Laboratory Compliance 2012 - 2-day In-person Seminar: Good Laboratory Practice (GLP) for Non-Clinical Laboratory Studies - Application and Compliance to Ensure Safety of Biologic Therapeutics and Medical Devices

The design and establishment of the laboratory facility, test methods and materials handling are impacted by stringent guidelines defined by regulatory agencies including the Food and Drug Administration (FDA), International Conference on Harmonization (ICH) and represented as Good Laboratory Practice (GLP) regulations delineated in 21 CFR Part 58. An additional component of a preclinical development program is the necessity of periodic internal and external audits of the facilities to ascertain the enforcement and consequent adherence of quality policies.

Topic Background:

The basic premise of Good Laboratory Practice (GLP) is to monitor universities, contract laboratories and biopharmaceutical companies that conduct animal and clinical studies to ensure the quality and authenticity of drug safety information. These GLP requirements were established by regulatory authorities in the 1970s following inspections of institutions that revealed appalling animal testing conditions and deceptive data reports submitted for FDA approval.

Who will Benefit
- Executive management
- R&D investigators
- Product development
- Pre-clinical and clinical
- Regulatory affairs
- QA/ QC
- Marketing
- Consultants
- Training