Comparing GLP with GMP

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 Should Attend:

A must attend webinar for professionals in Pharmaceutical development and quality control companies, medical device industry, Manufacturers of drug substances (APIs) and Contract laboratories, 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

Course Director: DR. LUDWIG HUBER

Ludwig Huber, Ph.D., is the director of Labcompliance and editor of (www.labcompliance.com), the global online resource for validation and compliance. He is the author of the books “Validation and Qualification in Analytical Laboratories” and “Validation of Computerized Analytical and Networked Systems”. He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11, 21CFR Part 111 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national health care agencies. For more information, please visit Dr.Huber’s website (www.ludwig-huber.com).