RAPS: This course has been pre-approved by RAPS as eligible for up to 4.0 credits towards a participant's RAC recertification upon full completion.
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
They will understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to FDA. The attendees will have a good grasp of how to identify potential weaknesses and findings, as well as how to make recommendations for addressing and remediating them through risk mitigation.
In particular, we will focus on best practices for validating computer systems regulated by FDA and meeting compliance with electronic records and electronic signatures (21 CFR Part 11). We will also provide current FDA trends, including a focus on data integrity issues in industry, which will be illustrated through industry examples.
The seminar will cover what you need to do to prepare for an FDA audit, and also the importance and steps required to be certain you have audited all vendors of regulated systems appropriately.
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.
They will understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to FDA. The attendees will have a good grasp of how to identify potential weaknesses and findings, as well as how to make recommendations for addressing and remediating them through risk mitigation.
In particular, we will focus on best practices for validating computer systems regulated by FDA and meeting compliance with electronic records and electronic signatures (21 CFR Part 11). We will also provide current FDA trends, including a focus on data integrity issues in industry, which will be illustrated through industry examples.
The seminar will cover what you need to do to prepare for an FDA audit, and also the importance and steps required to be certain you have audited all vendors of regulated systems appropriately.
Course Content
Session 1: Introduction to FDA CSV Compliance- Overview of Computer System Validation (CSV)
- Regulatory requirements: FDA 21 CFR Part 11, GAMP 5, and Data Integrity
- Importance of CSV in regulated industries
- Key FDA expectations for CSV compliance
- Analysis of recent FDA warning letters and 483 observations
- Common compliance pitfalls and how to avoid them
- Understanding risk-based validation strategies
- Best practices for applying risk assessment methodologies
- Leveraging CSA (Computer Software Assurance) principles for compliance efficiency
- Ensuring compliance with ALCOA+ principles
- How to prepare for FDA audits and inspections
- Strategies for maintaining validation documentation and traceability
- Impact of AI, cloud computing, and automation on CSV
- Validation strategies for Software as a Service (SaaS) and cloud-based systems
- Addressing cybersecurity and data privacy concerns in CSV
- Real-world case studies on successful CSV implementation
- Industry best practices for maintaining continuous compliance
- Interactive Q&A and expert discussion on FDA trends
Course Provider
Carolyn Troiano,
Who Should Attend
This training is designed for professionals in FDA-regulated industries, including pharmaceuticals, biotechnology, medical devices, and healthcare. It is ideal for:- Quality Assurance (QA) & Compliance Professionals - Ensuring adherence to FDA regulations and industry best practices.
- Regulatory Affairs Specialists - Staying up to date with evolving FDA enforcement trends and expectations.
- IT & Software Validation Teams - Implementing effective CSV strategies for computerized systems.
- GxP System Owners & Administrators - Managing compliance for validated systems in pharmaceutical and medical device environments.
- Auditors & Inspectors - Understanding common FDA findings and preparing for inspections.
- Manufacturing & Operations Managers - Ensuring compliance in automated manufacturing and data-driven environments.
- R&D and Clinical Teams - Maintaining compliance in electronic record-keeping and software validation.
