This Laboratory Investigation training will provide guidance on procedures investigating unexpected results for Non-Clinical and Clinical Trials and will discuss several suggested procedures, avoiding unnecessary re-analysis.
Areas Covered in the seminar :
- FDA restriction and guidance covering sample re-analysis.
- Establishment of complaint handling program.
- What constitutes valid re-analysis.
- CRM/CRA/Medical Officer Requests for re-analysis.
- Pre-analytical errors and investigations.
- Analytical errors and investigations.
- Post analytical errors and investigations.
Who will benefit :
This webinar will provide valuable assistance to all regulated companies, since sample re-analysis issues will arise across the Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
- Regulatory management
- QA management
- Clinical Research Managers and Associates
- Sales personnel
- Quality system auditors