SPI USA, Inc., San Francisco, CA
September 13 and 14
* Introduction to the FDA
1. FDA Overview of the Biopharmaceutical Industry
2. FDA Organization as it pertains to the Biopharm Industry
3. Overview and History of 21 CFR Part 58
Group Discussion: Current GLP responsibilities and experiences of class participants
* GLP vs. GMP, GCP
1. GMP application
2. GCP application
3. GLP's role in the Biopharm Industry
1. GLP in the Drug Discovery Process
2. Preclinical studies
4. Drug commercialization timeline with GLP application shown
* Overview of the science of GLP
1. Categories and examples of preclinical tests
2. Preclinical Safety Studies - cell culture and animal studies * GLP Laboratory Organizatio & Function
1. Personnel
2. Qualifications
3. Study Director
4. Quality Assurance Unit
5. Facility Manager * GLP Facilities - Design and Qualification
1. Receiving and Storage
2. Laboratories
3. Animal Rooms
4. Office space - secured/safe
5. Archives
* GLP Documentation - general overview of documentation
1. Documentation Requirements in GLP Operations
1. Study protocol
2. Protocol amendments
2. SOPs vs. protocols - definitions
3. Laboratory Documentation
1. Data and Reporting
2. Raw Data
3. Electronic Data
4. GLP Study Reports
1. Required components
2. Report amendments
5. Responsibilities
6. GLP archiving
* Laboratory Deviations and Out of Specification Results
1. Definitions
2. Required Actions
3. Documentation
4. Changes and Approvals
5. Comparison of documentation to chain of custody * Testing/Laboratory SOPs
1. SOP format
2. SOP dos and dont's
3. Deviations
* Laboratory Equipment
1. Preventive maintenance
2. Calibration
3. Cleaning
* Audits
1. What to expect/how to prepare
2. Behavior during an audit
3. Follow-up actions
4. Most common deficiencies in GLP inspections
Exercise: Review of FDA 483 Citations of GLP Facilities
* Summary and Questions
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