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| Good Manufacturing Practices (GMPs) |
| A-01. GMP Compliance |
- GMP Origin
- Reasons for Compliance
- Review the Major Requirements of Each Subpart
- The Five Major Objectives of GMP Compliance
- How to Comply With GMPs
- How to Comply With GMPs
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Level: B
Approx. Time: 90 min. |
| A-02. GMP Interpretations |
- Basic Rules for Interpreting GMP Requirements
- FDA References for GMP Interpretations
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Level: A
Approx. Time: 45 min. |
| A-03. GMP Documentation and SOP Requirements |
- Review Basic Elements for GMP Documentation
- Recommendations for Level of Details in SOPs
- Requirements for Second Person Checking
- Review the Interpretations for Selected GMP Records
- Discussion of Recordkeeping Deficiencies to Avoid
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Level: B
Approx. Time: 75 min. |
| A-04. GMP Requirements for Sterile Products |
- Basic Requirements for Sterile Products
- Environmental Requirements and Controls
- Aseptic Filtration
- Terminal Sterilization
- Depyrogenation
- Time Limitation
- Validation
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Level: B
Approx. Time: 2 hrs. |
| A-27. Sterile Drug Products Produced by Aseptic |
- Revised Guidance, 9/2004 - review of selected revisions
- Environmental classifications, requirements and monitoring
- Media fills
- Isolators
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Level: A
Approx. Time: 30 min. |
| A-25. Aseptic Techniques and Training |
- Generation of Particulates
- Interruption of Laminar Flow
- Contamination Control
- FDA Guidance
- Cleanroom Behavior
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Level: B
Approx. Time: 45 min. |
| A-09. GMPs for Active Pharmaceutical Ingredients |
- Departmental Responsibilities
- Second Person Checks
- Equipment Qualification
- Raw Material Control
- Productions, Packaging and Distribution
- Laboratory Controls
- Product Annual Review
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Level: A
Approx. Time: 60 min. |
| A-10. GMP for Executive Management |
- GMP Objectives
- GMP Interpretations
- Current Compliance Issue
- FDA Expectations for Executive Management
- Management Responsibilities
- Management Support for Compliance
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Level: A
Approx. Time: 2 hrs. |
| A-16. GMP Requirements for Calibration and Maintenance |
- GMP Requirements
- Recommendations for Program Implementation
- Calibration and Maintenance Records
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Level: B
Approx. Time: 90 min. |
| A-20. GMP Requirements for Buildings and Utilities |
- Basic GMP Review
- Requirements for Facilities
- Requirements for Systems and Utilities (HVAC, dust collection, compressed air, water)
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Level: B
Approx. Time: 60 min. |
| A-05. Label Controls |
- Master Label Controls
- GMP Requirements for Packaging and Labeling
- GMP Compliance Interpretations for Labeling Controls
- Proposed GMP Revisions for Cut Labeling
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Level: B
Approx. Time: 60 min. |
| A-24. Compliance Review for Change Control Program |
- FDA Expectations and Compliance Issues
- Basic Elements
- Documentation Requirements
- Evaluation of Changes
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Level: A
Approx. Time: 45 min. |
| A-15. U.S. vs. Barr Laboratories |
- Laboratory Retest Policy
- Manufacturing Controls
- Failure Investigations
- Cleaning Validation
- Manufacturing Process Validation
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Level: A
Approx. Time: 45 min. |
| E-09. FDA Compliance/Inspection Trends and Issues |
- Drug Recalls
- FDA Compliance and Enforcement Trends
- FDA Inspection Programs and Trends
- CBER Enforcement and Inspection Trends (where available)
- Recent GMP Interpretations (where available)
- New/Proposed Regulations and Guidance
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Level: A
Approx. Time: Up to 3 hrs. (based on selection of topics) |
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