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.
Agenda
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 Should Attend
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
