This Clinical Trial Auditing webinar will help you in preparing your site for a GCP audit. Attendees will learn how to identify and remedy gaps in their monitoring system and prepare for regulatory inspections.
It will be important to see what the FDA regulations and the ICH GCP recommendations are in this regard. The key is that the PI and all clinical staff know and follow the research plan (Protocol) exactly as it is written. To do this is ethical research. To not follow the protocol and document study conduct carelessly is folly.
Areas Covered in the Seminar:
- The Sponsor‘s responsibility in monitoring study conduct.
- Components of a sponsor monitoring system beyond SOPs.
- The nature of adequate oversight of all staff and non-staff.
- The importance of Protocol knowledge in preventing errors.
- How do sites prepare for an audit / inspection.
- The measures to ensure quality monitoring.
- The gaps monitoring systems.
Who Will Benefit:
This Webinar will provide invaluable assistance to all personnel in the Pharmaceutical, Biotechnology, and CRO industry conducting Clinical Trials including:
- Sponsor Senior Management,
- Project Managers,
- CRA Managers,
- QA/Compliance persons
In CRO's and sites, those benefiting the most would be:
- Principal Investigators and sub investigators
- Clinical Research Scientists (PKs, Biostatisticians, ...)
- Safety Nurses
- Clinical Research Associates (CRAs) and Coordinators (CRCs)
- Recruiting staff
- QA / QC auditors and staff.
- Clinical Research Data managers
Note: Use this promocode(117660) for 10% discount.