It is a well-known fact that when it comes to extremely specialized sectors like clinical research, gaining the necessary set of skills and industry know-how is really important. Effective training programs and online learning have a tremendous impact on practitioners’ approaches to various tasks and research projects. That’s why at Astra Nova we deliver industry recognized online courses, in-house training programs and webinars. Some of them include Good Clinical Practice, Good Distribution Practice, Good Laboratory Practice, Good Manufacturing Practice, Clinical Trials Risk Management, Computer System Validation, Clinical Data Management, Clinical Audits Training and many others.
Our comprehensive training agendas are updated with the latest information and releases. The case studies, training content and practical tests are well-structured and presented in an easy to comprehend way. They help research professionals, medical students, warehouse and distribution workers, regulatory bodies, compliance personnel and other people involved to stay up to date with guidelines, amendments to regulations, addendums and any other changes issued by authorities.
GCP, GMP AND GDP – INDUSTRY LEADINGS COURSES WHICH OUR CLIENTS PRIORITIZE ON
For the last couple of months, we notice an increasing interest in our Good Clinical Practice, Good Manufacturing Practice and Good Distribution Practice. After all, they are the most essential topics in the field of clinical research.
Back in November, 2016, ICH released an addendum to the GCP original guidelines. The revised document underlined the importance of using advanced approaches to the clinical trial design, conduct, oversight, recording and reporting, without endangering patients or posing any risks on human rights and safety. In this regard, our experts updated the content of our GCP course, ensuring that the revised agenda covers the amendments released in November. Apart from including all the explanations and terms which have been changed by the ICH last year (such as Certified Copy; Monitoring Plan; Validation of Computerized Systems), the online training also explains the following matters:
- revised principles of GCP
- updated investigators responsibilities
- integration of effective quality management system
- identification of data and critical processes
- identification, evaluation, reviewing and reporting of risks
- role of CROs
- data handling, reports and record keeping, using computerized systems
- monitoring processes
- all documents important for the correct organization and performance of clinical studies
For instance, one of the new aspects which has the goal to improve the effectiveness of monitoring procedures is the opportunity of sponsors to choose between on-site monitoring, centralized monitoring, a combination of centralized and on-site monitoring.
The GMP course also undergone significant updates and changes after the release of several new chapters in the official guidelines and the introduction of three upgraded Annexes.
Our training now highlights the changes to Annex 15: Qualification and Validation. The new version takes into account sections of the EudraLex, Volume 4, Part I, relationship to Part II, Annex 11, ICH Q8, Q9, Q10 and Q11, QWP guidance on process validation, and changes in manufacturing technology.
We have also provided explanations, clarifications and detailed information about several new chapters. Some of them are: “Transport Verification”, “Packaging Validation”, “Qualification of Utilities”, “Validation of Analytical Methods”, “Requalification” etc.
The European Commision published a new version of Anex 16 which focuses on Certification by Qualified Person and Batch Release. Therefore, we updated our course, reflecting the changes. Apart from redesigning and restructuring it, we updated the content of the GMP course so that it now allows practitioners to understand the most recent legislative requirements quickly and conveniently. In a separate section, we explain the purpose of controlling batch release; the requirements for certification by a Qualified Person (QP); the process of certification itself; general principles and revised responsibilities of the Qualified Person.
Lastly, since Anex 17: Real Time Release Testing was also revised, we made sure to incorporate the latest guidelines into the content of our online Good Manufacturing Course. We have included dedicated sections which explain what control strategy is and the importance of implementing one; risk assessment as part of real time testing; key parts of the RTRT plan; Parametric Release; Sterilisation Process and qualification on it in order to ensure that the sterilisation system design fits the process.
In conclusion, choosing the right course and acquiring in-demand skills has a significant role in the career development of researchers, nurses, regulators, CROs, monitors, distributors and other experts or newcomers involved in clinical trials. At Astra Nova, we aim to deliver the most comprehensive courses, designed in a way that complements their content and agenda.
If you are interested in purchasing any of our online training programs, you can do it by visiting the page bellow.