Implementing a Quality Systems-Based Approach to GCP Compliance
Overview:
Ensuring GCP quality has often been approached from the perspective of reviewing as many documents as possible, looking for errors and following up on corrections or making "notes to file." In order to design, implement, and maintain GCP compliance in an effective manner, a Quality Systems Approach should be adopted.
In the GMP and GLP domains, this approach has led to more effective and efficient maintenance of compliance, since only by implementing effective systems can quality and compliance be established, monitored, and then maintained. Your speaker will describe the GMP Quality System, and how, in a similar manner, a GCP Quality System can be utilized by ensuring the proper establishment of investigator oversight and documentation; IRB oversight; sponsor monitoring; corrective and preventive action (CAPA) execution; IP controls; Clinical Staff and lab qualification. Your speaker will discuss each sub system in detail, why it exists, and how working together, they protect patient safety, rights, and welfare. Your speaker will present proposals for adopting this approach at clinical sites, as well as the role of the sponsor in establishing internal GCP quality systems, and ensuring compliance at the sites and CROs. The topic of auditing from a Quality Systems-Based Approach will also be discussed. Your speaker will also address why it is difficult to get clinical sites to use a "systems" approach and will give real-life examples of failures to deploy and implement these systems properly based on recent warning letters from FDA.
Why Should You Attend: In this webinar you will learn to see GCP compliance as an interaction of several sub-systems the work together to ensure patient safety and ethical treatment.
Areas Covered in the Seminar:
- Background for Clinical Trials and GCP (Good Clinical Practice)
- The benefits of a Quality System approach
- GCP Quality System
- The Importance of the sub-systems: PI Oversight and Record Keeping; IRB Oversight; Monitoring; Clinical Staff and 3rd Party Qualification; IP Handling; Pharmacovigilance/Patient Safety
- GCP Compliance Audits
- Ranking the Severity of Observations
- Resolutions of Deviations
- References
Who Will Benefit:
- Auditors
- Study Coordinators
- Managers
- Directors
- Principle Investigators