This 30 minute self-paced learning course provides an overview of the requirements of a deviation investigation and CAPA process. It defines the key features of the system, as well as the lifecycle of the deviation investigation steps: Defining the problem, Conducting a risk assessment, Collecting and analysing data, Conducting root cause analysis, Developing and implementing CAPA’s, Final impact assessment/Deviation closure and Conducting effectiveness checks. Read more

This course provides comprehensive instruction on the EU IVDR. It covers all aspects of the regulation and identifies key topics and changes, including the economic operators and new roles associated with EU IVDR, standard requirements that must be met by all IVD manufacturers, and pre- and post-market requirements of conformity assessment.​ Read more

This course provides comprehensive instruction on the EU MDR. It covers every aspect of the regulation and identifies key topics and changes, including economic operators and new roles associated with EU MDR, standard requirements that must be met by all manufacturers regardless of class, and the pre- and post-market requirements of conformity assessment. Read more

This course provides a greater understanding of the key requirements outlined in the EU MDR for medical device technical documentation. Learners will be able to conceptualize the regulatory requirements and the Notified Body expectation for technical documentation, helping to reduce unnecessary delays to the certification process. The content in this course supports the creation of compliant and Notified Body-friendly technical documentation. Read more

This online self-paced eLearning course provides comprehensive instruction on General Drug or Pharmaceutical cGMPs and Quality Systems. The program 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 one-hour self-paced eLearning course provides essential GMP refresher training required for all individuals involved in the manufacture and supply of medicinal products.  It provides a reminder of the different regulatory organisations globally that are responsible for defining Good Manufacturing Practice requirements, as well as a reminder of the Golden Rules of GMP.  It highlights the most frequent regulatory inspection findings against cGMP from both the FDA and MHRA, as well as providing an enhanced focus on data integrity.  It concludes with providing an overview of those evolving areas of GMP, such as CSV and the impact of digital solutions (AI and ML), regulatory focus on security of supply and the impact on the environment. This course includes a competency assessment that, with successful completion, leads to a certificate of completion.  Read more