Webinar on GLP Regulations - Introduction and Strategies for Implementation

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.

For easy implementation, attendees will receive:

Good Laboratory Practices and Current Good Manufacturing Practices: 120 pages e-book

Gap Analysis/Checklist: Good Laboratory Practice Regulations

SOP: Archiving GLP Data and Other Documents

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

Preparing for FDA inspections

Who Will Benefit:

A must attend webinar for professionals in Pharmaceutical and medical device industry, Manufacturers of drug substances (APIs) and Contract laboratories, Contract manufacturing organizations, Clinical research organizations. The teams that will benefit the most are:

Lab Supervisors and Managers

QA Managers and Personnel

GLP Auditors

GLP Study Directors

Analysts

Consultants

Teachers

Everybody getting involved in GLP studies

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

For more information about this event please visit

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