GMP Compliance for Quality Control and Contract Laboratories (COM)

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Philadelphia, PA 19103

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GMP Compliance for Quality Control and Contract Laboratories

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 Objectives:
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


Day 01(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 02(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


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

David L. Chesney is the Principal and General Manager of DL Chesney Consulting, LLC.

His career includes 23 years with the FDA and over 21 years in GMP and GCP consulting worldwide. In his consulting practice, Mr. Chesney helps clients prevent quality and compliance problems through proactive assessment and planning, and when necessary, with remediation planning and health regulatory authority communications.

Until recently, he served as Vice President, Strategic Compliance Services for PAREXEL Consulting, a business unit of PAREXEL International LLC. Prior to joining PAREXEL Consulting in 1995, Mr. Chesney served 23 years with the FDA, where he advanced from Investigator to Supervisory Investigator and Director, Investigations Branch, working in the Boston, Seattle and Philadelphia District Offices. In 1991, he was appointed the District Director, FDA San Francisco District Office, where he served until joining PAREXEL in 1995. For 19 years, he led the Strategic Compliance Consulting group, and also personally provided regulatory enforcement related consulting services to the pharmaceutical, medical device and biologics industries, plus technical assistance to legal counsel in FDA regulatory matters. Mr. Chesney has a bachelor's degree and postgraduate credits in biology from California State University, Northridge and San Diego, and received a Certificate in Health Care Compliance from Seton Hall University School of Law.

Please contact the event manager Marilyn (marilyn.b.turner(at) ) below for:
- Multiple participant discounts
- Price quotations or visa invitation letters
- Payment by alternate channels (PayPal, check, Western Union, wire transfers etc)
- Event sponsorships

Prices may go up any time. Service fees included in pricing.
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Philadelphia, PA 19103

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