This interactive webinar explains how to configure and validate GxP-compliant spreadsheet applications to avoid FDA 483s. Follow the step-by-step instructions as we configure Excel for audit trails, security features, and data entry verification. Understand how to validate your application with minimal documentation. Bring your laptop and use Excel for your own needs. This session will make you a better Excel user, saving you time and costs.
1. Why are spreadsheets so popular?
2. Why is compliance a problem?
3. Developing Part 11 applications.
4. Validation.
5. Using the validated application.
6. Examples.
7. How to turn on the audit trail.
1. Why are spreadsheets so popular?
2. Why is compliance a problem?
3. Developing Part 11 applications.
4. Validation.
5. Using the validated application.
6. Examples.
7. How to turn on the audit trail.
David Nettleton
Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, EU GDPR 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. He has completed more than 300 mission-critical laboratory, clinical, and manufacturing software implementation projects. His most recent book is Software as a Service (SaaS) Risk-Based Validation With Time-Saving Templates, which provides fill-in-the-blank templates for completing a COTS software validation project.
Effective Onboarding: How to Welcome, Engage, and Retain Ne…
6-Hour Virtual Seminar on Learning the Highlights of Excel …
Impact Assessments For Supplier Change Notices
Developing an FDA/ISO Compliant Quality Management System
Aligning Your HR Strategy with Your Business Strategy
Accounting For Non Accountants : Debit, Credits And Financi…
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Managing Difficult Employee Conversations
Dealing With Difficult People In Life & Work
Predictive Accounting: Driver-Based Budgeting And Rolling F…
Pay Equity Changes for 2024! What Employers Need to Know to…
Leader Branding: How to Communicate with Confidence to Attr…
Data Integrity and Privacy: Compliance with 21 CFR Part 11,…
Project Management for Non-Project Managers - How to commun…
Why EBITDA Doesn't Spell Cash Flow and What Does
Design Verification, Validation and Testing for Medical Dev…
FFIEC BSA/AML Examination Manual: What Compliance Officers …
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Employee or Independent Contractor – U.S DOL Announces 2024…
Human Factors Usability Studies Following ISO 62366 and FDA…
Best Practices in Complaint Management for Regulatory Compl…
Ensuring Safe and Effective Pharmaceutical Products: A Comp…
Embracing Diversity and Inclusion in Talent Acquisition
Form W-9 Compliance to Avoid Penalties: TIN Verification, B…
Tattoos, hijabs, piercings, and pink hair: The challenges …
Gossip-Free: Leadership Techniques to Quell Office Chatter
Updated Metro 2®, e-OSCAR and the New Tougher FCRA/CFPB Com…
Understanding and Analyzing Financial Statements
Divorce, Adoption and Other Special Tax Topics
Design History File (DHF), the Device Master Record (DMR) a…
Is Your Culture Working For or Against Your Success? If You…
With Mandatory Paid Leave Gaining Ground Is It Time To Do A…
Setting up Quality System for FDA Regulated Products: Tips …
Marketing to Medicare or Medicaid Beneficiaries - What You …
The Five Cs Of Commercial Credit: The Basic Elements Of Cre…
Sunshine Act Reporting - Clarification for Clinical Research
Documenting Misconduct that Will Stand Up in Court
Stress, Change And Team Resilience Through Humor: An Intera…
Managing Toxic & Other Employees Who have Attitude Issues
FDA Regulation of Artificial Intelligence/ Machine Learning
Pharma 4.0: Next Generation Technology Approach to GxP Prod…
Excel - Lists and Tables - A Beginner's Guide to Managing L…
Patient Gifts, Discounts and Freebies: What You Can and Can…