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GLP (FDA-FIFRA) Regulations – Roles and Responsibilities in a GLP Facility
This Webinar is over| Date | Aug 9, 2018 |
| Time | 03:00 PM EDT |
| Cost | $15755.00 |
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Online
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This 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 :
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: Quality, Quality Systems
- Global Scenario, Harmonization, ICH
- Requirements of Quality Systems
- Genesis of FDA GLP
- Basic Definitions and Tenets of the GLP’s
- Management
- Study Director
- QAU Roles & Responsibilities
- Testing Facility: Definition and Requirement
- Equipment: Various Equipment, Devices and Instruments
- Protocol and Study Conduct
- Study Conduct: Test Systems, Test in Control Articles
- Systems and Procedures: Qualification and Validation
- Computer Systems: Risk Assessment, ERES, Validation
- Records: Storage and Retrieval: Archiving
- Retention, Requirements
- Implementation of GLP in a Testing Facility: Documentation, SOPs Case Studies and Group Exercise
- References, Web Addresses, Sources
- Comparisons: FDA/FIFRA GLP’s
- Enforcement Actions: Disqualification and Suspension
- From Abstract doc.
- Conclusion
- Study Directors
- Managers
- Supervisors
- Validation Managers
- GLP Coordinators
- QAU Personnel
- Lab Personnel
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