GMP and Validation Training
The GMP Training Program is designed specifically to teach the “language” of the industry and to develop within attendees a good understanding of the requirements and regulations that control the day-to-day activities of a GMP facility.
Module 1: Overview of Regulations and Validation and Documentation Concepts
Goal: Provide a basic understanding of the regulatory framework in place in the Pharmaceutical and Medical Device industry and introduce the participants to basic Validation and Documentation concepts.
This module uses a PowerPoint Presentation and includes the following:
- Objectives of Training Session
- Introduction and Qualifications of Trainer
- Historical review of the evolution of the regulations for Pharmaceutical and Medical Device Manufacturers
- Validation: Some Definitions and Requirements
- Current Validation Practices and Regulations
- Basic Concepts of Documentation Requirements
- Verification of Knowledge Acquisition
This module lasts approximately 3 hours.
Module 2: General cGMP and Equipment Design Topics
Goal: Develop an understanding of GMP design practices in use within the Pharmaceutical and Medical Device Industry.
This module is in the form of a Round Table discussion and includes the following:
- Objectives of Training Session
- GAMP Concepts
- 21 CFR Part 11 Requirements and Implications
- Clean Room and Aseptic Manufacturing Concepts
- General Considerations for Design and Construction of Equipment for the Pharmaceutical and Medical Device manufacturers
- Product Contact Parts Requirements and Practices
- Cleaning Validation Concepts
- Basic Calibration Concepts
- Product Yield and Label Reconciliation Requirements
- Verification of Knowledge Acquisition
This module lasts approximately 3 hours.
Module 3: cGMP Orientation
Goal: Develop an understanding of the cGMP’s.
This module uses a PowerPoint Presentation and includes the following:
- Objective of Training Session
- Definitions of selected terms used in the Pharmaceutical and Medical Device industry
- Who is responsible for compliance?
- Brief review of regulation history
- The need to document
- Drug Product Production Cycle
- Types of Quality
- Consequence of Non-Compliance
- Verification of Knowledge Acquisition
This module lasts approximately 1 1/2 hours.
Module 4: Standard Operating Procedures
Goal: Develop an understanding of procedural practices in use within the Pharmaceutical and Medical Device Industry.
This module uses a PowerPoint Presentation and includes the following:
- Objective of Training Session
- What is a Procedure?
- Goal of a Procedure
- When are Procedures used?
- What do Regulatory Agencies expect when looking at Procedures?
- The Notion of Promise with respect to Procedures
- Verification of Knowledge Acquisition
This module lasts approximately 1 hour.
Module 5: Record Keeping and Quality Assurance
Goal: Develop an understanding of Record Keeping practices in use within the Pharmaceutical and Medical Device Industry as well as an understanding for Quality Assurance/Control Procedures and Responsibilities.
This module uses a PowerPoint Presentation and includes the following:
- Objective of Training Session
- Selected Definitions
- Types of Records
- Procedures and Records - The Notion of Promise (Re-Visited)
- Testing Sequence within the Drug Production Cycle
- Who is responsible for quality?
- Verification of Knowledge Acquisition
This module lasts approximately 1 hour.
Module 6: Cost Considerations in Validation
Goal: Develop an awareness of the costs of validation and of the responsibilities of various parties within the Validation Process.
This module uses a PowerPoint Presentation and includes the following:
- Types of Costs
- The Role of the Pharmaceutical or Medical Device Manufacturer
- The Role of the Equipment Designer/Builder
- The Role of the Validation Provider
- Other Costs Considerations
- Verification of Knowledge Acquisition
This module lasts approximately 1 hour.
Contact us to learn more about our cost-effective, comprehensive GMP Training services.
