Spreadsheet Validation 2016 - Webinar CD/Transcript

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Spreadsheet Validation 2016: Tools and Techniques to Meet FDA Requirements

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.

Join trusted spreadsheet validation expert, David Harrison for a 90-minute presentation where he’ll discuss 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

Spreadsheet Validation is one of our most highly rated presentations. Here’s what some attendees 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 an expert.”
     - Barry Bowyer, Lenstec, Inc.

Order today and close the compliance gap before you face FDA warnings and liabilities.

  • 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. He 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.