Highlights of FDA GLP Regulations and the (Roles) and Responsibilities
Details
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
Outline
Special Offer
One Dial-in One Attendee
Price: $290.00
Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
