Mastering Verification vs. Validation: Ensuring Compliance for Products, Processes, and QMS Software
Learn How to Implement Risk-based V&V Across Your Product and Process Software!
Instructor :
John E Lincoln
Webinar ID:
12903
Date: OCT 25, 2024 (FRI)
Start Time: 10 AM PT - 11 AM PT
Duration: 1 Hr.
What will you learn
-
- Understand Verification Vs. Validation And Meet FDA Compliance Expectations
- Develop A Comprehensive And Actionable Project V&V Plan
- Master FDA-Preferred Documentation Models And Key Compliance Elements
- Validate Product, Process, And Equipment Software For Regulatory Compliance
- Apply DQ, IQ, OQ, And PQ In Validation Processes
- Learn White Box Vs. Black Box Software Validation Approaches
- Incorporate IEC 62304, GAMP, And ….
-
- Understand Verification Vs. Validation And Meet FDA Compliance Expectations
- Develop A Comprehensive And Actionable Project V&V Plan
- Master FDA-Preferred Documentation Models And Key Compliance Elements
- Validate Product, Process, And Equipment Software For Regulatory Compliance
- Apply DQ, IQ, OQ, And PQ In Validation Processes
- Learn White Box Vs. Black Box Software Validation Approaches
- Incorporate IEC 62304, GAMP, And Global Standards For Compliance
Course Description
As we approach 2025, the verification and validation (V&V) of regulated software are under tighter scrutiny by the U.S. FDA and other global regulatory agencies. Staying ahead of compliance requirements is no longer optional—it’s a necessity.
This 60-minute webinar delivers a comprehensive roadmap to mastering V&V, ensuring your organization aligns with the latest standards and regulatory expectations.
What You’ll Learn:
- Essential guidelines and updated standards, including:
- FDA guidance and end-of-2024 updates.
- GAMP (Good Automated Manufacturing Practice)
- 21 CFR Part 11 (Electronic Records/Signatures)
- IEC 62304 (Software Lifecycle Processes)
- ISO 14971 and ICH Q9 (Risk Management Frameworks)
- How to effectively plan, execute, and document software validations to maintain compliance.
- The critical role of risk-based validation in addressing regulatory requirements.
- Practical strategies to implement these principles in your current processes for 2024 and beyond.
This webinar is designed for professionals responsible for:
-
- As-Product Software: Standalone or integrated software products.
- In-Product Software: Embedded systems within medical devices or other regulated products.
- Process/Production/Test Software: Tools supporting manufacturing and testing workflows.
- Quality Management Systems (QMS): Software ensuring CGMP compliance and quality operations.
As we close out 2024, it’s critical to ensure your software V&V process is ready to meet evolving regulatory demands. Gain the knowledge and tools you need to build and document robust validations, reduce risk, and maintain compliance in 2025 and beyond.
Prepare for the future—secure your compliance now!
Register Today to master V&V.
As we approach 2025, the verification and validation (V&V) of regulated software are under tighter scrutiny by the U.S. FDA and other global regulatory agencies. Staying ahead of compliance requirements is no longer optional—it’s a necessity.
This 60-minute webinar delivers a comprehensive roadmap to mastering V&V, ensuring your organization aligns with the latest standards and regulatory expectations.
What You’ll Learn:
- Essential guidelines and updated standards, including:
- FDA guidance and end-of-2024 updates.
- GAMP (Good Automated Manufacturing Practice)
- 21 CFR Part 11 (Electronic Records/Signatures)
- IEC 62304 (Software Lifecycle Processes)
- ISO 14971 and ICH Q9 (Risk Management Frameworks)
- How to effectively plan, execute, and document software validations to maintain compliance.
- The critical role of risk-based validation in addressing regulatory requirements.
- Practical strategies to implement these principles in your current processes for 2024 and beyond.
This webinar is designed for professionals responsible for:
-
- As-Product Software: Standalone or integrated software products.
- In-Product Software: Embedded systems within medical devices or other regulated products.
