Completed at the discretion of the attendee. Note that both questions and answers are provided for each exercise. (100 Questions/Answers)
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.
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.
Course Content
Day 1Day 2Day 3
Module 1: CSV Methods and Models
Module 2: Software and Services
Module 3: CSV Planning
Module 4: System Requirements and Design
Day 1
Module 5: IQ, OQ, PQ Test Planning & Execution
Module 6: Test and Validation Reports
Module 7: CSV Operations and Maintenance
Module 8: CSV Supporting Components
Module 9: Managing FDA-Regulated Data
Module 10: Vendor Audit
Module 11: FDA Trends
Module 12: Inspection Preparation
Day 3
Module 13: CSV Exercises
Agenda
Day 1Module 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
- 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
- Validation Plan
- Rationale for Validation Testing
- GAMP®5 System Categorization
- Risk Assessment and Mitigation
- Requirements Development
- User Requirements Specification (URS)
- Functional Requirements Specification (FRS)
- System Design/Configuration Management Specification (SDS/CMS)
Day 2
Module 5: IQ, OQ, PQ Test Planning & Execution
- Validation Protocols - IQ, OQ, PQ
- Validation Test Execution
- Validation Test Summary Report
- Requirements Traceability Matrix (RTM)
- Validation Summary Report
- System Acceptance and Release Notification
- 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
- 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
- Audit Preparation
- Audit Execution
- Post-Audit
- Vendor Contracts and Service Level Agreements (SLAs)
- Regulatory Influences
- Regulatory Trends
- Current Compliance and Enforcement Trends
- FDA Inspection Readiness
- Industry Best Practices
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
Course Provider
Carolyn Troiano,
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
