General Drug or Pharmaceutical cGMP and Quality Systems
About This eLearning
This digital learning program utilizes real-world scenarios, learner interactions, coordinated audio/video content, and engaging knowledge checks throughout each course to ensure student engagement. This course is presented in three modules, for approximately five hours of content.
Module 1: Introductory
This module provides the history of Good Manufacturing Practices (GMPs) and Basic Food and Drug Law to include discussion about USP, NF, Code of Federal Regulations, the FDA and the FD&C act. This section also outlines basic concepts of pharmaceutical quality systems and GMPs, explaining basic principles of a quality management systems in relationship to the commercial product lifecycle. In this section, students will also learn the importance of quality integration and basic concepts of GxPs and QMS principles, and the seven principles in pharmaceutical manufacturing throughout the lifecycle of each product.
Module 2: Intermediate
This section includes instruction on quality culture, quality systems, data integrity, documentation and records, procedures and GMP, fundamentals of GDP requirements, materials management controls, change management, change control and continuous improvement.
After completing this module, you will understand:
- Who is responsible for the quality culture
- How quality systems interrelate with the product lifecycle and how ICH Q10 relates to GxPs
- The importance of training and assessing your workforce
- The extent of data integrity implications
- The link between good documentation and recordkeeping
- Key elements of procedures and GMP
- Fundamentals of Good Distribution Practice requirements and controls
- The importance of a solid change management system and continuous improvement
- Change control and the differences between unplanned and planned changes
- How to focus on continuous improvement
Module 3: Advanced Topics
This section includes instruction on quality risk management, success metrics, GMP, audits and self-inspection, batch release systems, deviation and human error, complaints, quality defects and recalls.
After completing this module, you will be able to:
- Explain risk management and the importance of self-inspections
- Review the batch release system and be confident the QMS is under control
- Know the importance of deviation and human error
- Explain complaints, quality defects and recalls
- Measure the success of Good Manufacturing Practices