Webinar on Validation and Use of Excel Spreadsheets in FDA Regulated Environments

Description :

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 Covered in the Session :

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:

Compliance Officers

Regulatory Affairs Personnel

Clinical Affairs Personnel

Quality Assurance Personnel

Laboratory Personnel

IT Professionals

R&D Professionals

Consultants

Contractors/Subcontractors

Any professionals interested in this topic

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1689