This webinar will help you identify key concepts from the US FDA Quality System Regulation (QSR - 21 CFR Part 820) that are applicable in the clinical arena, and show how you can build them into your clinical research activities.
Do you understand key concepts from the QSR?
What are Risk Management and Corrective and Preventive Actions (CAPA)?
What exactly is Vendor Management in this type of setting?
Do you know how to apply those concepts, originally developed for the manufacturing setting to a clinical research setting?
Recognizing the parallels between GMP vendor management and other Quality System requirements and GCP activities at research sites and applying these concepts contributes to an improved overall quality system.
This webinar is designed to help participants see the parallels between Quality System activities in the manufacturing setting and how they can be applied to clinical research. The protocol, investigator agreements, qualification visits and other activities already performed by the majority of individuals engaged in regulated research are related to manufacturing supplier contracts, vendor qualification audits and other vendor management activities. This perspective will help participants find creative ways to implement vendor management and quality systems activities at a clinical site level.
All functional groups who have clinical trial responsibilities or need to understand basic quality systems concepts for clinical research will benefit from this webinar.
Why Should You Attend:
Sponsors and research sites are striving to incorporate ‘quality systems’ into their clinical research activities.Do you understand key concepts from the QSR?
What are Risk Management and Corrective and Preventive Actions (CAPA)?
What exactly is Vendor Management in this type of setting?
Do you know how to apply those concepts, originally developed for the manufacturing setting to a clinical research setting?
Recognizing the parallels between GMP vendor management and other Quality System requirements and GCP activities at research sites and applying these concepts contributes to an improved overall quality system.
This webinar is designed to help participants see the parallels between Quality System activities in the manufacturing setting and how they can be applied to clinical research. The protocol, investigator agreements, qualification visits and other activities already performed by the majority of individuals engaged in regulated research are related to manufacturing supplier contracts, vendor qualification audits and other vendor management activities. This perspective will help participants find creative ways to implement vendor management and quality systems activities at a clinical site level.
All functional groups who have clinical trial responsibilities or need to understand basic quality systems concepts for clinical research will benefit from this webinar.
Areas Covered in the Seminar:
- Brief overview of Quality System Regulation in the US (21 CFR Part 820).
- Risk Management.
- Quality Control versus Quality Assurance.
- Vendor (Research Site) Qualification.
- Protocol Development Considerations.
- Training Documentation.
- Monitoring Activities.
- CAPA concepts.
Who Will Benefit:
- Clinical Research Managers
- Clinical Project Managers
- Clinical Research Associates/Monitors
- Site Administrators
- Clinical Research Coordinators
- Clinical Investigators
Course Provider
Glenda Guest,
