2016 - 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