- Process/Production/Test Software: Tools supporting manufacturing and testing workflows.
- Quality Management Systems (QMS): Software ensuring CGMP compliance and quality operations.
As we close out 2024, it’s critical to ensure your software V&V process is ready to meet evolving regulatory demands. Gain the knowledge and tools you need to build and document robust validations, reduce risk, and maintain compliance in 2025 and beyond.
Prepare for the future—secure your compliance now!
Register Today to master V&V.
Why you should attend
In healthcare and life sciences landscape, software plays a critical role in the development and operation of medical devices, pharmaceutical processes, and quality management systems.
As innovation accelerates—from medical imaging systems to thought-controlled devices—ensuring compliance with regulatory standards has never been more urgent.
However, with greater software utilization comes intense scrutiny from the U.S. FDA and other global regulators. Nearly all software quality issues originate during the design, testing, and validation phases. Regulatory bodies are becoming more adept at identifying shortcomings in verification and validation (V&V) processes, making robust and compliant practices an absolute necessity.
Why This Webinar is a Must-Attend:
-
- Ensure Compliance with FDA Standards: Gain insights into the FDA’s preferred documentation models for ERP systems, in-device software, process controls, and cGMP data management.
- Avoid Costly Mistakes: Learn how to mitigate compliance risks by addressing V&V challenges in design, testing, and validation phases.
- Adapt to Increased Regulatory Oversight: Stay ahead of auditors by aligning your practices with 21 CFR Part 11, EU Annex 11, and other key regulations.
- Improve Product Safety and Quality: Understand how effective V&V directly impacts the safety, efficacy, and reliability of your medical products.
- Advance Your Career: Build expertise in risk-based validation and regulatory compliance—skills that are in high demand across the industry.
This webinar is ideal for professionals in medical devices, pharmaceuticals, biologics, and dietary supplements looking to enhance their software V&V practices and keep pace with evolving compliance requirements.
Equip yourself with the tools and knowledge needed to succeed in this highly regulated, resource-constrained environment.
Enroll now to stay ahead in the race for innovation and compliance!
Join Now!
In healthcare and life sciences landscape, software plays a critical role in the development and operation of medical devices, pharmaceutical processes, and quality management systems.
As innovation accelerates—from medical imaging systems to thought-controlled devices—ensuring compliance with regulatory standards has never been more urgent.
However, with greater software utilization comes intense scrutiny from the U.S. FDA and other global regulators. Nearly all software quality issues originate during the design, testing, and validation phases. Regulatory bodies are becoming more adept at identifying shortcomings in verification and validation (V&V) processes, making robust and compliant practices an absolute necessity.
Why This Webinar is a Must-Attend:
-
- Ensure Compliance with FDA Standards: Gain insights into the FDA’s preferred documentation models for ERP systems, in-device software, process controls, and cGMP data management.
- Avoid Costly Mistakes: Learn how to mitigate compliance risks by addressing V&V challenges in design, testing, and validation phases.
- Adapt to Increased Regulatory Oversight: Stay ahead of auditors by aligning your practices with 21 CFR Part 11, EU Annex 11, and other key regulations.
- Improve Product Safety and Quality: Understand how effective V&V directly impacts the safety, efficacy, and reliability of your medical products.
- Advance Your Career: Build expertise in risk-based validation and regulatory compliance—skills that are in high demand across the industry.
This webinar is ideal for professionals in medical devices, pharmaceuticals, biologics, and dietary supplements looking to enhance their software V&V practices and keep pace with evolving compliance requirements.
Equip yourself with the tools and knowledge needed to succeed in this highly regulated, resource-constrained environment.
Enroll now to stay ahead in the race for innovation and compliance!
Join Now!
