Online Computer System Validation (CSV/CSA) Course: Navigating Changing Landscapes - 21 CFR Part 11, Data Integrity/Privacy Compliance for FDA-Regulated Systems

Dublin, Oct. 06, 2023 (GLOBE NEWSWIRE) -- The "Computer System Validation (CSV/CSA), 21 CFR Part 11, Data Integrity/Privacy Compliance for FDA-Regulated Systems" training has been added to's offering.

In today's fast-evolving technological landscape, organizations face the imperative to reevaluate their business models. What were once structured and predictable operations are now characterized by complexity and unpredictability. Patients and customers are more informed and hold higher expectations than ever before. As such, work practices and tools must adapt to meet these evolving challenges head-on.

Join us for an insightful webinar that explores the shifting paradigms of software development, validation, and system maintenance in a continuously changing environment. This session will offer a comprehensive comparison of agile and waterfall methodologies, highlighting their respective advantages and disadvantages. Recognizing that a one-size-fits-all approach may not be suitable, this webinar will guide you in making informed decisions when choosing the right methodology.

Additionally, we will delve into the world of Commercial Off-The-Shelf (COTS) solutions, Software-as-a-Service (SaaS), Infrastructure-as-a-Service (IaaS), Platform-as-a-Service (PaaS), and cloud services, uncovering the benefits and risks associated with each model. Throughout the discussion on hardware and software options, we will emphasize best practices for aligning with FDA requirements for validation, including compliance with 21 CFR Part 11 and data integrity standards.

This session will also shed light on the FDA's current areas of concern and how to ensure that your systems meet their expectations.

Key Takeaways:

  • Learn how to leverage modern technology while remaining compliant with FDA regulations for computer systems and data.
  • Explore the modernization of the System Development Life Cycle (SDLC) with an agile approach, in alignment with FDA's draft guidance for Computer Software Assurance (CSA).
  • Understand the pros and cons of different validation approaches and industry best practices for success.
  • Gain insights into validating systems to meet 21 CFR Part 11 and data integrity compliance.
  • Navigate the complexities of compliance with data privacy laws, including HIPAA, GDPR, and other privacy regulations.
  • Get an overview of spreadsheet validation and streamline the validation process for commonly used tools like MS Excel and Google Sheets.

Areas Covered

  • Learn how to identify "GxP" Systems
  • Learn about FDA's current thinking about technology and software development, and how this will impact industry
  • Discuss the current state of Computer System Validation (CSV) approach based on FDA requirements
  • Learn about the System Development Life Cycle (SDLC) approach to validation and how this can be modernized through a more agile approach, including automated testing for continuous validation
  • Learn about cloud services and cloud service providers to optimize your experience
  • Learn ways to validate in the cloud without compromising quality or compliance
  • Learn the pros and cons of an agile vs. waterfall approach
  • We will discuss cloud computing and Software-as-a-Service (SaaS), Infrastructure-as-a-Service (IaaS), and Platform-as-a-Service (PaaS) systems that can be embraced and validated effectively
  • Discuss the best practices for documenting computer system validation efforts, whether using a waterfall or agile approach, including requirements, design, development, testing and operational maintenance procedures, including ways to improve efficiency and effectiveness of managing related documentation
  • Understand the best approach to Installation Qualification (IQ) testing when the system components are not on premise, but are in the cloud
  • Understand how to maintain a system in a validated state through the system's entire life cycle in a more cost-effective manner, applying an agile continuous validation approach
  • Learn how to assure the integrity of data that supports GxP work, despite changes and advances in new technology
  • Discuss the importance of "GxP" documentation that complies with FDA requirements
  • Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state
  • Know the regulatory influences that lead to FDA's current thinking at any given time
  • Learn about current trends in FDA compliance and enforcement
  • Finally, understand the industry best practices that will enable you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle
  • Q&A

Who Should Attend:

Personnel in the following roles will benefit:

