What if you 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 you could discover the tips and tricks that will help you streamline your spreadsheet validation process for quick-and-final FDA approval?
Well, you can.
Mark your calendar for Tuesday, Dec. 11, 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 revalidated and a permanent record of all cell formulas be updated. Training is critical. Plan to sign up your entire team — you won’t want anyone to 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 choose an approach for efficient and repeatable validation
• How to fit spreadsheet validation into your traditional QA
and validation processes
• How to generate 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, you’ll 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, Harrison will walk you through his own spreadsheet to demonstrate what functionality needs to be validated and what security controls need to be put into place.
Like every FDAnews webinar, Spreadsheet Validation is convenient to attend. All that’s required is that you be in front of a screen at the appointed time, whether you’re at the office or telecommuting from your home office.
Harrison will be on hand to answer all of your questions. Simply submit your questions via email, and you’ll have answers by the time the session ends.
Everyone in your organization with a role in spreadsheet validation deserves to take part in this event — and they can do so at a cost that won’t break the budget. You pay one single low registration fee per facility, regardless of how many participate.
Who Will Benefit
The need spans all departments, including QA/QC, production, engineering — even finance. Must-attend job titles include:
• Clinical QA/QC specialists
• Clinical research associates
• Compliance officers
• Data management and statistics personnel
• Financial accountants and auditors (SOX404)
• 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
Tuesday, Dec. 11, 2012
Your laptop, office or conference room (No need to travel!)
11:00 a.m. – 12:30 p.m. EST
10:00 a.m. – 11:30 a.m. CST
9:00 a.m. – 10:30 a.m. MST
8:00 a.m. – 9:30 a.m. PST
4:00 p.m. – 5:30 p.m. GMT
Price: Webinar Plus Audio CD and Transcript: $527
You’ll have access to one log-in and dial-in for the live 90-minute webinar for unlimited participants. You also receive all presentation materials and the opportunity to ask questions by phone and email, plus an audio CD and transcript for the entire session.
Webinar Only: $327
You get one log-in and dial-in for the live 90-minute webinar for unlimited participants, presentation materials and the opportunity to ask questions by phone and email.