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CfPA

GLP and Quality Assurance: Developing a GLP Compliant QA Program

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Overview / Abstract:

Who Should Attend?
The participants in this course will already know the basics of GLP. The course is designed for those who wish to master how to implement and maintain a GLP QA function. The course explores quality issues within preclinical GLP and provides an opportunity for experienced personnel to update their competencies. Participants may come from:

• Life-Science Industries
• Academia
• Government
• Contract Testing Facilities

Course Description
This 2-day intensive course will explore the activities of a Quality Assurance department when auditing or inspecting studies and facilities for GLP compliance. All aspects of QA work will be discussed including; the preparation of planning documents, review of protocols and SOPs, inspection of facilities and processes, performance of inspections of on-going phases and the audit of final reports. The presenter will particularly consider the rationale to apply when developing and implementing a QA audit & inspection program. Consideration will be given to the role of QA vis-à-vis computerized systems. The reference materials will be the FDA and OECD Good Laboratory Practice Regulations and the series of monographs of the OECD relating to the interpretation of these GLP principles. Time will also be given to the setting up of quantitative techniques for the measurement of Quality, enabling participants to follow the compliance level within laboratories. Presentations will be supplemented with many interactive case studies, problem solving experiences and workshops. Emphasis will be placed on the various options available for meeting regulatory requirements.

Expiration

May 29, 2018

Discipline(s)

Education (Higher Ed)

Format

Live / Seminar, Seminar

Cost

$2280

Credits / Hours

1.2 CEUs

Accreditation

IACET, ASQ

Presenters / Authors / Faculty

David Long; Long and Associates International Consulting Ltd.

Keywords / Search Terms

CfPA GLP, Quality Assurance, OECD Good Laboratory Practice, FDA, compliance, regulatory, SOPs,

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