Applying Quality Systems Concepts to Clinical Research Activities

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

Instructor Profile:

Glenda Guest , is Vice President of Norwich Clinical Research Associates Ltd. (NCRA), a full service Clinical Contract Research Organization (CRO) serving the pharmaceutical, medical device, biologics and nutritional product industries since 1994. She specializes in medical device monitoring and project management, auditing and training on US regulated research, quality systems and Good Clinical Practices in clinical research settings as well as for professional organizations.

Her auditing experience includes GCP auditing, independent third party, pre-PMA audits, Japanese GCP preparation audits and includes corrective action recommendations. She provides SOP development assistance and staff training relative to correcting audit deficiencies.

Ms. Guest has maintained her status as a Registered Quality Assurance Auditor - Good Clinical Practices (RQAP-GCP) through the Society of Quality Assurance since 1997. She is a published writer, trainer and invited speaker at local and global professional meetings.

Topic Background:

Regulatory agencies are sending a strong message that they expect to see quality systems built into clinical research activities. Sponsors and research sites continue to struggle to identify how the key concepts from the US FDA Quality System Regulation (QSR - 21 CFR Part 820) are applicable in the clinical arena.

One component of a strong quality system is vendor management and oversight. You already manage your other vendors, such as those who supply you with materials to manufacture your product. Since the validity and reliability of the data provided by clinical research sites is crucial for the regulatory approval of your product, you need to learn how to apply vendor management concepts to management of clinical research activities.