Two days
Course Prerequisites:       None

Course Outline
At the conclusion of the course participants will have an understanding of the following: 
         • Basic requirements of the CGMPs.
         • Details of CGMPs as they relate to:
o Personnel
o Buildings and Facilities
o Equipment 
o Facility Records 
o Production and Process Control 
o Holding and Distribution 
o Batch Records
o Packaging and Labeling
o Quality Control and Quality Assurance
o Laboratory Operations
o Product Complaints
        • The purpose of “Guidance Documents”
        • The role of the FDA and their authority
        • The roles and responsibilities of the Quality Unit

Benefits of taking this course:

• Your specific questions can be discussed
• Learn CGMPs in a way that enables you to teach others
• Network with other professionals in the industry
• Learn best practices from the instructor and other attendees
• Meet your annual GMP training requirements
   
 

Contact Information

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