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2-Day Course
Cost-Effective Implementation of Dietary Supplement cGMPs

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A step by step guide for following the current FDA regulations

This program provides Professionals in the dietary supplement environment, a complete, up to the minute examination of the current FDA regulations that are now in effect, how to accurately interpret the legislation and how to properly manage, document and respond to this regulation.  You will have all the key information and direction you need to get both employees and management onboard.  The program provides a step by step discussion of each requirement, and how to manage the and  report the more complicated issues as well, such as establishing requirements for all types of materials and components.  This program will provide and meet cGMP training credit.

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Course Outline

Course Overview and Learning Objectives

Speaker Qualifications

General Overview of Dietary Supplement Regulations

• The Dietary Supplement Health and Education Act (DSHEA)
• What are cGMPs?
• FDA Interim Final Rule
• FDA Final Rule
• Compliance Phase-in Period

Who Needs to Comply?

• Manufacturers
• Packagers, Repackagers, Labelers
• Sell in Bulk to a Distributor
• Importers

Why are cGMPs Needed?

• Consumer Benefits
• Examples of Quality Problems

Getting Started

• Final Rule Organized into 16 Subparts
• Manufacturing Process
• Quality Issues

Subpart B – Personnel

• Preventing Contamination
• Personnel Qualifications
• Supervisor Qualifications
• Required Records

Subpart C – Physical Plant and Grounds

• Sanitation Requirements for Physical Plant and Grounds
• Design and Construction Requirements
• Required Records

Subpart D – Equipment and Utensils

• Establishing and Following Written Procedures
• What Requirements Apply to Equipment and Utensils
• What Requirements Apply to Automated, Mechanical or Electronic Equipment
• Required Records

Subpart E – Production and Process Controls

• Requirements to Implement a Process
• Design Requirements
• Requirements for Quality Control Operations
• Establishing Specifications
• Responsibility for Determining Whether Specifications are Met
• What Happens When Specifications are not Met?
• Representative Sampling
• Reserve Sampling
• Material Reviews and Disposition Decisions
• Reprocessing and/or Handling Deviations
• Required Records

Subpart F – Requirements for Quality Control

• Quality Control Personnel Requirements
• Laboratory Operations
• Quality Control and Material Review and Disposition Decisions
• Equipment, Instruments and Controls
• Components, Packaging and Labeling
• Master Batch Records
• Packaging and Labeling Operations
• Returned Goods
• Product Complaints
• Required Records

Subpart G – Requirements for Components, Packaging and Labels

• Components
• Packaging and Labeling
• Products Received for Packaging or Labeling
• Rejected Packaging and Labeling
• Required Records

Subpart H – Requirements for Master Manufacturing Record

• What are Master Manufacturing Records?
• What Must They Include?

Subpart I – Requirements for Batch Production Record

• What is a Batch Production Record?
• What Must it Include?

Subpart J – Requirements for Laboratory Operations

• Requirements for Laboratory Facilities
• Requirements for Laboratory Control Processes
• Requirements for Test Methods
• Required Records

Subpart K – Requirements for Manufacturing Operations

• Requirements for Design and Specifications 
• Adequate Sanitation Principles
• Preventing Contamination
• Handling Rejected or Unsuitable Dietary Supplements
• Required Records

Subpart L – Requirements for Packaging and Labeling Operations

• Requirements for Packaging and Labeling
• Requirements for Filling, Assembling, Packaging, Labeling and Related Operations
• Requirements for Repackaing and Relabeling
• Handling Rejected Packaged and/or Labeled Dietary Supplements
• Required Records

Subpart M – Holding and Distribution

• Requirements for Holding Components, Labeling, Packaging and/or Dietary Supplements
• Requirements for Holding In-Process Materials
• Requirements for Holding Reserve Samples
• Distribution Requirements
• Required Records

Subpart N – Requirements for Returned Dietary Supplements

• Requirements for Returned Goods
• When Must Returned Good be Destroyed?
• When May Returned Goods by Salvaged?
• Requirements for Reprocessing Returned Goods
• When Must Investigations be Conducted?
• Required Records

Subpart O – Product Complaints

• Reviewing and Investigation Product Complaints
• Required Records

Subpart P – Records and Recordkeeping

• Requirements for Recordkeeping
• Requirements for Making Records Available to FDA
• Summary – Making it All Work Together
• Getting Management On-Board
• Getting Employees On-Board

cGMP Training Credit

• Competency Assessment Performed to Ensure All Attendees Fully Understand All Concepts Presented and Can Implement Them Before the End of the Training Course
• Documented Training Verification Provided Using Our Own Training Forms or Your In-House Training Form To Address FDA’s Requirement of Periodic cGMP Training

Free 1 on 1 Consulting From the Industry’s Top Expert

• Confidential One On One Consulting/Assistance at the End of the Course For Those That Sign Up In Advance at No Additional Cost.
• Get Answers to your Specific Situation Questions Without Airing your Firms “Laundry” to the Group.

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Who Should Attend

This two day program is an ideal comprehensive introduction to “need to know” topics for:

• Dietary Supplement Developers and Manufacturers
• CEOs
• Presidents
• Managers
• Director of Quality and Regulatory affairs
• Legal counsel
• Taining personnel