Computer System Validation: The 6 Most Common Problems in FDA Software Validation and Verification
Transform Regulatory Hurdles into Opportunities for Innovation and Growth!
Instructor :
David Nettelton
Webinar ID:
3772
Date: OCT 15, 2024 (TUE)
Start Time: 10 AM PT - 12 NOON PT
Duration: 2 Hrs.
What you will learn
-
- Coverage Of 21 CFR Part 11 And Annex 11 Clarified.
- Data Integrity Compliance As A Strategic Business Advantage.
- Hosting Essentials For Local, SaaS, And Cloud.
- Overcoming Top FDA Software Validation Challenges.
- Effective Team Assembly For …
-
- Coverage Of 21 CFR Part 11 And Annex 11 Clarified.
- Data Integrity Compliance As A Strategic Business Advantage.
- Hosting Essentials For Local, SaaS, And Cloud.
- Overcoming Top FDA Software Validation Challenges.
- Effective Team Assembly For Validation Projects.
- Preventing Regulatory Non-Compliance And Penalties.
- Understanding And Implementing Industry Standards.
Course Description
In an era where regulatory landscapes are rapidly evolving, “Stay Ahead: Master the 2024 FDA Software Validation Challenges Before They Impact You” offers an unparalleled deep dive into the complexities of FDA software validation and verification.
With 2024 poised to introduce significant shifts in regulations, being prepared is no longer just an option—it’s a necessity.
What You Will Gain
Guided by the esteemed Computer System Validation expert, David Nettleton, this interactive session will empower you with:
-
- Discover the Latest Updates: Updates on FDA software validation and verification regulations for 2024.
- Foundational Insights: Grasp the essentials of 21 CFR Part 11, software validation, and computer system validation.
- Compliance Roadmap: Learn the intricacies of GAMP, qualification, and validation processes to ensure company compliance.
- Industry Standards Mastery: Master the Part 11 industry standards for SOPs, security, data transfer, audit trails, and electronic signatures.
- Problem-Solving Strategies: Uncover the common challenges and learn how to sidestep them, ensuring a smoother validation journey.
In an era where technological sophistication and regulatory demands are at their peak, understanding how to effectively validate software according to FDA standards is crucial.
Whether you’re looking to refine your approach, update your knowledge on the latest trends, or simply avoid costly mistakes, this webinar is your gateway to achieving compliance excellence.
Equip yourself with the knowledge and skills to navigate the complexities of FDA software validation and verification. Unlock the door to regulatory success and elevate your organization’s compliance stance.
Enroll Now!
In an era where regulatory landscapes are rapidly evolving, “Stay Ahead: Master the 2024 FDA Software Validation Challenges Before They Impact You” offers an unparalleled deep dive into the complexities of FDA software validation and verification.
With 2024 poised to introduce significant shifts in regulations, being prepared is no longer just an option—it’s a necessity.
What You Will Gain
Guided by the esteemed Computer System Validation expert, David Nettleton, this interactive session will empower you with:
-
- Discover the Latest Updates: Updates on FDA software validation and verification regulations for 2024.
- Foundational Insights: Grasp the essentials of 21 CFR Part 11, software validation, and computer system validation.
- Compliance Roadmap: Learn the intricacies of GAMP, qualification, and validation processes to ensure company compliance.
- Industry Standards Mastery: Master the Part 11 industry standards for SOPs, security, data transfer, audit trails, and electronic signatures.
- Problem-Solving Strategies: Uncover the common challenges and learn how to sidestep them, ensuring a smoother validation journey.
In an era where technological sophistication and regulatory demands are at their peak, understanding how to effectively validate software according to FDA standards is crucial.
Whether you’re looking to refine your approach, update your knowledge on the latest trends, or simply avoid costly mistakes, this webinar is your gateway to achieving compliance excellence.
Equip yourself with the knowledge and skills to navigate the complexities of FDA software validation and verification. Unlock the door to regulatory success and elevate your organization’s compliance stance.
Enroll Now!
Why you should attend
The landscape of FDA software validation is daunting and constantly changing.
This webinar is designed to equip you with the knowledge and tools to not only comply with upcoming regulations but to use these changes as a springboard for operational excellence and market leadership.
Recent studies show that over 60% of Life Sciences companies cite keeping up with regulatory changes as their top challenge. Yet, those who adapt quickly see an average 15% increase in operational efficiency. This webinar is your key to joining the ranks of these high performers.
