FDAnews Announces — Spreadsheet Validation 2015: New Tools and Techniques to Meet FDA Requirements Webinar, June 25, 2015

Share Article

What if drug and devicemakers 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? Sign up now for a hands-on learning experience led by trusted spreadsheet validation expert David Harrison.

Spreadsheet Validation 2015:
New Tools and Techniques to Meet FDA Requirements
**FDAnews Webinar**
June 25, 2015 — 11:00 a.m. – 12:30 p.m. EDT
http://www.fdanews.com/SpreadsheetValidation

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

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

What if drug and devicemakers 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 manufacturers could discover the tips and tricks that will help them streamline their spreadsheet validation process for quick-and-final FDA approval?

Mark the calendar for Thursday, June 25, when spreadsheet validation expert David Harrison conducts a crash course in bulletproofing Microsoft Excel spreadsheets.

The FDA advises that spreadsheets used for regulatory purposes should be validated and formal documentation maintained. Training is critical for everyone. Attendees will learn 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 the 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, attendees will learn about third-party software tools that improve security and audit trail capabilities and help streamline the validation process.

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 manufacturers face high-profile FDA warnings and high-stakes liabilities.

Who Will Benefit:

  •     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

Meet the Instructor:
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.

Conference Details:
Spreadsheet Validation 2015:
New Tools and Techniques to Meet FDA Requirements
**FDAnews Webinar**
June 25, 2015 — 11:00 a.m. – 12:30 p.m. EDT
http://www.fdanews.com/SpreadsheetValidation

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/SpreadsheetValidation
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.

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Michelle Butler
FDANEWS
+1 (703) 538-7665
Email >
FDAnews
Like >
Visit website