GLP Regulations and the Roles and Responsibilities in a GLP Facility

Overview:

This 3 hour GLP virtual seminar will discuss various GLP regulations (FDA/OECD GLP's) along with highlighting roles and responsibilities of management and key personnel involved in drug development, safety & toxicity evaluation and QAU function in GLP testing facilities.

Why should you Attend: This 3 hour GLP Webinar will cover some of the major requirements, definitions and elements of the various GLP regulations, and the FDA/OECD GLP's. it will discuss the strategies to apply in effective implementation of a compliant GLP program with involvement and interactions and Case Studies and group exercise included in this highly interactive course presentation.

It also aims at scoping out the Roles and Responsibilities of the Study Director, Management ,supervisors, scientists, investigators ,Regulatory , QAU and other personnel in GLP facilities, Contract Laboratories, Research Institutes or other organizations engaged in the conduct of GLP (FDA, FIFRA, OECD, JAPAN) studies and other non-clinical studies related to Drug Development, Safety & Toxicity evaluations and QAU function in GLP testing facilities.

Comparison and differences between the FDA and OECD GLP's will also be included. Real life examples and case studies will be included in this highly interactive presentation.

Areas Covered in the Session:

• Introduction: Background of GLP's
• Quality System Perspectives
• Organization and Personnel
• QAU: Audits and Responsibilities
• Facilities
• Study Conduct
• Protocols
• Equipment and Systems
• Reagents and Solutions
• Test and Control Articles
• QAU: Audits and Responsibilities
• Final Reports
• Comparisons: FDA/FIFRA GLP's
• Enforcement Actions: Disqualification and Suspension
• From Abstract doc

Who Will Benefit:

• Study Directors
• Managers
• Supervisors
• Validation Managers
• GLP Coordinators
• QAU Personnel
• Lab Personnel

Speaker Profile
Dr. Shib Mookherjea is a globally acclaimed speaker and consultant and has extensive experience in R&D, quality assurance, and quality management and teaches Methods Development, Validation Procedures, and Conformity Assessment in the Analytical Laboratory; Qualification and Validation of Laboratory Instruments and Equipment for Regulatory and QS Compliance (IQ, OQ, PQ); and the webcast Cleaning Validation and Compliance Issues for Pharma, Biotech and Medical Device Industries.