This GLP (Good Laboratory Practices) webinar presents a straightforward summarization of the roles and responsibilities of all the people that contribute to a GLP study.
It emphasizes the three required elements: study director, management, and QAU (Quality Assurance Unit). It also reviews the main mistakes that FDA sees continually in inspections. The webinar also lists the roles and responsibilities of participating scientists, archivists, and sponsors. It clarifies the signature/approval process. Finally, this webinar covers difficult situations between sponsor-management and sponsor-study director..
It emphasizes the three required elements: study director, management, and QAU (Quality Assurance Unit). It also reviews the main mistakes that FDA sees continually in inspections. The webinar also lists the roles and responsibilities of participating scientists, archivists, and sponsors. It clarifies the signature/approval process. Finally, this webinar covers difficult situations between sponsor-management and sponsor-study director..
Areas Covered in the seminar:
- Key personnel in a GLP(Good Laboratory Practices)study.
- The main roles of key personnel.
- Management.
- Study director and principal investigators.
- Study personnel, participating scientists, and archivist.
- Sponsors.
- Clearing up confusion in roles and responsibilities.
Who Will Benefit:
This Good Laboratory Practices training targets people who have experience in GLP studies. It intends to correct some of the common mistakes even experienced personnel have when it’s time to plan, conduct, and report on studies. It puts emphasis on managing situations in which people overstep their roles or do not meet their responsibilities. This content is best suited to:- Management
- Study directors
- Principal investigators
- Study scientists
- QA representatives
- Sponsor
Course Provider
Anne E Maczulak,
