The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: February 25, 2014 from 10am to 10am
Location: Online Event
Street: 2600 E. Bayshore Road
City/Town: Palo Alto
Website or Map: http://www.complianceonline.c…
Event Type: clinical
Organized By: ComplianceOnline
Latest Activity: Feb 6, 2014
This webinar will cover regulatory requirements for archiving clinical trial documents, both paper and electronic records. It will focus on the key components of a digital preservation strategy to ensure the ongoing retrievability and accessibility of clinical trial electronic records.
Why Should You Attend:
If you do not know the answer to one or more of these questions attending this one-hour webinar will help you to be better informed requirements for archiving.
This session will be introduced with an overview of the regulations that pertain to archiving of trial documents, including getting clarification on some of the key terminology used. We will then explore specific aspects of establishing and managing archives and how we can effectively meet the expectations of regulatory agencies. Managing electronic documents introduces an additional level of complexity due to the potential obsolescence of hardware, software and operating systems and the natural degradation of electronic storage media. We will look at strategies for mitigating these issues.
At the end of this webinar, participants will understand what the regulatory requirements are for archives and archival processes and will be able to describe the key components of a digital preservation strategy to ensure the ongoing retrievability and accessibility of electronic records.
Areas Covered in the Webinar:
Who will Benefit:
This webinar will provide valuable assistance to the following personnel:
Eldin Rammell, is an independent records management consultant with over 25 years experience within the life sciences sector. Gaining experience within major pharmaceutical companies, he has managed on site and off site records centres and archives and overseen major records management projects. During the last 10 years, he has been the owner and principal consultant at Rammell Consuting Ltd, providing bespoke consultancy in clinical records management. He has been engaged as a consultant on several eTMF implementation projects for clients ranging from multinational pharmaceutical companies to small biotechnology companies. He is recognized as an industry key opinion leader in the area of TMF management and is a regular conference speaker.