Compliance Trainings, Online
2015-11-19
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
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