Course Description:

The cost of non-compliance with regulatory standards within the dietary supplement industry has already been big. Several firms have suffered irreparable damage to their reputations for failing to implement and maintain strong laboratory compliance and testing programs. Make sure that your organization’s laboratory compliance program is effective and tailor-made in light of the key risk factors within your organization.

This seminar will provide an overview of the importance of the role of the laboratory within your larger quality organization in implementing and maintaining a strong testing compliance program. We’ll review enforcement action case studies and discuss how they might have been prevented. We’ll also review key internal controls that can help prevent laboratory non-compliance becoming a problem during an FDA inspection.

Learning Objectives:

Key goals of this course are:

  • To provide an understanding of the regulatory requirements for dietary supplement analytical laboratories and testing best practices
  • To ensure your testing laboratory is prepared to manage according to good manufacturing practices, including 21 CFR 111 Subpart J and other applicable regulations
  • To effectively mitigate the risk of laboratory non-compliance and understand how the laboratory fits within the corporate quality assurance organization and integrates with other quality systems
  • To focus on the key internal controls that can prevent your laboratory becoming a compliance risk
  • To understand regulatory expectations of testing laboratories in the dietary supplement industry
  • The course will focus on the following key aspects of a laboratory compliance program:
    • Raw material identity testing
    • Supplier qualification
    • Specifications
    • Sampling
    • Contract laboratories and how to choose them
    • In-process and finished product testing
    • Documenting test exemptions
    • Method qualification and validation
    • Quality management oversight of laboratory operations
    • Record-keeping
    • Electronic Records and Signatures
  • To discuss key case studies and how enforcement actions could have been prevented
    • FDA Form 483 observations
    • FDA Warning Letters
    • Identity Testing by FTIR
  • To review the key concepts and implementation steps for a risk-based approach to an enterprise-wide testing compliance program

If you are looking for answer of these questions, you would certainly benefit by attending this seminar:

  • Are you struggling with the implementation and maintenance of an effective laboratory compliance program under the dietary supplement cGMP’s?
  • Is your company aware of its regulatory obligations for testing activities, and the potential impact of non-compliance?
  • Are you looking to improve the efficiency and effectiveness of your testing compliance program in light of limited resources?
  • Would you like to ensure that your company operates an effective cGMP-compliant program which meets or exceeds regulatory expectations and industry best practice standards?
  • Does your laboratory staff receive regular, targeted, GMP training?

Who will Benefit:

The following job titles/ positions will benefit from attending:

  • Dietary supplement Manufacturers
  • Distributors
  • Suppliers
  • QA/QC
  • Lab Managers
  • Technicians
  • Operations
  • R&D staff
  • Product Development
  • Formulation Personnel

Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 1:00 PM)

Registration Process: 8:30 AM - 9:00 AM

Session Start: 9:00 AM

Welcome and Introductions (30 Minutes)

