Webinar from GlobalCompliancePanel on “Excel Spreadsheet Validation to Eliminate 483s”

David Nettleton, an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation, will be the Speaker at a webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize on June 17. The topic of this session is “Excel Spreadsheet Validation to Eliminate 483s”. Description: This session is about configuring and validating a GxP compliant spreadsheet application. Configuring and validating a GxP compliant spreadsheet application can be drab when learnt theoretically, but can be fun when learnt practically. The second of these options is what this highly interactive webinar will provide. This session will have complete and clear detail of this spreadsheet application. It will offer a live demonstration of the same. This will be followed by a collaborative workshop that explains the “how to” of the process threadbare. In combining step-by-step instructions with hands-on workings of each participant; this session is going to be truly unique. In order to derive the best benefit out of this session; participants are required to bring their laptop and use Excel for their own needs. As a result of this learning session, participants are sure to become more polished Excel users, on account of which they can save enormous amounts of time and costs. Areas Covered in the Session: o Develop spreadsheet applications that are GxP compliant. o Avoid 483s and warning letters. o What does and does not need to be validated. o Learn how to use Excel’s built in 21 CFR Part 11 features. o Apply features required for GxP environments without programming macros. o Validate your application with minimal documentation. o Follow along as we configure Excel for audit trails, security features, data verification, and multiple concurrent users. ----------------------------------------------------------------------------------------------------------------- When: June 17, 10:00 AM PDT | 01:00 PM EDT ----------------------------------------------------------------------------------------------------------------- By whom: Founder of Computer System Validation (CSV), David Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA and Computer System Validation. His latest book, Risk Based Software Validation –Ten easy Steps, relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 185 mission critical software validation projects. These have included clinical trial, blood bank, medical devices, document control, corrective action, laboratory instruments, electronic data capture, laboratory information management systems and so on. An accomplished author, David has written extensively on a range of Compliance issues. He is co-author of Commercial Off-the-Shelf (COTS) Software Validation for 21 CFR Part 11 Compliance (Davis Horwood International and PDA - www.pda.org), and Electronic Record Keeping; Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164 (Interpharm/CRC - www.crcpress.com). ----------------------------------------------------------------------------------------------------------------- For whom: The webinar will benefit o All Excel users o IT o QA o QC o Laboratory staff o Managers o Executives ---------------------------------------------------------------------------------------------------------------- Duration: 75 minutes ----------------------------------------------------------------------------------------------------------------- To enroll for this webinar, contact This email address is being protected from spambots. You need JavaScript enabled to view it. Ph: 800-447-9407 Fax: 302-288-6884

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