CORPORATE TRAINING
CORPORATE TRAINING
Zetalix offers corporate training services in the areas of clinical research for the Pharmaceutical, Clinical Research, IT and Biotechnology sectors.
The main objective of our corporate training program is to impart knowledge based on the changing environment in the pharmaceutical, clinical research and biotechnology industries.
We offer customized onsite training programs in the areas of Basic and Advanced Good Clinical Practice/ GLP/Clinical Monitoring/ Pharmacokinetics/IRB Training/ Validation/ 21 CFR Part 11 etc.
Our Good Clinical Practice training package includes an introduction to Good Clinical Practice, targeted training, and focused risk-based learning. Learners get a basic knowledge of the topic, learning about the history of Good Clinical Practice, the Declaration of Helsinki, Good Clinical Practice principles, and the basics of roles and responsibilities. Good Clinical Practice training programs covers.
- Principles of ICH GCP
- History and purpose of GCP
- Roles and responsibilities of clinical research staff
- Ethics committees
- Essential documentation
- GCP sponsor responsibilities
- ICH GCP requirements and their impact on the role of the sponsor
- Awareness of the proper procedures, systems, and regulatory requirements in clinical research
- GCP for investigators
- ICH GCP requirements and their impact on the role of the investigators
- Strategies for ensuring adherence to the protocol
- Communication with the ethics committee
- Informed consent
- Drug accountability
- Safety reports