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 The on-demand bundled course series includes the following modules: 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 relationship 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 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 •    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. Read More

This session is ideal for engineering technicians as well as contract and technical support staff who need to be aware of how their actions may create or contribute to GMP non-compliances, which may affect product quality. Exercises and case studies help you recognise how much interaction you have with GMP-compliant processes/systems, how to mitigate risks associated with each interaction with validated/qualified systems and your key role in maintaining compliant processes within the bigger team. A certificate will be issued upon successful completion of a short end of session assessment.  Read More

The purpose of this course is to provide an overview of current Good Distribution Practices (GDP) and the fundamental requirements for a wholesale distribution authorisation holder and why GDP is so important in the provision of safe, efficacious medicines to our patients. Read More

This training course covers the GxP Inspection Management Lifecycle.  It is suitable for staff wanting to understand more about GCP, PV, GMP and GDP regulatory inspections from planning, conduct and responding to inspection findings.  Read More

This eLearning provides an overview of ICH Q8 Pharmaceutical Development, ICH Q9 Quality Risk Management (QRM) and ICH Q10 Pharmaceutical Quality System (PQS).  It summarises the key principles and benefits that accrue with the effective and collective implementation of ICH Q8,9 and 10. Each section concludes with a short quiz to test your knowledge and following successful completion of the course, you will be issued with a certificate. Read More

An interactive session on Human Error Prevention and the best practices from industry.  Compare your company against the best in class and learn how to improve your error rate.  Read More

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