Training Modules

Select a training module below to learn more or contact us to book GMP training. If a topic of interest is not included in the program listing, we may be able to develop a customized program to meet your needs.

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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-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.

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