cGMP and VALIDATION TRAINING

The cGMP 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 4 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

This module uses a PowerPoint Presentation and includes the following:

Goal: Develop an understanding of the cGMP’s..

• 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 1/12 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.