Areas Covered
-
- Understanding Verification Vs. Validation – Meeting FDA Expectations:
Learn the fundamental differences between verification and validation, and gain insights into how the FDA evaluates compliance during audits. - Developing an Effective Project V&V Plan:
Discover how to create a comprehensive and actionable V&V plan, tailored to meet both regulatory requirements and project objectives. - FDA-Accepted Documentation “Model”:
Explore the documentation framework preferred by the FDA, including key elements to ensure your records withstand regulatory scrutiny. - Mastering the FDA’s 11 Key V&V Documentation Elements:
Delve into the 11 critical documentation components that are required for a compliant V&V process. - Product and Process/Test Facilities/Equipment Software V&V:
Understand how to validate software used in products, manufacturing processes, and test equipment to ensure end-to-end compliance. - Applying DQ, IQ, OQ, and PQ (Or Their Equivalents):
Learn when and how to implement Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for effective validation. - “White Box” Vs. “Black Box” Validations:
Gain insights into the application of white box testing (internal structure validation) and black box testing (functional validation) in software V&V. - Incorporating IEC 62304, GAMP, and Other Global Standards:
Explore additional frameworks, including IEC 62304 for software lifecycle processes and GAMP for automated systems, to strengthen your compliance strategies.
- Understanding Verification Vs. Validation – Meeting FDA Expectations:
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.
-
- Understanding Verification Vs. Validation – Meeting FDA Expectations:
Learn the fundamental differences between verification and validation, and gain insights into how the FDA evaluates compliance during audits. - Developing an Effective Project V&V Plan:
Discover how to create a comprehensive and actionable V&V plan, tailored to meet both regulatory requirements and project objectives. - FDA-Accepted Documentation “Model”:
Explore the documentation framework preferred by the FDA, including key elements to ensure your records withstand regulatory scrutiny. - Mastering the FDA’s 11 Key V&V Documentation Elements:
Delve into the 11 critical documentation components that are required for a compliant V&V process. - Product and Process/Test Facilities/Equipment Software V&V:
Understand how to validate software used in products, manufacturing processes, and test equipment to ensure end-to-end compliance. - Applying DQ, IQ, OQ, and PQ (Or Their Equivalents):
Learn when and how to implement Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for effective validation. - “White Box” Vs. “Black Box” Validations:
Gain insights into the application of white box testing (internal structure validation) and black box testing (functional validation) in software V&V. - Incorporating IEC 62304, GAMP, and Other Global Standards:
Explore additional frameworks, including IEC 62304 for software lifecycle processes and GAMP for automated systems, to strengthen your compliance strategies.
- Understanding Verification Vs. Validation – Meeting FDA Expectations:
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
Reap the Rewards of This Training Individually or as a Group for Collective Growth!
-
- Regulatory Leaders Striving to Ensure Software Compliance and Avoid Audit Risks
- Quality Assurance Professionals Aiming to Strengthen Risk-Based Validation Processes
- Compliance Managers Focused on Streamlining Documentation for Regulatory Readiness
- Department Heads Seeking to Enhance Operational Efficiency Through Effective V&V
- Software Validation Specialists Solving Complex Challenges in Testing and Validation
- Training Heads Designing Comprehensive Learning Paths for Technical Teams
- HR Professionals Supporting Workforce Development in Regulatory Environments
- Medical Device Manufacturers Addressing Software Compliance Challenges for FDA Approval
- Pharma and Biotech Professionals Focused on Ensuring CGMP Compliance
Reap the Rewards of This Training Individually or as a Group for Collective Growth!
-
- Regulatory Leaders Striving to Ensure Software Compliance and Avoid Audit Risks
- Quality Assurance Professionals Aiming to Strengthen Risk-Based Validation Processes
- Compliance Managers Focused on Streamlining Documentation for Regulatory Readiness
- Department Heads Seeking to Enhance Operational Efficiency Through Effective V&V
- Software Validation Specialists Solving Complex Challenges in Testing and Validation
- Training Heads Designing Comprehensive Learning Paths for Technical Teams
- HR Professionals Supporting Workforce Development in Regulatory Environments
- Medical Device Manufacturers Addressing Software Compliance Challenges for FDA Approval
- Pharma and Biotech Professionals Focused on Ensuring CGMP Compliance
Instructor Profile
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.
John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry – working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.
