We can begin using some of the CSA principles today, even outside of the intended focus for the final guidance. This is provided that for these other areas, we are able to adequately explain their use and defend the tie-in to Part 11, data integrity, the Quality Management System (QMS) and other relevant documents and programs.
In this seminar, we’ll provide an overview of the transition process in going from CSV to CSA. We’ll then dive into a step-by-step guide for the transition that can be done by any company. The transition steps, related documents and other artifacts, and the potential issues to watch out for will be laid out very carefully.
The seminar will include a Q&A session at the end of each day. There are Appendices at the end of the slide deck that provides references related to the content that can be reviewed at your leisure. There is also a series of questions with answers provided, along with a rationale for the correct choice. Again, this can be reviewed after the event to further support the learnings from this seminar.
Agenda
Day 01Morning Session:
- Computer System Validation (CSV)
- GAMP®5 “V” Model
- System Development Life Cycle (SDLC) methodology
- Validation Planning
- 15-Minute Break
- Validation Requirements
- Validation Testing
- Validation Reporting
- Requirements Traceability Matrix (RTM)
- 1-Hour Lunch Break
- Computer Software Assurance (CSA)
- Critical Thinking
- GAMP®5, 2nd Edition and its alignment with CSA
- Transition from CSV to CSA
- 15-Minute Break
- 21 CFR Part 11 Guidance (ER/ES)
- 21 CFR Part 11 Requirements and Controls
- Common 21 CFR Part 11 Deficiencies
- 15-Minute Q&A
Morning Session:
- Data Integrity Guidance (ALCOA+++ Principles)
- Data Integrity Requirements and Controls
- Common Data Integrity Deficiencies
- Data Life Cycle Management
- Data Governance
- 15-Minute Break
- Data Privacy
- Commercial-Off-the-Shelf (COTS) solutions
- Cloud Services
- Software-as-a-Service (SaaS) Solutions
- Platform-as-a-Service (PaaS) Solutions
- Infrastructure-as-a-Service (IaaS) Solutions
- Single-Sign-On (SSO)
- Vendor Audit
- 1-Hour Lunch Break
- Artificial Intelligence (AI)
- Machine Learning (ML)
- Large Language Models (LLMs), including ChatGPT
- Retrieval-Augmented Generation (RAG)
- Recursive Language Models (RLMs)
- 15-Minute Break
- FDA Regulatory Compliance
- Current FDA Regulatory Enforcement Trends
- FDA Inspection Types
- Internal Audit
- Industry Best Practices
- 15-Minute Q&A
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
Location
ADDRESS
Richmond, VA
United States
Venue to be announced shortly.
