21 CFR 111 Dietary Supplement GMP Overview

Dallas/Fort Worth TX, Texas
Tuesday, February 06, 2018
                                  
21 CFR 111 Dietary Supplement GMP Overview
Tuesday, February 06, 2018 8:30 AM -
Wednesday, February 07, 2018 5:00 PM (Central Time)

Dallas/Fort Worth TX
US, HS, DS, GMP, CR
Fort Worth, TX
Dallas/Fort Worth TX, Texas TBD
United States

Map and Directions

DS - 21 CFR 111 Dietary Supplement GMP
Cost: Current NSF Dietary Supplement Client $1100/ General $1500 


About this Course:
FDA expects all companies that manufacture, package, or hold dietary supplement products to follow 21 CFR 111, the Dietary Supplement CGMPs. 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?
Anyone from:  
• Management
• Manufacturing
• Quality Control/Assurance
• Packaging 
• Marketing
• Laboratory Operations
• Auditing
• Suppliers and Distributors
• Regulatory Affairs

Class Length:                 Two days
Course Prerequisites:    None
What You’ll Learn:
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:
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
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.

Benefits of taking this seminar:
Get answers to your specific questions
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

Details Outline:
• Why do we need to follow GMPs?  
FDA’s legal authority
The meanings of:
483
Regulatory meetings
Warning Letter
Fines
Consent Decree
Seizure
Injunction
Indictment
FDA’s definition of adulteration and quality
    
How to respond to 483s and WLs
• FSMA briefing; it’s impact on dietary supplements
• 21 CFR 111: Subpart A – General Provisions
Who has to comply with 21 CFR 111?
FDA’s definitions of important terms

• 21 CFR 111: Subpart P – Records and Record Keeping
What are GDPs, and to what documents are they applicable?
What are FDA’s expectations for SOPs?
What are the requirements for electronic records?
What records must be made available to FDA?
How do you correct errors? 
Recalls
Retention requirements

• 21 CFR 111: Subpart H – Master Manufacturing Records
What is an MMR and how is it different from a BPR?
When must you create an MMR?
What must be included in an MMR?
Specifications
Controls
Procedures
Components
Packaging
Theoretical yield
Labeling

• 21 CFR 111: Subpart I – Batch Production Records
When must you create a BPR?
What must be included in a BPR?
Components
Monitoring results
Yields
Labels & Reconciliation
Review & Disposition
Reprocessing
Initial/date requirements

• 21 CFR 111: Subpart B – Personnel
Hygienic Practices – Disease Control
Protective garb, standard practices
Jewelry policy
Employee and manager qualification
Training documentation
Where does QA fit into the company organization?

• 21 CFR 111: Subpart C – Physical Plants and Grounds
Why does the building perimeter need to be clear?
Can toxic materials be stored in the plant?
What are the requirements for pest control?
Water testing requirements and best practices
Piping and drain design
The importance of minimizing dead-legs
Floors, walls, and ceiling construction
Three Zone design for people, air, and material flows

• 21 CFR 111: Subpart D – Equipment and Utensils
How to set up systems for:
Calibrating, inspecting & checking equipment, instruments,
and controls
Maintaining equipment, utensils and surfaces

         Cleaning and sanitizing surfaces, equipment and utensils
How does a User Requirements Specification show that equipment is
designed correctly
How can you show FDA that your equipment is 
Corrosion-resistant  
        Made of nontoxic materials
Equipment cleaning and usage logs

• 21 CFR 111: Subpart E – Production and Process Control 
How to document that your process control system has been designed to ensure the quality of the product as specified in the Master Mfg Record.
What specifications must you have?
Every component
In-process specifications 
Limits on contamination
Labels 
Packaging material
Finished product
How do you prove that you have met your specifications?
Do you have to test every batch?
When might skip lot testing be applicable?
How does FDA define COA?
Supplier qualification; do you need to audit your suppliers?
How do you handle deviations?

• 21 CFR 111: Subpart K – Manufacturing Process Control
Contamination prevention
Allergens
Monitoring microbial levels
Mechanical steps
Time & temperature controls
Metal contamination
Segregate and identify
Identify lines & equipment

• 21 CFR 111: Subpart F – Quality Control
Required SOPs
Responsibilities 
Procedures
Specifications
Processes
Tests
Examinations
Controls
Deviations
Investigation Review
Dispositions
Material Reviews
When required
How to conduct effectively
How to know if you’ve found the root cause

• 21 CFR 111: Subpart J – Laboratory Operations
Procedures that must be in place
Criteria for establishing specifications
Use of sampling plans
Criteria for selecting appropriate test methods
The meaning of “scientifically valid methods”
The difference between precision and accuracy
Stability testing

• 21 CFR 111: Subpart G – Components, Packaging, and Label Control
Receiving procedures
Warehousing requirements

• 21 CFR 111: Subpart L – Packaging and Labeling Control System
Required procedures
Label reconciliation
Why is FDA so paranoid about label mix-ups?
Repackaging and relabeling

• 21 CFR 111: Subpart M – Holding and Distribution
What constitutes appropriate conditions of:
   T emperature
Humidity
Light
Requirements for reserve samples
New requirements from FSMA

• 21 CFR 111: Subpart O – Complaints
The definition of a product complaint
Requirement for an investigation
The difference between a product complaint and a serious adverse event
• FDA Inspections
Training your employees how to respond to an inspectors’ questions
Documents that are exempt from FDA inspection
Role of the escort
• Cultural Transformation; a short discussion of what you do once you have all your SOPs written.  How do you achieve compliance in the real world?

Instructor:
TBD

Discounts Offered: 

10% if 3 or more persons from the same organization registers for a class

10% if a registrant completes all courses being offered at a location

15% if 3 or more persons from the same organization takes all classes being offered at a location



 

Contact Information

Payment Instructions

  • Payment Policy: 
    Payment for public courses is due upon registration. Course registration is not official until payment is received. NSF International accepts Visa, MasterCard and American Express. If another method of payment is required, please contact 800-NSF-MARK, x5600. 

    Travel Arrangements: 
    Lodging and travel costs are not included in the course fee. The individual attending the course must make their own travel arrangements. 

    Cancellation/Transfer Policy: 
    Substitutions are welcome anytime; however please notify us as soon as possible to make the necessary changes 

    Early Cancellations:
     More than two weeks, prior to the course date will be issued a refund less a 25% processing charge.

    Late Cancellations: Less than two weeks prior to the course date are not issued a refund

    Program Cancellation:  NSF Health Sciences Dietary Supplement Program reserves the right to cancel or postpone a course due to unforeseen circumstances. Should this occur, you will be notified as soon as possible. All efforts will be made to notify participants at least two weeks before the scheduled events. If NSF Training & Education cancels a course, your entire registration fee will be refunded

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