This Seminar describes the validation planning process with particular emphasis on avoiding six common pitfalls. Increased use of software from automated manufacturing and quality systems means increased exposure.
Most recalls can be traced back to computerized equipment, exposing the validation process to scrutiny. Corporate uncertainty leads to inaction and "wheel spinning." Many companies struggle with understanding how to avoid major mistakes when validating software to FDA standards.
This Seminar covers the fundamentals of 21 CFR Part 11, software validation, and computer system validation. It provides details for company compliance including GAMP, qualification, and validation. It teaches the Part 11 industry standards for SOPs, security, data transfer, audit trails, and electronic signatures. The webinar details the common problems and how to avoid them.
Avoid the 6 most common problem associated with Part 11 and Annex 11 compliance. Learn how to efficiently create the specific documents required to implement data integrity requirements.
Avoid the 6 most common problem associated with Part 11 and Annex 11 compliance. Learn how to efficiently create the specific documents required to implement data integrity requirements.
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.
Transform Data into Insights: A Beginners Guide to Excel Pi…
Leadership: Strategic Planning and Decision Making
Onboarding Best Practices for 2025: Proven Strategies to Po…
Seeking Truth: Detecting Truth, Lies and Deception in a Wor…
Managing Difficult Employee Conversations
Copilot and HR: An Introduction for HR Professionals
How to Document Employee Discussions and Why it is Important
Dealing With Difficult People In Life & Work
How to Write Effective Audit Observations: The Principles f…
OSHA Requirements for Supervisors, Project Leaders & HR - W…
FDA Compliance And Laboratory Computer System Validation
4-Hour Virtual Seminar on Transformational Leadership - The…
3-Hour Virtual Boot Camp on Easier Excel Automation with VB…
2025 Handbook Overhaul: Navigating Critical Updates! Federa…
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
Negotiating Skills For Professional Results - Winning Strat…
Building Thriving Teams: Proactive Strategies for Managers …
Designing Employee Experiences to Build a Culture of Compli…
Empowering Conflict Resolution: Letting Go to Gain Control
Navigating Alcohol and Drug Addiction Protections Under the…
President Trumps Executive Orders And What They Mean to Emp…
The Anti-Kickback Statute: 2025 - Year in Review
FDA Technology Modernization Action Plan (TMAP) and Impact …
Form W-9 Compliance: TIN Verification, B Notices, and Avoid…
Workplace Investigations 101: How to Conduct your Investiga…
50+ new Excel features so far this decade
FDA Regulation of Artificial Intelligence/ Machine Learning
From Challenges to Compliance: Understanding Dietary Supple…
Utilizing HR Metrics to Illustrate & Improve Human Resource…
Do's and Don'ts of Documenting Employee Behaviour, Performa…
The Importance of the first 5 seconds when presenting
Why EBITDA Doesn't Spell Cash Flow and What Does
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
Policy Pops: Navigating DEI in the 2025 Workplace: Strategi…
Impact Assessments For Supplier Change Notices
The Monte Carlo Simulations in Excel for Risky Investments
Understanding the incredible uses and fallbacks of ChatGPT
California Meal and Rest Breaks: What You Don't Know Can Co…
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
Onboarding is NOT Orientation - How to Improve the New Empl…
Gossip-Free: Leadership Techniques to Quell Office Chatter
Female to Female Hostility @Workplace: All you Need to Know
6-Hour Virtual Seminar on Learning the Highlights of Excel …