Description:
We will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety. We will walk through the System Development Life Cycle (SDLC) approach to validation, based on risk assessment, and will also discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately.
We will review various approaches to validation, including the traditional Computer System Validation (CSV) approach. We will also discuss Computer Software Assurance (CSA), FDA’s draft guidance for validation. Where CSV is document-driven, CSA is guided by critical thinking, with documentation being the final proof work was done correctly. We will discuss waterfall and agile methodologies for development, testing, configuration, and validation. We will cover automated testing and how it can be incorporated into validation testing. We will also cover technology, including on-premise systems, Computer-Off-the-Shelf (COTS) software, cloud services, and Software-as-a-Service (SaaS) solutions. The best approaches for validating systems in these environments will be discussed.
We will also walk through the entire set of essential policies and procedures, as well as other supporting documentation for operational activities that must be developed and followed to ensure compliance. We will provide an overview of practices to prepare for an FDA inspection, and will also touch on the importance of auditing vendors of computer system hardware, software, tools and utilities, and services.
Finally, we will provide an overview of industry best practices, with a focus on data integrity and risk assessment that can be leveraged to assist in all your GxP work.
Why Should You Attend:
We have used our real-world experience to design a computer system validation course that not only meets FDA expectations for risk-based validation, but also prepares you to implement these practices in your company. The standard operating procedures and validation templates used in class have already been proven at other companies.
We are focused on your comprehension and application of the CSV techniques that will result in efficient, effective, and inspection-ready validation initiatives.
In-Person Seminar going Virtual with increased learner satisfaction.
Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:
- The real-time and live presentation as in in-person events
- Private chat for company-specific conversation – the same as you would get in an in-person seminar
- Opportunities to connect with your peers to share knowledge at a different time and have group discussions
- Live workshop activities
- Live Q&A during the event and offline Q&A assistance after the event
- As usual more content, activities and case studies and now adding homework for a comprehensive understanding
- Certification
Areas Covered:
- GxP Systems
- Computer System Validation (CSV)
- Common SDLC Methodologies
- Computer Software Assurance (CSA)
- Critical Thinking
- GAMP®5 “V” Model
- GAMP®5, Second Edition and alignment with CSA
- GAMP®5 Software Categorization
- Risk Assessment and Management
- CSV Policies and Procedures
- Validation Planning
- Validation Requirements
- Validation Testing
- Requirements Traceability Matrix (RTM)
- 21 CFR Part 11, FDA’s Guidance for Use of Electronic Records and Electronic Signatures (ER/ES)
- Data Integrity
- Data Privacy
- Software-as-a-Service (SaaS) Solutions
- Commercial-Off-the-Shelf (COTS) Software
- Cloud Services
- Automated Testing
- Vendor Audit
- Industry Best Practices
- FDA Trends in Compliance and Enforcement
- Q&A
Who will Benefit:
Personnel in the following roles will benefit:
- Information Technology Analysts
- Information Technology Developers and Testers
- 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 and consultants working in the life sciences industry who are involved in computer system development, implementation, testing, validation, maintenance and compliance
Topic Background:
Computer system validation has been regulated by FDA for more than 40 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or report data.
Electronic records and electronic signatures (ER/ES) came into play through guidelines established by FDA in 1997, and disseminated through 21 CFR Part 11. This code describes the basic requirements for validating and documenting ER/ES capability in systems used in an FDA-regulated environment.
In the early 2000s, FDA recognized they could not inspect every computer system at every regulated company and placed the onus on industry to begin assessing all regulated computer systems based on risk. The level of potential risk, should the system fail to operate properly, needed to be the basis for each company’s approach to developing a validation approach and rationale as part of the planning process. System size, complexity, business criticality, GAMP®5 category and risk rating are the five key components for determining the scope and robustness of testing required to ensure data integrity and product safety.
FDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries. These include all systems that “touch” product, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by FDA. All structured data, including databases, and unstructured data, including documents, spreadsheets, presentations, and image files, audio and video files, amongst others, must be managed and maintained with integrity throughout their entire life cycle.
- Module 1: Computer System Validation (CSV)
- Recognizing GxP Systems
- Validation Foundations
- Validation, Verification, and Qualification
- Module 2: System Development Life Cycle (SDLC)
- Common SDLC Methodologies
- Computer Software Assurance (CSA)
- Critical Thinking
- GAMP®5 “V” Model
- GAMP®5, Second Edition and alignment with CSA
- Module 3: CSV Planning
- Validation Planning
- Rationale for Validation Testing
- GAMP®5 System Categorization
- Risk Assessment and Mitigation
- Module 4: CSV Supporting Components
- Maintaining a System in a Validated State
- Good Documentation Practice (GDP) Training
- Organizational Change Management (OCM)
- CSV Policies and Procedures
- Module 5: System Requirements and Design
- Requirements Development
- User Requirements Specification (URS)
- Functional Requirements Specification (FRS)
- System, or Non-Functional Requirements
- System Design/Configuration Management Specification (SDS/CMS)
- Module 6: IQ, OQ, PQ Test Planning, Execution and Reporting
- Test Protocols and Summary Reports
- Validation Test Execution
- Validation Test Summary Report
- Requirements Traceability Matrix (RTM)
- Validation Summary Report
- Module 7: Maintenance and Change Management
- Change Control Process
- Security and Access
- Incident Reporting
- Disaster Recovery Planning/ Business Continuity Planning
- Record Retention
- Q&A Session with the Presenter
- Module 8: 21 CFR Part 11, FDA’s Guidance for ER/ES
- 21 CFR Part 11 Guidance Overview
- 21 CFR Part 11 Guidance and Compliance for Electronic Records/Signatures (ER/ES)
- Module 9: Data Integrity and Governance
- Data Integrity
- Data Life Cycle Approach
- Data Governance
- Data Privacy
- Module 10: Software and Services
- Computer Off-the-Shelf (COTS) Software
- Cloud Systems
- Software-as-a-Service (SaaS)
- Module 11: Spreadsheets, Integration and Retirement
- Single-Sign-On (SSO)
- Spreadsheet Validation
- Legacy Systems and Integration
- Data Conversion and Migration
- System Retirement Challenges
- Module 12: Vendor Audit
- Vendor Audit Preparation and Execution
- Vendor Audit Reporting and Follow-Up
- Module 13: FDA Regulatory Compliance Trends and Best Practices
- Current Compliance and Enforcement Trends
- Industry Best Practices
- Q&A Session with the Presenter
Carolyn Troiano
ERP Project Manager, City of Richmond
Carolyn Troiano has more than 40 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco, e-cigarette/e-liquid and other FDA-regulated industries.
During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe, developing validation programs and strategies, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.
