To achieve and remain compliant with the adequate use of the Excel spreadsheet in FDA-regulated environments, it is critical that laboratory personnel and managers including IT professionals understand and accurately interpret the applicable requirements. This is necessary to ensure compliance to Excel spreadsheets is sustainably demonstrated and achieved.
This webinar will discuss the adequate application (use) of Excel spreadsheets, which are frequently used in FDA regulated environments. You will understand how to use Excel spreadsheets, if and when required, in compliance with the list of requirements for the firm’s practices under 21 CFR Good Laboratory Practice (GLP), Good Clinical Practice, Good Manufacturing Practices (21 CFR Parts 210, 211, 820), 21 CFR Part 11 (Electronic Records), etc.
You will gain awareness of the following citations in FDA’s enforcement actions (e.g., FDA warning letters) including 483s which firms should be aware of.
The Excel spreadsheets – neither controlled nor protected from modifications or deletion.
An Excel spreadsheet has not been qualified.
Excel spreadsheets are Non-qualified and uncontrolled.
The use of an Excel spreadsheet was not validated by your firm.
This session will provide you with great opportunities as quality and regulatory managers to become actionably familiar with the regulatory requirements applicable to Excel spreadsheets.
Areas to be Covered:
Applicable Regulations and Definitions
Applicable Regulations for Medical Devices
21 CFR Part 11
FDA Guidance: Relevant and Applicable
Common Problems in 483s related to Excel Spreadsheets
Leading Causes of Common Problems in Excel Spreadsheets
Regulatory Requirements Applicable to the Excel Spreadsheet
Use of Excel Spreadsheets in FDA-Regulated Environment: Common Problems
What to Do for Excel?
Excel Validation – Documentation
FDA Checklist for Excel Document for Consideration
FDA Warning Letters
Excel Data Validation
Excel Data Validation: Input Message/ Error Alert
Excel Functions for Protection
Protecting the Worksheet
Be Aware of Excel’s Limited Functions
Best Practices: Dos and Don’ts
Speaker’s Recommendation and Suggestions on PASS-IT Solutions
Who will Benefit:
Regulatory Affairs Personnel
Clinical Affairs Personnel
Quality Assurance Personnel
Any professionals interested in this topic