Computer System Validation Boot Camp®

Computerized Systems Validation Course Description

This live training webinar includes the following for each registered attendee:

• 2 Day CSV Training Session
• A copy of the presentation slides by download
• A certificate of participation for attendee training records
• Q/A Session
• Free Handouts on CSV

Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.

The approach to developing software, performing validation and maintaining a system in a validated state through its entire life cycle should be carefully considered in order to meet changing needs. This seminar will include a comparison of the agile and waterfall methodologies, along with the pros and cons of each. There may not be one size that fits all, and so it is important to understand what needs to be considered when making such a determination.

We’ll also cover COTS, SaaS, IaaS, PaaS, and cloud services, indicating the benefits and risks of each model. In discussing these hardware and software options, we’ll include the best practices for meeting FDA’s requirements for validation, 21 CFR Part 11, as applicable, and data integrity. Part of the session will identify the FDA’s current concerns and how to ensure your systems will meet their expectations.

Day 1:

Module 1: CSV Methods and Models

• GxP Systems
• Computer System Validation (CSV)
• Common SDLC Methodologies
• GAMP®5 “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
• GAMP®5 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

Who will benefit?

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.

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
  

How to Attend:

All WCS Webinars live training programs audio and visuals are delivered via Go to Webinar with a basic system requirement of a computer with internet access. You do not require a Go to Webinar account to join WCS Webinars’ live training courses, participants receive an email invitation that provides the access you need to join the meeting.