David Nettleton, a titan in the realm of Computer System Validation, invites you to a comprehensive session where you’ll discover:
-
- Understand the implications of the 2024 FDA software validation changes for your business.
- Avoid costly non-compliance issues by learning from experts who’ve been in the trenches.
- Proactive Strategies: Equip yourself with proven strategies to circumvent the 6 most common pitfalls in achieving compliance with Part 11 and Annex 11.
- Document Mastery: Learn the art of crafting precise documents essential for implementing data integrity requirements. Streamline your processes, reduce overheads, and enhance operational efficiency by mastering documentation best practices.
Whether you’re looking to demystify the validation process, enhance your compliance posture, or simply stay ahead of regulatory curveballs, David Nettleton’s insights offer invaluable guidance.
Enroll Now!
The landscape of FDA software validation is daunting and constantly changing.
This webinar is designed to equip you with the knowledge and tools to not only comply with upcoming regulations but to use these changes as a springboard for operational excellence and market leadership.
Recent studies show that over 60% of Life Sciences companies cite keeping up with regulatory changes as their top challenge. Yet, those who adapt quickly see an average 15% increase in operational efficiency. This webinar is your key to joining the ranks of these high performers.
David Nettleton, a titan in the realm of Computer System Validation, invites you to a comprehensive session where you’ll discover:
-
- Understand the implications of the 2024 FDA software validation changes for your business.
- Avoid costly non-compliance issues by learning from experts who’ve been in the trenches.
- Proactive Strategies: Equip yourself with proven strategies to circumvent the 6 most common pitfalls in achieving compliance with Part 11 and Annex 11.
- Document Mastery: Learn the art of crafting precise documents essential for implementing data integrity requirements. Streamline your processes, reduce overheads, and enhance operational efficiency by mastering documentation best practices.
Whether you’re looking to demystify the validation process, enhance your compliance posture, or simply stay ahead of regulatory curveballs, David Nettleton’s insights offer invaluable guidance.
Enroll Now!
Areas Covered
-
- Identifying Data and Systems Covered by 21 CFR Part 11 and Annex 11
- The Business Case for Data Integrity Compliance
- Hosting Requirements: Local, SaaS, and Cloud Solutions
- Top 6 Challenges in FDA Software Validation & Verification
- Proactive Strategies to Circumvent Validation and Verification Issues
- Keys to Effective Validation Project Team Assembly
- Strategies to Prevent 483s and Warning Letters
- Distinguishing Between Software That Requires Validation and That Which Does Not
- Insights into GAMP, Qualification, and Validation Processes
- Deciphering Regulatory Intent Beyond Textual Interpretations
- Navigating Part 11 Compliance: SOPs, Product Features, and Documentation
- Adhering to Industry Standards for Security, Data Transfer, Audit Trails, and Electronic Signatures
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.
-
- Identifying Data and Systems Covered by 21 CFR Part 11 and Annex 11
- The Business Case for Data Integrity Compliance
- Hosting Requirements: Local, SaaS, and Cloud Solutions
- Top 6 Challenges in FDA Software Validation & Verification
- Proactive Strategies to Circumvent Validation and Verification Issues
- Keys to Effective Validation Project Team Assembly
- Strategies to Prevent 483s and Warning Letters
- Distinguishing Between Software That Requires Validation and That Which Does Not
- Insights into GAMP, Qualification, and Validation Processes
- Deciphering Regulatory Intent Beyond Textual Interpretations
- Navigating Part 11 Compliance: SOPs, Product Features, and Documentation
- Adhering to Industry Standards for Security, Data Transfer, Audit Trails, and Electronic Signatures
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.
Who is this course for
Maximize the Learning Experience in A Group Setting!
-
- System owners – responsible for keeping individual systems in validation
- Computer system users
- QA / QC managers, executives and personnel
- IT / IS managers and personnel
- Validation specialists
- Laboratory staff
- Managers
- GMP, GCP, GLP professionals
Maximize the Learning Experience in A Group Setting!
-
- System owners – responsible for keeping individual systems in validation
- Computer system users
- QA / QC managers, executives and personnel
- IT / IS managers and personnel
- Validation specialists
- Laboratory staff
- Managers
- GMP, GCP, GLP professionals
Instructor Profile
David Nettleton, Computer System Validation’s principal, 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.
