GMP Compliance for Quality Control and Contract Laboratories is a conference dedicated to laboratory controls relating to equipment calibration and preventive maintenance.
GMP Compliance for Quality Control and Contract Laboratories covers topics such as:
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
The fundamental laboratory controls mandated under US and various other international GMP regulations
The expectations of regulatory authorities about the organizational placement of the QC lab and its relationship to QA and Manufacturing units
The principles of investigation of out of specification and out of trend results and why they are important to GMP compliance
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
The expectations of regulators regarding contract givers and contract receivers in outsourced laboratory operations and how those should be managed under GMP
GMP Compliance for Quality Control and Contract Laboratories brings together:
Quality Assurance professionals
Laboratory scientists and managers
Regulatory Affairs professionals
Anyone with management or oversight responsibility for QC Lab operations
GMP Compliance for Quality Control and Contract Laboratories will be held in Philadelphia, PA, United States on 19-20 August 2019.