Computerized Systems Validation, Data Integrity & Cloud Computing In Pharma

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.

2 Day Course Agenda

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

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.
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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.