GMP Compliance for Quality Control and Contract Laboratories: 2-Day In-Person Seminar by Ex-FDA Director

By: David L. Chesney, Principal and General Manager, DL Chesney Consulting, LLC (Former FDA Director)
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Course Description:

This program will cover the requirements for laboratory controls under US GMP regulations and compare them to those applied by other international health regulatory authorities. Laboratory controls relating to equipment calibration and preventive maintenance; sample chain of custody; good documentation practices; investigation of out of specification and out of trend results; analytical method validation; change control; impact of staffing levels and work flow patterns in the lab on GMP compliance; training and other issues will be included under laboratory controls. The program will also examine the impact of the benchmark court ruling in US versus Barr Laboratories on QC laboratory governance under GMP; the role of the QC Laboratory; its placement in the overall organizational structure of a company; the responsibility of a contract laboratory versus an in-house laboratory; regulatory requirements and expectations concerning the relationship between a contract laboratory and the company who gives the contract; the criticality of data integrity, with special emphasis on recent laboratory related issues that have arisen internationally, and case studies focusing on a review of common laboratory inspection observations.

Learning Objective:

Upon completing this course participants should:

  • Understand the fundamental laboratory controls mandated under US and various other international GMP regulations
  • Understand the global influence of the landmark US versus Barr Laboratories case, why it matters outside of the United States, what the original objective of the ruling was and how its influence has spread internationally and impacted laboratory GMP governance world wide
  • Understand the principles of investigation of out of specification and out of trend results and why they are important to GMP compliance
  • Understand the expectations of regulatory authorities about the organizational placement of the QC lab and its relationship to QA and Manufacturing units
  • Understand the expectations of regulators regarding contract givers and contract receivers in outsourced laboratory operations and how those should be managed under GMP
  • Appreciate the importance of maintaining rigorous data integrity standards, particularly regarding laboratory computer systems; know the problems and pitfalls to avoid, understand the implications of the use of metadata and what to do with audit trails for computer systems

Who will Benefit:

This course is designed for people tasked with developing, maintaining and/or improving Quality Management Systems for laboratory operations, working in or managing QC laboratories, or for qualifying and auditing contract laboratories.

  • Laboratory scientists and managers
  • Quality Assurance professionals
  • Regulatory Affairs professionals
  • Compliance professionals
  • GMP Auditors
  • Anyone with management or oversight responsibility for QC Lab operations

Course Outline

Day One (8:30 AM – 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Introductions and setting of attendee’s objectives – What do you want to get from this seminar?
  • Basics of FDA law and regulations for QC laboratories
    • Concept of “adulteration” under the law as applied to:
    • Pharmaceuticals
    • Biologics
    • Medical Devices
    • Foods
    • Cosmetics
  • What is “CGMP” and how does it apply to:
    • Pharmaceuticals
    • Biologics
    • Medical Devices
    • Foods
    • Cosmetics
    • What is “GLP”?
    • What is the “AIP”?
    • Use of Contract Laboratories
    • Reliance on Certificates of Analysis
    • Quality agreement guidance from FDA
    • Monitoring and auditing laboratory performance
  • Laboratory Organization
    • Organization and reporting structure: Requirements versus “expectations”
    • Personnel qualification and training
  • Documentation and record-keeping requirements
    • Standard Operating Procedures
    • Analytical Methods
    • Raw data (notebooks, print-outs)
    • Document management (change control, retention)
    • Part 11 (electronic records and signatures)
    • Sample integrity requirements
  • Sample collection
  • Sample delivery, handling, disposition
  • Retain samples
  • Day Two (8:30 AM – 4:30 PM)
  • Check in from day one: Compare topics covered to attendee objectives stated on day one
  • Stability (shelf-life) studies
    • Organization and management of the stability program
    • Storage units
    • Stability indicating methods
  • Analytical method validation
    • Validation Protocols
    • Tests
    • Documentation
  • Management and control of laboratory instruments
    • Qualification
    • Calibration
    • Maintenance
  • Management and control of laboratory supplies
    • Standards
    • Reagents, chemicals
  • Proper conduct of laboratory out of specification/out of trend investigations
    • Out-of-specification results
    • Out-of-trend results
    • Root cause analysis
    • Documentation practices and data integrity
  • Consequences of laboratory non-compliance – enforcement basics
  • Final Q&A and open discussion
  • Meet Your Instructor

    David L. Chesney
    David L Chesney
    Principal and General Manager, DL Chesney Consulting, LLC (Former FDA Director)

    David L. Chesney, MSJ, is the Principal and General Manager for DL Chesney Consulting, LLC, providing GMP and GCP compliance consulting and training services to clients world wide. He has 47 years experience, evenly divided between the FDA and the private sector, including over 20 years as Vice President, Strategic Compliance Services for PAREXEL Consulting. Prior to joining PAREXEL Consulting, he served 23 years with the FDA as an Investigator, Supervisory Investigator, Director of Investigations and ultimately as District Director in San Francisco, managing all FDA operations in Northern California, Nevada and Hawaii.

    Mr. Chesney has an MS degree in Jurisprudence, concentrating in Pharmaceutical and Medical Device Law from Seton Hall University School of Law, a Bachelor's degree in Biology from California State University, Northridge, plus three years of graduate study in Biology at CSU Northridge and CSU San Diego. Mr. Chesney is a member of the Parenteral Drug Association, where he serves on the faculty of the PDA Training and Research Institute. He is also active in the Food and Drug Law Institute and RAPS.

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