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.
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