Clearing up Roles and Responsibilities in the GLPs

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

Instructor Profile:

Anne E. Maczulak, is Principal Consultant of Acorn GLP Consulting, based in the San Francisco Bay Area. She provides FDA and EPA Good Laboratory Practice compliance audits, training, and guidance to large and small companies in pharmaceuticals, devices, biotechnology, and chemicals. She has also provided GLP guidance for university-based studies. Acorn GLP Consulting specializes in helping companies and university laboratories new to preclinical studies build strong quality assurance and GLP programs from the ground up.

Anne worked in industry for 20 years at pharmaceutical and consumer products companies. During that time she served as a GLP sponsor, study director, and participating scientist.

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