  • Information Technology Analysts
  • Information Technology Developers and Testers
  • Software Quality Assurance Professionals
  • QC/QA Managers and Analysts
  • Analytical Chemists
  • Compliance and Audit Managers
  • Laboratory Managers
  • Automation Analysts
  • Manufacturing Specialists and Managers
  • Supply Chain Specialists and Managers
  • Regulatory Affairs Specialists
  • Regulatory Submissions Specialists
  • Risk Management Professionals
  • Clinical Data Analysts
  • Clinical Data Managers
  • Clinical Trial Sponsors
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders/Subject Matter Experts
  • Business System/Application Testers
  • Vendors responsible for software development, testing and maintenance
  • Vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.

Key Topics Covered:

Module 1: CSV Methods and Models

  • GxP Systems
  • Computer System Validation (CSV)
  • Common SDLC Methodologies
  • GAMP5 "V" Model
  • Computer System Validation (CSV) vs. Computer Software Assurance (CSA)
  • Critical Thinking
  • Waterfall vs. Agile Methodology

Module 2: Software and Services

  • Computer Off-the-Shelf (COTS) Software
  • Cloud Systems
  • Software as a Service (SaaS)
  • Platform as a Service (PaaS) & Infrastructure as a Service (IaaS)
  • Single Sign On (SSO)
  • Medical Devices using Software.
  • Software-as-a-Medical Device (SaaMD)
  • Mobile Devices
  • Spreadsheet Validation

Module 3: CSV Planning

  • Validation Plan
  • Rationale for Validation Testing
  • GAMP5 System Categorization
  • Risk Assessment and Mitigation

Module 4: System Requirements and Design

  • Requirements Development
  • User Requirements Specification (URS)
  • Functional Requirements Specification (FRS)
  • System Design/Configuration Management Specification (SDS/CMS)

Module 5: IQ, OQ, PQ Test Planning & Execution

  • Validation Protocols - IQ, OQ, PQ
  • Validation Test Execution
  • Validation Test Summary Report

Module 6: Test and Validation Reports

  • Requirements Traceability Matrix (RTM)
  • Validation Summary Report
  • System Acceptance and Release Notification

Day 1 Q&A Session

Day 2:

Module 7: CSV Operations and Maintenance

  • Maintaining a System in a Validated State
  • Disaster Recovery Planning
  • Business Continuity Planning
  • Incident Reporting, Investigation, and Remediation
  • Record Retention
  • System Retirement Challenges
  • Legacy Systems and Integration
  • Spreadsheet Validation

Module 8: CSV Supporting Components

  • Good Documentation Practices (GDPs)
  • Training
  • Organizational Change Management (OCM)
  • Validation Policies and Procedures

Module 9: Managing FDA-Regulated Data

  • 21 CFR Part 11 Guidance
  • Electronic Records/Signatures (ER/ES) Requirements
  • Data Integrity: ALCOA+ Principles
  • Data Life Cycle Approach
  • Data Governance
  • Data Privacy: HIPAA, GDPRs, et al

Module 10: Vendor Audit

  • Audit Preparation
  • Audit Execution
  • Post-Audit
  • Vendor Contracts and Service Level Agreements (SLAs)

Module 11: FDA Trends

  • Regulatory Influences
  • Regulatory Trends
  • Current Compliance and Enforcement Trends

Module 12: Inspection Preparation

  • FDA Inspection Readiness
  • Industry Best Practices

Day 2 Q&A Session

Module 13: CSV Exercises

  • Exercise 1: CSV
  • Exercise 2: Validation Plan (VMP) Writing
  • Exercise 3: Risk Assessment
  • Exercise 4: FDA Requirements for ER/ES
  • Exercise 5: Interviews and URS/FRS Writing
  • Exercise 6: IQ, OQ, PQ Test Protocol Writing
  • Exercise 7: RTM Writing
  • Exercise 8: Be the Consultant


Carolyn Troiano
Webinar/Seminar/Workshop Instructor in FDA Compliance Training

Carolyn Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs

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