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:
11427
Date: NOV 20, 2024 (WED)
Start Time: 10 AM PT - 11 AM PT
Duration: 1 Hr.
What you will learn
- Understanding Verification Vs. Validation – FDA Compliance Expectations
- Developing An Effective Project V&V Plan
- Utilizing An FDA-Accepted Documentation “Model”
- Implementing The FDA’s 11 Key V&V Documentation Elements
- Conducting Product, Process, And Equipment Software V&V
- Applying DQ, IQ, OQ, PQ – When …
- Understanding Verification Vs. Validation – FDA Compliance Expectations
- Developing An Effective Project V&V Plan
- Utilizing An FDA-Accepted Documentation “Model”
- Implementing The FDA’s 11 Key V&V Documentation Elements
- Conducting Product, Process, And Equipment Software V&V
- Applying DQ, IQ, OQ, PQ – When And How
- Executing “White Box” And “Black Box” Validations
- Incorporating IEC 62304, GAMP, And Industry Standards
- Ensuring Compliance Across All V&V Documentation And Processes
Course Description
The verification and validation of regulated software are under increasing scrutiny by the U.S. FDA. This webinar will provide a comprehensive guide to ensuring compliance with critical industry standards and regulations, including:
- FDA guidelines
- GAMP
- 21 CFR Part 11 (“Electronic Records”/”Electronic Signatures”)
- IEC 62304
- ISO 14971/ICH Q9 Product Risk Management models
Key Takeaways:
- Understand how to plan, structure, run, and document acceptable software validations.
- Learn about the importance of risk-based validation as emphasized by the FDA and other regulatory agencies.
- Discover practical approaches to applying these principles in the “real world” environment.
This Webinar Will Cover Software Used In:
- As-Product (software that is part of the product itself)
- In-Product (software embedded in the product)
- Process and/or Production and Test Equipment (software used in manufacturing processes)
- The Quality System/CGMPs (software supporting compliance with quality system regulations)
Why Attend? As a manufacturer, it’s your responsibility to identify and implement these requirements into an effective software V&V process. This webinar will equip you with the knowledge and tools necessary to ensure your software validation processes meet regulatory expectations and maintain compliance.
Join Now!
The verification and validation of regulated software are under increasing scrutiny by the U.S. FDA. This webinar will provide a comprehensive guide to ensuring compliance with critical industry standards and regulations, including:
- FDA guidelines
- GAMP
- 21 CFR Part 11 (“Electronic Records”/”Electronic Signatures”)
- IEC 62304
- ISO 14971/ICH Q9 Product Risk Management models
Key Takeaways:
- Understand how to plan, structure, run, and document acceptable software validations.
- Learn about the importance of risk-based validation as emphasized by the FDA and other regulatory agencies.
- Discover practical approaches to applying these principles in the “real world” environment.
This Webinar Will Cover Software Used In:
- As-Product (software that is part of the product itself)
- In-Product (software embedded in the product)
- Process and/or Production and Test Equipment (software used in manufacturing processes)
- The Quality System/CGMPs (software supporting compliance with quality system regulations)
Why Attend? As a manufacturer, it’s your responsibility to identify and implement these requirements into an effective software V&V process. This webinar will equip you with the knowledge and tools necessary to ensure your software validation processes meet regulatory expectations and maintain compliance.
Join Now!
Why you should attend
In today’s rapidly evolving healthcare landscape, software is integral to the development and operation of medical devices and the management of medical product processes across industries such as pharmaceuticals, medical devices, biologics, and dietary supplements.
From medical imaging to thought-controlled computers, software is at the forefront of innovation, increasingly being utilized for electronic records and e-signatures.
However, with this rise in software usage comes heightened scrutiny from regulatory bodies like the U.S. FDA. The FDA has identified that nearly all software quality issues stem from the design, testing, and validation phases, as the replication of software is generally defect-free.
This makes effective verification and validation (V&V) practices more crucial than ever, especially in today’s resource-constrained industrial environment.
Regulatory auditors are now more adept at identifying and addressing software issues, meaning that your V&V processes must be robust and compliant. This webinar will guide you through the preferred U.S. FDA documentation model for various applications, including ERP systems, in-device and as-device software, process and equipment control, and cGMP data management in line with 21 CFR Part 11 and EU Annex 11 requirements.
By attending, you will gain critical insights into ensuring that your software development and validation processes meet the rigorous standards expected by regulatory authorities, helping you avoid costly compliance issues and ensuring the safety and efficacy of your products.
This session is an essential investment for professionals looking to stay ahead in the highly regulated world of medical software.
Enroll Now!
In today’s rapidly evolving healthcare landscape, software is integral to the development and operation of medical devices and the management of medical product processes across industries such as pharmaceuticals, medical devices, biologics, and dietary supplements.
From medical imaging to thought-controlled computers, software is at the forefront of innovation, increasingly being utilized for electronic records and e-signatures.
However, with this rise in software usage comes heightened scrutiny from regulatory bodies like the U.S. FDA. The FDA has identified that nearly all software quality issues stem from the design, testing, and validation phases, as the replication of software is generally defect-free.
This makes effective verification and validation (V&V) practices more crucial than ever, especially in today’s resource-constrained industrial environment.
Regulatory auditors are now more adept at identifying and addressing software issues, meaning that your V&V processes must be robust and compliant. This webinar will guide you through the preferred U.S. FDA documentation model for various applications, including ERP systems, in-device and as-device software, process and equipment control, and cGMP data management in line with 21 CFR Part 11 and EU Annex 11 requirements.
By attending, you will gain critical insights into ensuring that your software development and validation processes meet the rigorous standards expected by regulatory authorities, helping you avoid costly compliance issues and ensuring the safety and efficacy of your products.
This session is an essential investment for professionals looking to stay ahead in the highly regulated world of medical software.
Enroll Now!
Course Agenda
- Verification or Validation – FDA Expectations
- The Project V&V Plan
- FDA-Accepted Documentation “Model”
- The FDA’s 11 Key V&V Documentation Elements
- Product and Process/Test Facilities/Equipment Software V&V
- When and How to Use DQ, IQ, OQ, PQ (or Their Equivalents)
- “White Box” and “Black Box” Validations
- IEC 62304, GAMP, and Other Considerations
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.
- Verification or Validation – FDA Expectations
- The Project V&V Plan
- FDA-Accepted Documentation “Model”
- The FDA’s 11 Key V&V Documentation Elements
- Product and Process/Test Facilities/Equipment Software V&V
- When and How to Use DQ, IQ, OQ, PQ (or Their Equivalents)
- “White Box” and “Black Box” Validations
- IEC 62304, GAMP, and Other Considerations
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!
-
- Quality Assurance Manager
- Quality Control Supervisor
- Production Manager
- Operations Manager
- Pharmaceutical Manufacturing Manager
- Regulatory Affairs Specialist
- Compliance Officer
- Laboratory Manager
- Process Engineer
- Safety Officer
Reap the Rewards of This Training Individually or as a Group for Collective Growth!
-
- Quality Assurance Manager
- Quality Control Supervisor
- Production Manager
- Operations Manager
- Pharmaceutical Manufacturing Manager
- Regulatory Affairs Specialist
- Compliance Officer
- Laboratory Manager
- Process Engineer
- Safety Officer
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.
