Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)

Why Should You Attend:

Good Laboratory Practices (GLPs), CFR part 58, are a set of guidelines for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products such as food and color additives, human and animal drugs, medical devices for human use, biological products and electronic products that are regulated by the FDA.

GLPs are not enforceable by law. They do not include manufacturing of product. GLPS are for non-clinical laboratory studies in which tests article are studied in test system under laboratory conditions to determine their safety. This does not include studies utilizing human subjects, or clinical studies, or field trials on animals.

Key Learning Objectives:

• What are Good Laboratory Practices
• Why were they created
• What is the objective of GLPs and how are they associated with GMPs and SOPs
• Statistical procedures for data evaluation
• Instrumentation validation
• Analytical and laboratory certification
• Documentation and maintenance of records
• Consequences of noncompliance
• Disqualification and reinstatement

Areas Covered in the Webinar:

• GLP: Good Laboratory Practice
• GLP is an FDA Regulation Training
• Definition of GLPs
• History of GLPs
• Why was GLP Created?
• Objectives of GLP
• Mission of GLP
• Instrumentation Validation
• Analyst Certification
• Laboratory Certification
• Grounds for Disqualification
• Consequences of Noncompliance
• Reinstatement of a Disqualified Facility

Who Will Benefit:

• Quality Assurance Personnel
• Quality Control Personnel
• Research and Development Personnel
• Regulatory Affairs Personnel
• Project Managers
• Manufacturing Managers
• Validation Engineers
• Internal Auditing Personnel
• Microbiology Personnel
• Auditors