GMP Compliance for Quality Control and Contract Laboratories

Why Should You Attend:

This program will examine 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, and case studies focusing on a review of common laboratory inspection observations.

Areas Covered in the Webinar:

Upon completing this course participants should:

• Understand the fundamental laboratory controls mandated under US GMP regulations
• 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

David L Chesney
Principal and General Manager, DL Chesney Consulting LLC

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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