Reading Between the Lines: Dealing with Gaps in GLP Regulations
Instructor:
Anne E Maczulak
Product ID: 700945
- Duration: 60 Min
The Good Laboratory Practice regulations instituted by the FDA in the 1970s were developed to ensure the accuracy and integrity of preclinical drug and device studies. These GLPs consist of certain simple but defined methods for assuring that test articles are safe and effective before being tested in clinical studies. This presentation reviews the major areas described in FDA 21 CFR Part 58, particularly emphasizing the five key elements of preclinical studies: written procedures, personnel, equipment, data collection, and reporting. The key roles of the QAU, study director and management are reviewed.
Areas Covered in the seminar:
- Why the GLPs were written.
- The major sections of 21 CFR Part 58.
- Protocols, amendments, and deviations.
- Good data documentation.
- The basics of an effective SOP system.
- Final report requirements.
- The principles of data and sample chain-of-custody.
Who will benefit:
This webinar is targeted to scientists and management new to GLPs. This includes established companies, startups, and university laboratories conducting sponsored regulated studies. The following individuals will benefit from the information in this webinar:
- Study directors, contributing scientists, testing facility management, and study sponsors
- QA managers and personnel
- Analysts, technicians, and other study personnel
- Consultants
- Auditors
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. Anne
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