SMB Validation

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:

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:

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..

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:

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:

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:

This module lasts approximately 1 hour.