Course Overview
Course focuses on GCPs, and FDA/ICH regulations required by Sponsors, CROs, and compliance towards pharmaco-vigilance. It also deals with issues in clinical regulatory submissions and what inspectors are looking behind contractual and corporate arrangements and PI financial disclosures.
Prerequisite(s)
- No prerequisites are required for this course.
Credits
0.0
- Retired
- This course has been retired and is no longer offered. Find other Flexible Learning courses that may interest you.
Learning Outcomes
Upon successful completion of this course, the student will be able to:
- Apply clinical research (FDA, EU & Health Canada) regulations for biopharmaceuticals and medical devices.
- Identify the main audit cycle stages and inspection process.
- Outline the necessary techniques to plan, organize and conduct audits and inspections.
- Prepare for the inspections conducted regulatory agencies for GCP compliance
- Apply the methodology needed for writing effective audit/inspection reports.
- Utilize the systems required for following up on Corrective Actions resulted from Audits/inspections.
Effective as of Fall 2009
Programs and courses are subject to change without notice. Find out more about BCIT course cancellations.