Webinar On Good Laboratory Practice Regulations - Introduction and Strategies for Implementation

Event Details

Time: February 19, 2015 from 1pm to 2:15pm
Location: Online
Street: 5939 Candlebrook Ct
City/Town: Mississauga
Website or Map: https://compliancetrainings.c…
Phone: 4169154458
Event Type: webinar
Organized By: complianceTrainings
Latest Activity: Jan 16, 2015

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Event Description

Description :

Complying with GLP regulations can increase the cost of a laboratory up to 30%. Companies or employees either don't know exactly what GLP really means, or what procedures are required and how to implement GLP regulations. Lack of GLP knowledge is also an inspection issue as training plans should include basic GLP knowledge for everybody working in a GLP environment. Attend the seminar to get a good understanding on GLP regulations and get best practice guides and strategies for easy implementation.

Areas Covered in the Session :

FDA and International GLP regulations: 21 CFR Part 58, OECD

Examples for FDA 483 inspectional observations and warning letters

Objectives, scope and concepts of GLP's

Special organizational requirements

Responsibilities: Management, Study director, QA, analysts

SOP requirements: type, formats and enforcement

GLP studies: preparation, conduct, documentation

Key requirements for equipment, facilities reference material, people

Data generation and evaluation: raw data, intermediate results, final results

Records keeping: format, length of time, archiving and reprocessing

Strategies for Multi-site GLP Studies