This self-paced learning course provides comprehensive instruction on the general drug or Pharmaceutical cGMP and Quality Systems requirements. This course utilizes real-world scenarios to instruct on the practical application of these requirements, embedded video and audio content, engaging knowledge checks throughout each module, and a final competency assessment.
The program is presented in three modules: - approximate course completion time = *5 hours
1. Introductory Topics – approximately 1 hour
Provides the history of 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.
2. Intermediate Topics – approximately 2.5 hours
This section includes instruction on: Quality Culture, Quality Systems, People, Data Integrity, Documentation and Records, Elements of Procedure and GMP, Fundamental of GDP Requirements, Materials Management Controls, Change Management, Change Control and Continuous Improvement.
3. Advanced Topics – approximately 1.5 hours
This section includes instruction on: Quality Risk Management, Measuring Success: GMP, Audits and Self Inspection, Batch Release System, Deviation and Human Error, Complaints, Quality Defects and Recalls.
*Time is approximate and based on the amount of content included in each section. Content is self-paced, driven by the learner.
By completing/passing this course, you will attain the certificate Pharma Certificate
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