Good Laboratory Practices for Pre-Clinical Testing, Compliance, QA & Audit

This two-day course is designed for all Scientists (managerial and laboratory), Regulatory Affairs and Compliance personnel whose job function necessitates the generation, evaluation and assurance of data that will be incorporated in regulatory filings with the FDA and similar organizations. It will also benefit technicians and other professionals who are new to the pharmaceutical industry and those who need refresher training. This course is also useful for quality managers, auditors, production managers and management interested in effective QA techniques.

Learning Objectives

Employees involved in assuring that Good Laboratory Practice guidelines are in effect within their organization, and are being complied with in all efforts aimed at generating regulated data. All participants will have a fundamental understanding of the regulations, the necessity of rigorously implementing them in their groups and incorporating this thinking in all scientific matters. Consequences of non-compliance will be exemplified.

Course Description

This course will provide participants with an understanding of terminology and acceptable practices GLP testing and compliance. The course will review regulations, as well as, current issues involving International Harmonization. Those attending will get an understanding of the needs for thorough documentation.
Also included is a discussion of functions related to Quality Assurance responsibilities and the need to effectively audit for GLP compliance. Successful audits are often a result of good planning and interaction between QA staff and management. This course will cover the entire range of audit activities including, responsibilities and requirements of GLP, records management, GLP special requirements, electronic records, operation of the archive, inspections, moving from compliance to business improvement.