  1. Overview of US Regulations Applicable to Dietary Supplement Analytical Laboratories (30 Minutes)
    1. Good Manufacturing Practices: 21 CFR Part 111
      1. Subpart D: Equipment and Utensils
      2. Subpart E: Specifications
      3. Subpart F: Quality Control
      4. Subpart J: Laboratory Operations
      5. Subpart P: Records and Record-keeping
  1. FDA Enforcement Activities To-Date (1 Hour)
    1. Compliance Risk Items for Analytical Laboratories
      1. Data from FDA Form 483 Observations and what it tells us
      2. Review of Warning Letters Related to Lab Operations
      3. Case Studies: based on Warning Letters
  1. Dietary Supplement High Risk Items: Specifications (2 hours)
    1. Setting Specifications
      1. Setting specifications that CAN be tested
      2. Testing protocols
      3. Documenting exemptions from testing requirements
      4. Review of FDA enforcement
    2. Testing Specifications
      1. Identity Testing Requirement, and exemptions
      2. Dietary ingredients vs. other components
      3. In-Process and Finish Product Testing
      4. Review of FDA Enforcement
      5. “Ingredients of interest” and why
      6. Countries having a significant level of risk of adulteration or other problems: guidance on assessing country risk
      7. Reasonably anticipated contaminants: heavy metals, micros, pesticides, drug residues, substitution and adulteration
  1. Identity Testing Case Study (1.5 hours)
    1. A study of FTIR as a method for identity testing
      1. Advantages
      2. Common pitfalls found during audits and inspections
  1. More Analytical Laboratory High Risk Items (2 hours)
    1. Reference Materials
      1. How to source and qualify valid reference materials
      2. Available resources
    2. Sampling
      1. Representative sampling, sampling protocols
      2. Requirements for reserve samples
    3. Vendor Qualification – a Laboratory Perspective
      1. Qualifying supplier certificates of analysis
      2. Review of FDA enforcement activities
    4. Methods: Validate or Qualify?
      1. Test method qualification and/or validation, as required by 21 CFR 111 cGMP’s
      2. Available resources
    5. Material Reviews and Disposition Decisions
      1. Regulatory requirements
      2. OOS investigations
      3. Role of the laboratory on the Material Review Board
    6. New Dietary Ingredients (NDI’s): To file or not to file?
      1. Filing process overview
      2. Detailed documentation required
      3. Timeliness of filing

Welcome (15 Minutes)

  1. Electronic Records and Signatures (1 Hour)
    1. Review of 21 CFR Part 11, Electronic Records and Signatures
      1. Electronic Records
      2. Electronic Signatures
      3. Evaluating laboratory computer systems for risk
      4. Current enforcement actions
  1. Choosing a Contract Laboratory (1 Hour)
    1. Qualifying a 3rd Party Laboratory
      1. ISO and Other Certifications: are they useful?
      2. Audits and check samples
      3. Laboratory Audits and Inspections, what to expect
  1. Shelf Life Dating and Stability Studies (30 minutes)
    1. Shelf-life dating of dietary supplements
      1. Regulatory requirements for Stability studies
      2. Enforcement
      3. Available resources
  1. Laboratory cGMP Training Requirement (30 minutes)
    1. Organization charts and Job Descriptions
    2. Devising an annual training plan and documenting trainings
    3. Training adequacy assessment
  1. Final Q&A/Conclusion/Wrap up session (30 minutes)

Meet Your Instructor

Marian Boardley
Consultant, Marian Boardley Consulting LLC

Marian Boardley is an independent consultant who manages projects for dietary supplement manufacturers and distributors. She helps clients in the food, drug, and dietary supplement industries to implement compliance with dietary supplement, food, and other cGMP's. She regularly trains staff to be ready for FDA inspections and also writes documentation for quality control, laboratory and manufacturing operations. Ms. Boardley spent over two years managing GMP compliance and the botanical identity program for a Utah-based dietary supplement company.

Marian is also currently a Senior Consultant with FDA Compliance Group LLC. Previously, Ms. Boardley directed financial applications development at Oracle Corporation, managing software programming and testing, speaking at user group meetings, and delivering customer training classes. As a consultant, she also served in interim management positions for web software projects, and recruited technical staff for several early internet startups. Originally trained in chemistry, Ms. Boardley spent several years at the University of Reading, England as Research Technician for Prof. J. B. Harborne, a world authority in phytochemistry, this work culminated in seven published papers describing methods of analysis and identification of flavonoid compounds. Marian Boardley was born in Yorkshire, England and is now a US citizen residing in Moab, Utah

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Local Attractions

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Located in North Houston, Old Town Spring is a community of shops, restaurants, and museums designed to resemble America during the early 1900's. Enjoy a nostalgic walk through the town's many Victorian-style antique shops, or catch a live music performance at the Jailhouse Saloon. Lodging options include two hotels and an RV resort.

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