2016 - 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