Conducting Value Added Audits of Technical Service Providers
This presentation will address conducting value added audits of
technical service providers (TSPs) providing services for and/or in
support of clinical trials and programs. TSPs would include those
vendors that provide technology-based services to pharmaceutical,
biotechnology, and medical device companies. These companies
would include, but are not limited to Electronic Data Capture (EDC),
Interactive Voice/Web Response (IVR/IWR), central
electrocardiograph (ECG) reading, electronic Patient Reported
Outcomes (ePRO), central imaging reading centers, etc. The
presentation will cover the following subject matters: why we
conduct audits of TSPs; the types of audits conducted of TSPs; the
process of conducting value added audits (before, during, and
after); and reporting processes.
Areas Covered in the Session:
l What is a Technical Service Provider?
l Definitions and terms
l Why Conduct Audits of TSPs?
l Types of Audits (presentation to focus on qualification and in-
l Pre-audit Activities
l On-site Activities
l Post-audit Activities
l Audit Close-out
l What's Next?
Click here to register for this webinar
Who Will Benefit: All personnel involved in processes of selecting,
qualifying, auditing, and creating contracts with technical service
providers. Including but not limited to: QA; clinical program and
project managers; and contract personnel.
Tuesday, August 31, 2010
10:00 AM PDT | 01:00 PM EDT
Mr. Dailey is current serving as the
Executive Vice President of Quality
Assurance Systems, Inc. (QAS), a
GXP consulting and professional
research services firm based in
Bonsall, CA, USA. QAS service areas
include Quality Systems
Development, Quality Assurance,
Inspection Readiness Assessments,
training, retrospective data review &
collection and expert testimony.