Webinar On Comparing GLP with GMP

Description :

Good Laboratory and Good Manufacturing practices are regulations that are applied during different lifecycle phases of drugs and drug substances. Both regulations have some common requirements but there are also significant differences. There are many  questions about the differences and similarities between both of them and when and how exactly to apply one or the other and how Good Clinical Practice regulations (GCPs) fit between GLP and GMP.

For easy implementation, attendees will receive:

120-page Primer: Good Laboratory Practices and Current Good Manufacturing Practices

Detailed worksheet: GLP vs. GMP Matrix

SOP: Going from GLP to GMP

Areas Covered in the Session :

Regulations along the drug lifecycle: GLP, GCP, GMP

Frequent misconceptions

Clarify objectives, the scope and applications of GLP vs. GMP

Common requirements of GLP and GMP

Key organizational differences and execution of tasks

Key documents

Going into  details of similarities/differences: procedures, personnel, equipment, methods, stability testing, reserve samples, raw data, archiving of records

Effectively moving from. GLP to GMP: step-by-Step

Expanding GMP to GLP: Step-by-Step

GLP and GMP in a single environment: what to care about

Circumstances  when research labs must comply with GMP or GLP

FDA inspections: timing, focus, enforcement in GLP vs. GMP

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:

QA Managers and Personnel

Analysts and Lab Managers

Regulatory Affairs

Training Departments

Documentation Departments

Consultants