ComplianceOnline

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.

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

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
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Day 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Introductions
    • Instructor
    • Participants
    • Determination of participant’s desires and expectations for the session
  • Recap of basic GMP principles
  • Laboratory controls overview
    • Elements of the US GMP
    • Comparison to EMA and other international requirements
    • Role of regulations versus guidelines
    • Key internet information sources
  • Where does the QC Lab fit in? - Organizational placement of the Lab and its importance to GMP compliance
  • Laboratory management impact on GMP: Importance of staffing level and workflow prioritization
    • Establishing metrics for assessing laboratory GMP compliance
  • A historical lesson: Review of the landmark US versus Barr Laboratories case and why it is important for us today
    • Context of the case
    • Overview of the court ruling with emphasis on impact on laboratory GMP
    • International reaction to the case
    • Guidelines and requirements that trace their roots to the case
  • Investigation of out of specification (OOS) results: A Barr Laboratories case legacy with worldwide laboratory GMP impact
    • US and other agencies requirements and expectations today
    • Case examples of improper OOS investigation: Implications
  • Contracting with outsourced laboratories – GMP Considerations
    • Quality Agreements (aka Technical Agreements)
    • Qualification of the lab
    • Vendor management auditing on an ongoing basis
  • Adjourn for day – 4:30 PM (1630)
Day 02(8:30 AM - 4:30 PM)
  • Back to Basics: Review of Key Laboratory GMP elements
    • Physical layout and equipment placement
    • Environmental control
    • Specifications
    • Procedures – emphasis on method description
    • Equipment qualification and analytical method validation
    • Bringing compendial methods into the lab for the first time
    • Method validation parameters typically measured
    • Raw material testing – prohibition on “conditional release” under US GMP
    • In process testing – different policy on conditional release and rationale for that
    • Documentation practices
    • Calibration and PM
    • Non-OOS laboratory procedural deviations
  • Stability program considerations
    • Stability indicating methods
    • Importance of test intervals
    • Stability chamber maintenance
    • Stability program management
  • Data integrity considerations
    • Raw data definition
    • Problems associated with use of scrap paper and other unofficial data recording
    • Computer system considerations related to data integrity
    • Case studies of laboratory data integrity lapses
  • Training issues
  • Laboratory regulatory inspections – How to know what to expect in order to better prepare
    • FDA
    • EMA
    • TGA
    • Others
  • Final Q&A, Wrap up session
  • Adjournment – 4:30PM (16.30)
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David L Chesney

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.

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