The 6 Most Common Problems in FDA Software Validation and Verification

Overview:

Professionals working with FDA-regulated software face numerous challenges when it comes to the validation and verification process. This webinar addresses the six most common pitfalls encountered during the validation process, providing practical insights and strategies to overcome them.

Increased reliance on automated manufacturing and quality systems has escalated the exposure to validation issues. Consider the frustration of discovering a minor software glitch that leads to a costly product recall or the stress of navigating an FDA inspection with incomplete validation documentation. These real-world scenarios underscore the importance of robust validation processes. Many professionals find themselves under intense scrutiny, dealing with the repercussions of validation failures, including 483s and warning letters.

A common pain point is corporate uncertainty and indecision, which often result in inaction and "wheel spinning." This can lead to wasted time and resources, delayed product launches, and significant financial losses. Understanding the intricacies of FDA software validation can be daunting, and the fear of making major mistakes looms large. Whether it's deciphering which data and systems are subject to 21 CFR Part 11 and Annex 11, ensuring compliance with security and audit trail requirements, or managing validation for local, SaaS, and cloud-hosted systems, the challenges are manifold.

This webinar aims to demystify the validation process, helping you avoid these common mistakes and streamline your efforts. You'll gain actionable insights into successfully staffing validation projects and implementing strategies to avoid the most frequent problems. By attending, you'll learn how to ensure your validation processes are not only compliant but also efficient and effective, ultimately safeguarding your organization against costly errors and regulatory setbacks.

Join us to turn potential pitfalls into opportunities for improvement and success, and ensure your validation processes stand up to FDA scrutiny.

Areas covered in the session:

• Which data and systems are subject to 21 CFR Part 11 and Annex 11
• Why compliance makes good business sense.
• Details of FDA regulations/system features as applied to software: security, audit trails, electronic signatures.
• Requirements for local, SaaS, and cloud hosting
• The 6 Most Common Problems in FDA Software Validation & Verification.
• Strategies on how to avoid the most common problems.
• Advice on successful validation project staffing.
• Avoid 483 and Warning Letters.

Why you should attend?

Ensuring compliance with FDA software validation and verification standards is a complex and critical task. This webinar is designed to equip you with the knowledge and tools needed to navigate these challenges effectively. By attending, you will learn how to avoid the six most common mistakes in FDA software validation, which can save your organization significant time, money, and resources. The insights provided will help you address real-world issues, such as minor software glitches that could lead to costly product recalls, and ensure your validation processes are robust and efficient.

Additionally, this webinar offers practical strategies and actionable solutions to help you manage corporate uncertainty and indecision, streamline your validation efforts, and avoid the dreaded 483s and warning letters. You’ll come away with a deeper understanding of FDA regulations, the ability to implement successful validation projects, and the confidence to ensure your software validation processes meet the highest standards of compliance and effectiveness. Don’t miss this opportunity to enhance your skills and safeguard your organization against regulatory setbacks.

Who should attend?

This webinar is designed to benefit following professionals across a wide range of industries regulated by the FDA, including pharmaceuticals, biotechnology, medical devices, healthcare IT, and diagnostics. Whether you are directly involved in software validation and verification or play a role in ensuring regulatory compliance, this webinar will provide valuable insights and practical strategies to enhance your processes.

• Validation Engineers
• Quality Assurance Managers
• Regulatory Affairs Specialists
• Compliance Officers
• IT Managers
• Software Development Managers
• Clinical Data Managers
• Project Managers
• Quality Control Analysts
• Manufacturing Engineers
• R&D Scientists
• Systems Analysts
• Auditors
• Product Managers
• Operations Managers

ABOUT PRESENTER:

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 General Data Protection Regulation (GDPR), software validation, and computer system validation.

Mr. Nettleton 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.

Mr. Nettleton 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.

NOTE FOR ATTENDEES:

Live attendees will receive a WebEx meeting invitation upon successfully completing the registration.

Please note that if you have registered two or more attendees, each participant will receive their own WebEx invitation from the organizer at a later time. The registered user will receive an email from the organizer requesting details for all other participants.

Please be aware that, this particular webinar will not be recorded and will not be available for viewing after the live event has concluded. Therefore, we encourage you to attend the live event to gain full access to the information presented.