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Date: 15th - 16th May, 2008

Location: Dublin, Ireland

Summary:
Pharmaceutical - Training

This two-day course is designed for all Scientists (managerial, production and laboratory), Regulatory Affairs and Compliance personnel. It will be of most benefit to personnel in an environment whose job function necessitates the generation, evaluation and assurance of data from pre-clinical studies. Professionals responsible for the submission of regulatory filings with the US FDA and corresponding organizations overseas will also find this course useful. Those new to the pharmaceutical industry and experienced staff who need refresher training will benefit. This course is also useful for quality assurance and quality control managers, regulatory affairs professionals, auditors, production managers and management interested in effective QA techniques.

LEARNING OBJECTIVES
By the end of the course, attendees will have a strong understanding of the fundamental compliance requirements for current Good Laboratory Practice and Good Manufacturing Practice guidelines, and be able to apply compliance protocols in all efforts aimed at generating regulated data. All participants will gain a fundamental understanding of the basis of the regulations, the necessity of rigorously implementing them in their groups and incorporating this regimen and proactive thinking in all scientific matters. The consequences of non-compliance will be exemplified.

COURSE DESCRIPTION
This course will provide participants with an understanding of the terminology and mandated practices for GLP/GMP testing and compliance. The course will review regulations, as well as, current issues involving International Harmonization. Those attending will get a thorough understanding of the relevance of accurate documentation, calibration of instruments and validation of methodology. Special attention will be paid to the critical compliance aspects of gathering pre-clinical data in a regulated environment.

Also included is a discussion of functions related to Quality Assurance responsibilities and the need to effectively audit for regulatory compliance. Successful audits are often a result of good planning and interaction between QA staff and management. This course will cover a range of audit activities (internal and external) including responsibilities and requirements for compliance even at collaborator sites, records management, GLP special requirements, archiving of data, and inspections.