Course description
General Drug or Pharmaceutical cGMPs and Quality Systems
This online self-paced eLearning course provides comprehensive instruction on General Drug or Pharmaceutical cGMPs and Quality Systems.
The programme is presented in three modules. Each Module is between 1 to 2.5 hours in duration. The course is approximately 6 hours total including a comprehensive exam at the end of each module. Students must receive 80% on the comprehensive exam. Upon successfully completing the exam, students will print individual course completion certificates to be included as evidence of competency in their training files.
Upcoming start dates
Outcome / Qualification etc.
Upon successfully completing the exam, students will print individual course completion certificates to be included as evidence of competency in their training files.
Training Course Content
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 System in relation to the commercial product lifecycle. 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
- 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
- Continuous Improvement
3. Advanced topics - approximately 1.5 hours
- 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.
Why choose NSF International, Health Sciences
Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course
Provided expert health sciences training for over 30 years
More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider
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Expenses
Discounts
Multiple participants and early bird booking discounts available. Discounts also offered to NHS staff, regulators and charities.