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Level A
Training modules and courses include advanced or technical information, and is suitable for all levels of plant personnel.
Level B
Training modules and courses are prepared specifically for operators and technicians. Some of the information may be too basic for higher level personnel. Supervisors are encouraged to attend Level B programs with their employees to show support for the training, and to answer specific questions relating to their departmental operations.
A-01. GMP Compliance
- GMP Origin
- Reasons for Compliance
- Review the Major Requirements of Each GMP Subpart (A-K)
- The Five Major Objectives of GMP Compliance
- How to Comply With GMPs
Level: B | Approx. Time: 90 min.
A-02. GMP Interpretations
- Basic Rules for Interpreting the GMP Requirements
- FDA References for GMP Interpretations
Level: A | Approx. Time: 45 min.
A-03. GMP Documentation and SOP Requirements
- Review the Basic Elements for Good Documentation Practices
- Controls for Raw Data
- Requirements for Personnel Identification and Second Person Checking
- Data Integrity
- Recordkeeping Deficiencies to Avoid
- Recommendations for SOPs
- Significance and Consequences of Poor Recordkeeping and Documentation
Level: B | Approx. Time: 90 min.
A-29. Data Integrity
- FDA Enforcement Statistics
- FDA Inspection Techniques
- FDA & MHRA Guidances and Suggestions
- Data Integrity Compliance Issues
- Examples of Recent FDA Warning Letter Citations
Level: A | Approx. Time: 2 hrs.
A-16. GMP Requirements for Calibration and Maintenance
- GMP Requirements
- Recommendations for Program Implementation
- Calibration and Maintenance Procedures and Records
- Change Control for Maintenance
- Equipment Requalification
Level: B | Approx. Time: 90 min.
A-20. GMP Requirements for Buildings and Utilities
- GMP Regulations Review
- Requirements for Facilities
- Design Requirements for Systems and Utilities (HVAC, dust collection, compressed air, water)
Level: B | Approx. Time: 60 min.
A-05. Label Controls
- Master Label Controls
- GMP Compliance Interpretations for Labeling Controls
- GMP Requirements for Packaging and Labeling Operations
- GMP Interpretations for Labeling GMP Revisions (March 2012)
Level: B | Approx. Time: 75 min.
A-24. Compliance Review for Change Control Program
- FDA Expectations and Compliance Issues
- Essential Elements for Change Control Program
- Documentation Requirements
- Review and Evaluation of Proposed Changes
Level: A | Approx. Time: 45 min.
A-04. GMP Requirements for Sterile Products
- Basic Requirements for Sterile Products
- Environmental Requirements and Controls
- Aseptic Filtration
- Terminal Sterilization
- Depyrogenation
- Time Limitation
- Employee Training for Aseptic Gowning and Techniques
- Validation
Level: B | Approx. Time: 2 hrs.
A-27. GMP Compliance Issues for Aseptic Processing
- Review New and Controversial FDA Requirements and Interpretations for Aseptic Processing
- Facilities Design
- Raw Material Controls
- Equipment Control and Maintenance
- Environmental Monitoring
- Sterilization Validation
- Media Fill Validation
- Isolator and RABS
- Aseptic Processing GMP Compliance Issues
Level: A | Approx. Time: 60 min.
A-25. Aseptic Techniques
- Aseptic Area Personnel Behavior and Movements
- Maintaining Uni-directional Airflow
- Sanitization/Disinfection Requirements
- Aseptic Gown and Gloves Controls
- Aseptic Area Access Control
Level: B | Approx. Time: 60 min.
A-09. GMPs for Active Pharmaceutical Ingredients: A Comparative Review
- Departmental Responsibilities
- Second Person Checks
- Equipment Qualification
- Raw Material Control
- Productions, Packaging and Distribution
- Laboratory Controls
- Product Annual Review
Level: A | Approx. Time: 60 min.
A-15. U.S. vs. Barr Laboratories
- Laboratory Retest Policy (OOS)
- Manufacturing Controls
- Failure Investigations
- Cleaning Validation
- Manufacturing Process Validation
Level: A | Approx. Time: 45 min.
E-09. FDA Compliance and Enforcement Trends and Issues
- Warning Letter Statistics
- Critical GMP Deficiencies
- Recurring GMP Deficiencies
- Critical and Major GMP Compliance Issues
- FDA's Focus Areas
- FDA Foreign Inspection Compliance Statistics
- Recent GMP Interpretations (when available)
- New/Proposed Regulations and Guidance (when available)
Level: A | Approx. Time: 2 to 3 hrs.
*There is an additional fee of $1,000 for this module. Requests for this module should be confirmed at least one month prior to presentation to allow for updates and customization.
A-10. GMP for Executive Management
- GMP Objectives
- GMP Interpretations
- Current Compliance Issues and Trends
- Responsible Corporate Officer (RCO) Doctrine
- FDA Expectations for Executive Management
- Management Responsibilities
- Management Support for Compliance
Level: A | Approx. Time: 2 hrs..
*There is an additional fee of $1,000 for this module.
A-06. GMP Requirements and Compliance Issues for Clinical Supplies
- FDA Inspection Policy
- GMP Applications to Clinical Supplies
- GMP Interpretations for Clinical Supplies
- Change Control and Reporting
- Bio-Sample Retention Requirements
- FDA Pre-approval Inspection (PAI) Focus
Level: A | Approx. Time: 90 min.
A-11. Development and Technology Transfer Reports
- GMP Application
- FDA Recommendations
- Preparation and Contents of Development and Technology Transfer Reports
Level: A | Approx. Time: 75 min.
A-19. Good Documentation Practice and Compliance Review for Research and Development
- GMP Application
- Development and Technology Transfer Supports
- Good Research and Development Documentation Practices
- Good Science Systems and Practices
- Laboratory Reference Standard Controls
- Research and Development Support for FDA Pre-approval Inspection (PAI)
Level: A | Approx. Time: 90 min.
A-23. Electronic Records and Electronic Signatures - March 20, 1997
- Comprehensive review of the regulations and interpretations for each subpart
- Includes module A-28
Level: A | Approx. Time: 3 hrs.
A-28. Part 11 Guidance - Electronic Records and Signatures
- Review of Part 11 Guidance, August 2003
- FDA Enforcement Discretions for Selected Areas
Level: A | Approx. Time: 30 min.
E-07. Preparation for and Handling FDA Inspections
- Establishment of Company Policy and Procedures
- Logistics and Document Organization
- Personnel Training
- FDA Escort Team Qualifications
- Escort's Handling of Inspection and Responsibilities
- Discussion with Management (Exit Interview)
- Post Inspection FDA-483 Response
Level: A | Approx. Time: 75 min.
E-08. FDA Inspections: DOs and DON'Ts
- Basic Inspection Behaviors
- Answering FDA Questions
- Presenting Records to the FDA Investigator
- Inspection Participation Recommendations
Level: B | Approx. Time: 60 min.
E-10. Preparation for an FDA Pre-Approval Inspection (PAI)
- GMP Application
- Development and Technology Transfer Supports
- Good Research and Development Documentation Practices
- Good Science Systems and Practices
- Laboratory Reference Standard Controls
- Research and Development Support for FDA Pre-approval Inspection (PAI)
Level: A | Approx. Time: 60 min.