Good Laboratory Practices (GLPs) vs GMPs - Comparisons and Contrasts 2019

Topics

• GLP as an FDA regulation
• Understanding good laboratory practices (GLP)
• History of GLPs
• Definition of GLPs
• Objectives of GLPs
• Why were GLPs created?
• The objective of GLPs and how are they associated with GMPs and SOPs
• Mission of GLPs
• Instrumentation validation
• Statistical procedures for data evaluation
• Documentation and maintenance of records
• Analytical and laboratory certification
• Grounds for disqualification
• Consequences of noncompliance
• References
• Reinstatement of a disqualified facility

Who should Attend

• Quality Assurance Departments
• Regulatory Affairs Departments
• Research and Development Departments
• Quality Control Departments
• Operations Departments
• Manufacturing Departments
• Documentation Departments
• Production Departments
• Project Managers
• Validation Teams
• Internal Auditing Personnel
• Engineering Departments
• Laboratory Personnel
• Microbiology Personnel