This webinar will cover the requirements for laboratory controls under US GMP regulations, such as those 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.
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
Course Content
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.
Speaker
David L ChesneyCourse Provider
David L Chesney,
