FDAnews Announces Spreadsheet Validation Webinar, Dec. 10
Falls Church, VA (PRWEB) November 19, 2013 -- Spreadsheet Validation
New Tools and Techniques to Meet FDA Requirements
**FDAnews Webinar**
Nov. 22, 2013 — 11:00 a.m. – 12:30 p.m. EST
http://www.fdanews.com/Excel2014
Do the Microsoft Excel spreadsheets pass FDA muster? Can they meet strict 21 CFR Part 11 standards?
Do drug- and devicemakers know the changes that will be made to Microsoft Excel in 2014 and how to validate them?
Sign up now for a hands-on learning experience led by a trusted spreadsheet validation expert. Training is critical for anyone in the drug or device industry who oversees or uses spreadsheets for data collection, data processing or data reporting.
What if spreadsheet users could perch on the shoulder of an expert on spreadsheet validation ... look on in real time as he posts entries and manipulates cells ... ask why he does this instead of that ... and get feedback?
What if users could discover the tips and tricks that will help them streamline their spreadsheet validation process for quick-and-final FDA approval?
Well, they can.
Mark the calendar for Tuesday, Dec. 10, when spreadsheet validation expert David Harrison conducts a crash course in bulletproofing your Microsoft Excel spreadsheets.
The FDA advises that all spreadsheets should periodically be re-validated and a permanent record of all cell formulas be updated. Training is critical for everyone. Don’t miss out on learning the best practices and available options for validating spreadsheets, including:
• Exactly what the FDA looks for and why, including examples of noncompliance and regulatory concerns
• Spreadsheet "gaps" the FDA is targeting
• How to address the FDA requirement that spreadsheets be validated per 21 CFR 210-211 and Part 820
• How to choose an approach for efficient and repeatable validation
• How to fit spreadsheet validation into your traditional QA and validation processes
• How to generate 2014 compliant spreadsheet specifications
• What to include in spreadsheet qualifications
• How to test spreadsheets and macros
• How to plan, manage and resource an effective project
• Sources of FDA publications on spreadsheet use and validation
Plus, attendees will learn about third-party software features that improve security and audit trail capabilities within Microsoft Excel spreadsheets ... and see examples of documentation contents and test scripts used during validation.
Step by step, Mr. Harrison will walk attendees through his own spreadsheet to demonstrate what functionality needs to be validated and what security controls need to be put into place.
Spreadsheet Validation is one of our most popular webinars. Prior years’ sessions drew hundreds of participants from across the country. Here’s what some said:
“I liked that the potential options for spreadsheet compliance were well explained and the additional information sources on spreadsheet validation were provided.”
- Marko Oblak, Lek Pharmaceuticals
“This was a concise presentation with quality information from experts.”
- Barry Bowyer, Lenstec, Inc.
Spreadsheet validation can close the compliance gap before you face high-profile FDA warnings and high-stakes liabilities.
Who Will Benefit
The need spans all departments, including QA/QC, production, engineering — even finance. Must-attend job titles include:
• Auditors
• Clinical QA/QC specialists
• Clinical research associates
• Compliance officers
• Data management and statistics personnel
• Financial accountants and auditors (SOX404)
• Managers
• Pharmaceutical and cGMP auditors
• QA/QC personnel
• R&D staff
• Study monitors
• Study research coordinators
• Validation specialists, scientists and engineers
• PLUS every compliance professional who uses Microsoft Excel spreadsheets
Meet the Instructor
David Harrison is a principal consultant with ABB Engineering Services who specializes in pharmaceutical compliance and validation. He is the product manager for the ABB Excel Validation Solution and is responsible for managing the company's product and support services worldwide. His previous roles at ABB were in the introduction and implementation of 21 CFR Part 11 and computerized system validation projects and initiatives for key blue-chip pharmaceutical clients. Prior to joining ABB, Mr. Harrison worked in various quality assurance roles within the drug and biotech industry in both the UK and the US.
Conference Details
Spreadsheet Validation
New Tools and Techniques to Meet FDA Requirements
**FDAnews Webinar**
Nov. 22, 2013 — 11:00 a.m. – 12:30 p.m. EST
http://www.fdanews.com/Excel2014
Tuition
$547 per site -- includes webinar registration and audio cds and transcripts
Easy Ways to Register
Online: http://www.fdanews.com/Excel2014
By phone: 888-838-5578 or 703-538-7600
About FDAnews
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
Michelle Butler, FDANEWS, http://www/fdanews.com/Excel2014, +1 (703) 538-7665, [email protected]
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