GMP Compliance for Quality Control and Contract Laboratories

GMP Compliance for Quality Control and Contract Laboratories is a conference dedicated to laboratory controls relating to equipment calibration and preventive maintenance.

Topics

• 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

Who should Attend

• Quality Assurance professionals
• Laboratory scientists and managers
• Compliance professionals
• Regulatory Affairs professionals
• Anyone with management or oversight responsibility for QC Lab operations
• GMP Auditors