Description
Health Canada has been performing routine surveillance inspections of clinical trial sites and sponsors since 2001. This presentation describes the content and interpretation of the currently available Health Canada guidance documents, policies, and reports. This information is used to create training aids and compliance checklists to help clinical site, vendor, and sponsor personnel understand the expectations of Health Canada inspectors, and prepare their sites and facilities for future regulatory inspections.
- Describe the key information in Health Canada guidance documents, policies, and reports, and the relationship to clinical inspection findings.
- Differentiate between critical and non-critical inspection findings.
- Develop compliance checklists for training and self-assessment audits, in preparation for regulatory inspections
Speaker(s):
- Patricia
Jones,
ART, RAC,
Director, Quality and Regulatory Compliance,
Therapeutic Products, Inc. (TPIreg)
