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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. This seminar will have all the answers.
Topics to be Covered:
- 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 required by the FDA
- 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
- QC managers
- QA managers and personnel
- Laboratory managers and supervisors
- Regulatory affairs
- Training departments
- Documentation department
- Small, midsize and large Pharmaceutical companies
- API manufacturers
- Contract laboratories
- Clinical testing laboratories
- GLP facilities
- Medical device industry
Ludwig Huber, Ph.D., is the director and editor of Lab 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 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China CFDA, ISPE, PDA, PIC/S and several other industry organizations and national health care agencies.