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Feb 07


EXCEL SPREADSHEETS: ENSURING DATA INTEGRITY AND 21 CFR PART 11 COMPLIANCE

This webinar will explain how to avoid FDA 483s by proper configuration and
validation of GxP compliant spreadsheet applications.

By The Comply Guide
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14 followers


WHEN AND WHERE


DATE AND TIME

Tue, February 7, 2023, 10:00 AM – 11:30 AM PST


LOCATION

Online


REFUND POLICY

Refunds up to 1 day before event


ABOUT THIS EVENT

 * 1 hour 30 minutes
 * Mobile eTicket

Course Description:

In this interactive webinar, our industry expert David Nettleton will explain
how to avoid FDA 483s by proper configuration and validation of GxP compliant
spreadsheet applications.

This webinar will help you follow the step-by-step instructions in real time as
we configure Excel for audit trails, security features, and data entry
verification. You will get a good understanding of how to validate your
application with minimal documentation.

It is advised to bring your laptop and use Excel for your own needs. This
session will help you save time and cost and make you a superior Excel user.

Course Objectives:

Upon completion of this session, attendees will learn how to:

 * Develop GxP compliant spreadsheet applications
 * Use Excel’s built-in 21 CFR Part 11 features
 * Apply features required for GxP environments without programming macros
 * Follow along as we configure Excel for audit trails, security features, data
   verification, and multiple concurrent users
 * Avoid 483s and Warning Letters
 * Use cell and file protections
 * Reduce validation time and costs
 * Increase compliance while lowering resource needs
 * Validate your application with minimal documentation
 * Understand what does and does not need to be validated
 * Specify and test your application

Areas covered:

1. Why are spreadsheets so popular?

 * Spreadsheet overview
 * What are they used for?

2. Why is compliance a problem?

 * How is it different from a calculator?

3. Developing Part 11 applications

 * Security
 * Versioning
 * Cell protection
 * Data entry checks
 * Audit trail
 * Data output formatting

4. Validation

 * Fill-in-the-blank validation templates
 * Step-by-step validation

5. Using the validated application

 * Maintaining, upgrading, re-validation

6. Examples

 * Requirements
 * Specifications
 * Test cases

7. How to turn on the audit trail

 * How to view the audit trail

Who Will Benefit:

This webinar is intended for professionals in the Medical Device, Biotechnology,
and Pharmaceutical Industry. Personnel in the following roles will benefit:

 * All Excel users in the regulated environment
 * QA Departments
 * QC Departments
 * IT Departments
 * Laboratory staff
 * Managers and Executives

About the instructor:

Computer System Validation’s principal, David Nettleton is an industry leader,
author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation,
and computer system validation. He is involved with the development, purchase,
installation, operation, and maintenance of computerized systems used in
FDA-compliant applications. His most popular book is Risk Based Software
Validation - Ten easy Steps, which provides fill-in-the-blank templates for
completing a COTS software validation project. He has completed more than 300
mission-critical laboratory, clinical, and manufacturing software implementation
projects. Services are available to guide companies to create and maintain the
systems and procedures required to pass regulatory audits: product features,
vendor audits, software validation, SOPs, training, gap analysis, remediation
plans, and project management.

Refund policy:

Attendees may cancel up to two working days prior to the course start date and
the refund will be processed within two working days.

We will process/provide a refund if the webinar is canceled. Refunds will not be
given to participants who do not show up for the webinar. On-demand Recordings
can be requested in exchange. Webinar may be canceled due to lack of enrolment
or unavoidable factors. Attendees will be notified 24 hours in advance if a
cancellation occurs. Substitutions can happen at any time.

If you have any concerns about the content of the webinar and are not satisfied
please contact us at care@thecomplyguide.com


TAGS

 * Online Events
 * Online Classes
 * Online Business Classes
 * #flsa
 * #wage_hour_compliance_2021
 * #fda_csv
 * #fda_data_integrity
 * #fda_sdlc
 * #excel_sheet_compliance
 * #fda_excel_compliance


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THE COMPLY GUIDE

Organizer of Excel Spreadsheets: Ensuring Data Integrity and 21 CFR Part 11
Compliance

Comply Guide is a training and content provider in the regulatory compliance
space.

We partner with organizations and individuals to address their unique learning
needs, provide training and coaching to help them gain complete knowledge about
best practices, SOPs, and regulations pertaining to their jobs and/or industry.

Organizer website
 * Follow
 * Contact

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