FDA regulated companies in the modern world relies increasingly on computerized systems. Ensuring quality and accuracy of data is paramount to these companies, and thus, Computer System Validation (CSV) is necessary to ensure that critical processes are functioning properly.
The objective of validation is to produce documented evidence that parts of the facility will work correctly every time when brought into use. The goal is also to make sure that quality is built into the system at every step; and not just a factor at the 'output' end of the process chain.
Computer system validation requires, first, that you obtain or design a process that can consistently conform to requirements; and then that you run studies demonstrating that the case. Both tasks can be performed with the aid of the right statistical tools. Without adequate planning and preparation, computer system validation can encounter several problems, eventually leading to the failure of the process.
Help your people gain a fuller understanding of the requirements for computer system validation and explore the methods to comply with them with our FDA Computer System Validation Training pack.
All Modules:
The objective of validation is to produce documented evidence that parts of the facility will work correctly every time when brought into use. The goal is also to make sure that quality is built into the system at every step; and not just a factor at the 'output' end of the process chain.
Computer system validation requires, first, that you obtain or design a process that can consistently conform to requirements; and then that you run studies demonstrating that the case. Both tasks can be performed with the aid of the right statistical tools. Without adequate planning and preparation, computer system validation can encounter several problems, eventually leading to the failure of the process.
Help your people gain a fuller understanding of the requirements for computer system validation and explore the methods to comply with them with our FDA Computer System Validation Training pack.
All Modules:
- Module 1: Computer System Validation: Step-by-Step
- Module 2: Project Management for Computer Systems Validation
- Module 3: Best Practices in Preparation for an FDA Computer System Audit
- Module 4: Developing a Strategic Approach to FDA Compliance for Computer Systems
- Module 5: FDA Modernization and Restructuring of the SDLC for Computer System Validation (CSV) and Compliance
- Module 6: Data Integrity Compliance for Computer Systems Regulated by FDA
- Part 1 : Computer System Validation: Step-by-Step
- Instructor: Dr. Ludwig Huber
Areas Covered in the Webinar:
- US FDA and EU requirements and enforcement practices
- Learning from recent FDA 483s and Warning Letters
- Selecting the right validation model: qualification vs. verification
- Eight fundamental steps for computer system validation
- Structure and example of a validation plan
- Justification and documentation of risk levels
- Examples of qualification document for suppliers of commercial systems
- Examples for requirement and functional specifications
- Example for IQ protocols
- OQ test protocols: development, execution, approval - examples
- Documentation of ongoing performance
- Validation of existing systems
- Structure and example of a validation report
- Step-by-step case studies from laboratories and manufacturing units for easy implementation
- Part 2 : Project Management for Computer Systems Validation
- Instructor: Angela Bazigos
Areas Covered in the Webinar:
- Basics of Project Management
- Basics of Computer Systems Validation
- Project Planning for a Computer Systems Validation Project
- Common Pitfalls and How to Avoid them
- What is FDA's most current thinking related to computers and electronic records?
- What are the inspection trends?
- What are most frequent recent citations for Part11?
- What are the most frequent deviations for computer system validation?
- How important is risk based Part11 compliance?
- Part 3 : Best Practices in Preparation for an FDA Computer System Audit
- Instructor: Carolyn Troiano
Areas Covered in the Webinar:
- Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
- “GxP” - Good Manufacturing, Laboratory and Clinical Practices
- 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
- Data Archival to ensure security, integrity and compliance
- Validation Strategy that will take into account the system risk assessment and system categorization (GAMP V) processes
- Recent FDA findings for companies in regulated industries
- The resources, documentation and room preparation necessary to adequately prepare for inspection
- Q&A
- Part 4 : Developing a Strategic Approach to FDA Compliance for Computer Systems
- Instructor: Carolyn Troiano
Areas Covered in the Webinar:
- System Development Life Cycle (SDLC) Methodology
- Computer System Validation (CSV)
- Good “Variable” Practice (GxP)
- Good Manufacturing Practice (GMP)
- Good Laboratory Practice (GLP)
- GAMP 5 Guidance for System Classification
- Risk Assessment and Management
- Validation Strategy
- Change Control and Audit Trails
- User Requirements Specification (URS) & Functional Requirements Specification (FRS)
- System Design Specification (SDS) and System Configuration Specification (SCS)
- Test Planning, Execution and Documentation (IQ/OQ/PQ)
- Requirements Traceability Matrix (RTM)
- System Acceptance, Release Notification and Deployment
- System Retirement
- Data Governance Archival
- Q&A
- Part 5 : FDA Modernization and Restructuring of the SDLC for Computer System Validation (CSV) and Compliance
- Instructor: Carolyn Troiano
Areas Covered in the Webinar:
- Learn how to identify “GxP” Systems
- Learn about FDA’s current program for modernization of technology, and how this will impact industry
- Learn about FDA’s Technology Modernization Action Plan (TMAP), including what work is underway and what is planned in the near term
- 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
- We will discuss cloud computing and Software as a Service (SaaS) systems that can be embraced and validated effectively
- Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance procedures, including ways to improve efficiency and effectiveness
- Understand how to maintain a system in a validated state through the system’s entire life cycle in a more cost-effective manner
- 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
- 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
- Part 6 : Data Integrity Compliance for Computer Systems Regulated by FDA
- Instructor: Carolyn Troiano
Areas Covered in the Webinar:
- Computer System Validation (CSV)
- System Development Life Cycle (SDLC) Methodology
- Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
- Data Integrity (DI)
- Validation Strategy, Planning and Execution
- System Risk Assessment
- GAMP 5 “V” Model and Software Categorization
- 21 CFR Part 11, FDA’s Guidance on Electronic Records/Electronic Signatures (ER/ES)
- Security, Access, Change Control and Audit Trail
- Criteria required to ensure data is created and maintained with integrity through its life cycle
- Policies and Procedures to support CSV and DI assurance
- Training and Organizational Change Management
- Current FDA Trends in Compliance and Enforcement
- Industry Best Practices and Common Pitfalls
- Q&A
Course Provider
Carolyn Troiano,
