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2005 WORKSHOPS: Essential SOPs and Documentation for CDM
Location: Georgetown University Marriott Conference Center, Washington DC
Date: 12 & 13 April 2005
The Regulatory Compliance Workshop Group are delighted to announce the 2nd Annual Workshop event on 'Essential SOPs and Documentation for CDM'. This event will take attendees step-by-step through what is expected by the regulators and how to generate compliant documents that meet both regulatory and organizational requirements.
The event will include 4 workshops - (1) Creating SOPs for Data Management to Meet Regulatory Requirements, (2) Data Management Plan VS. Data Management SOPs Binder, (3) Quality and Control, (4) Documentation and Validation - Ensuring Compliance and Dealing with Non-compliance. Other topics to be addressed include: Regulatory requirements and guidelines governing SOPs for CDM; Essential Good Clinical Data Management Practices; Critical Components of SOPs; Data Management Standards and SOPs; Documenting Data Management Activities; Validation and SOPs; Revision of SOPs; Training Strategies; What happens when SOPs are non compliant?; SOPs for large VS. small organizations; Locking databases and SOPs; How to work with an outsourced vendor.
For further information please go to our website:
http://www.rcwg.org
Or contact our Registration Manager (Sharon Thomas) at:
Tel: 301.552.8741
Fax: 301.552.9536
Email: RCWG[at]Comcast.net
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Submitted by
Nobody
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posted on
Tuesday, March 8, 2005
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Let me introduce my self. I am administer of bioinformatics lab. We
have planned to make a high-tech Bioinformatics lab. I need some help
regarding what should be present in such lab like computing hardware
and other things like that.
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