Spreadsheet Validation 2015 - Webinar CD/Transcript

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Spreadsheet Validation 2015: New Tools and Techniques to Meet FDA Requirements

Do your Microsoft Excel spreadsheets pass FDA muster? Can you assure they are validated, and meet strict 21 CFR Part 11 standards?

Do you know what needs validation and where to focus your efforts?  Do changes to Excel within Office 2013, Office 365 and cloud based applications affect your validation approach?

Would you like to learn a defined approach that can make your tasks simple and straightforward saving you both time and money?

Order the 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 you could perch on the shoulder of an expert on spreadsheet validation ... look on in real time as he highlights potential pitfalls and defines innovative validation approaches ... 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.

Spreadsheet validation expert David Harrison conducts a crash course in bulletproofing your Microsoft Excel spreadsheets.

The FDA advises that spreadsheets used for regulatory purposes should be validated and formal documentation maintained. Training is critical for everyone. 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 with respect to 21 CFR 210-211, 21 CFR Part 11 and 21 CFR Part 820 
  • Spreadsheet validation "gaps" the FDA is targeting
  • How to choose an approach for efficient and repeatable validation which fits into your traditional QA and validation processes
  • How to generate spreadsheet specifications and qualification protocols
  • 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 tools that improve security and audit trail capabilities and help streamline the validation process... you’ll also see examples of documentation contents and test scripts used during validation.

And don’t forget about updates on the latest validation and compliance trends towards cloud usage through Excel 2013 or Office 365.

Spreadsheet validation can close the compliance gap before you face high-profile FDA warnings and high-stakes liabilities.

The need spans all departments, including QA/QC, production, engineering — even finance. Must-attend job titles include:

  • Auditors
  • QA/QC specialists
  • Clinical research directors/managers
  • Compliance officers
  • Data management and statistics personnel
  • Financial accountants and auditors (SOX404)
  • Pharmaceutical and cGMP auditors
  • R&D staff
  • Study monitors/coordinators
  • Validation specialists, scientists and engineers
  • PLUS every compliance professional who uses Microsoft Excel spreadsheets

David Harrison is a principal consultant with CSV Compliance Limited and specializes in pharmaceutical/medtech compliance and computer system validation. David has managed the introduction and implementation of 21 CFR Part 11 and computerized system validation projects for many key blue-chip clients — including more than 250 spreadsheet validation projects. Mr. Harrison has worked within various quality assurance and consultancy roles within the drug, biotech and device industries. Previously David was responsible for spreadsheet validation and computer system validation for ABB Consulting.