CIS' Clinical Vendor Oversight Webinar to Address Key Areas that are Often Overlooked
Clinical subject matter experts at CIS will provide insight on the role of vendor oversight in a successful compliance program.
- Raleigh-Durham-Chapel Hill, NC (1888PressRelease) March 22, 2012 - Compliance Implementation Services (CIS), a leading life sciences consulting firm, today announced that it will host a Pharma Compliance Insight (PCI) webinar on Proactive Vendor Oversight on Thursday, March 22 from 2:00 to 3:15pm EST. CIS' subject matter experts will discuss the key elements of a quality management plan and provide instances of FDA warning letters that could have been avoided through proper oversight.
Quality oversight of clinical R&D vendors is becoming more complex and increasingly important. Common tools for clinical trial vendor oversight include carefully crafted quality agreements, risk evaluations of vendor SOPs, co-monitoring activities, vendor audits, and corrective/preventive action programs. Yet, industry experience shows that these tools are being underutilized and therefore do not allow a sponsor to ensure that vendors are complying with basic Good Clinical Practice (GCP) requirements that protect clinical trial subjects and maintain integrity of data in outsourced clinical trial activities. Establishing a formal vendor oversight program is a practical strategy for showing regulatory authorities that you have adequate oversight of outsourced activities and are protecting patient safety and data integrity.
CIS' clinical experts Billy Grimme and Kristin Williams will discuss the role of vendor oversight in a successful compliance program. Learn best practices and steps to ensure your program's progress, while avoiding miscommunications and unexpected events.
To register and submit questions in advance, visit http://cis-partners.com/resources/webinars.html. Email info ( @ ) cis-partners dot com for more information on how you can meet vendor oversight challenges and build or improve upon a comprehensive Quality Management System (QMS) dot
About Compliance Implementation Services (CIS) Compliance Implementation Services (CIS) is a leading life sciences consulting firm specializing in compliance strategies for pharmaceutical, biotech, and medical device companies, from clinical research and development, through manufacturing, commercial compliance, and Government Programs.
CIS provides its clients with a deep understanding of industry laws and regulations, innovative and practical applications, and custom solutions to guide them to a better "Culture of Compliance" that is meaningful and sustainable. For more information, visit www.cis-partners.com.
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