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Activity Provided By:

CfPA

Good Laboratory Practices (GLP)

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Overview / Abstract:

The main intent of this course is to review the requirements imposed by Good Laboratory Practices (GLP) regulations for facilities engaged in toxicology and product safety testing, primarily in animals and biological test systems. The responsibilities and functions of management including the Study Director, Principal Investigator and the Quality Assurance Unit (QAU) will be covered. Various procedures for meeting the requirements of the regulations will be presented.

The lectures will be supplemented by a question and answer session conducted by the Faculty and by workshops involving problem-solving exercises.

The course will concentrate on OECD and FDA Good Laboratory Practices and their application. This will include recent developments regarding multi-site studies and their practical interpretation. Additionally there will be sessions relating to computer validation, particularly as required by FDA in their 21 CFR Part 11 documents.

Emphasis will be placed on the practical implementation of GLP and discussion including problems that the participants bring to the course.

Expiration

May 09, 2018

Discipline(s)

Education (Higher Ed)

Format

Live / Seminar, Seminar

Cost

$2750

Credits / Hours

1.8 CEUs

Accreditation

IACET, ASQ

Presenters / Authors / Faculty

David Long; Long and Associates International Consulting Ltd.

Keywords / Search Terms

CfPA GLP, Good Laboratory Practices, contract biological testing facilities, OECD, FDA Good Laboratory Practices, 21 CFR Part 11, toxicology, product safety testing, Study Director, Principal Investigator, Quality Assurance Unit (QAU) Seminar CE CME

LIVE Activity Location Details

Date(s)
05-07-2018 - 05-09-2018

Amsterdam, The Netherlands
 
Netherlands

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