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, images, audio and v...
We will explore the best practices and strategic approach for evaluating computer systems used in the conduct of 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 also discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately.
We will cover the approach for validating/qualifying infrastructure components to FDA-regulated systems, including cloud-based servers and SaaS solutions. A different approach is required for auditing and performing Installation Qualification (IQ) for systems supported by these vendors.
We will also walk through essential policies and procedures, supporting documentation, and activities that ensure compliance. We will provide an overview of FDA inspection prep and vendor audit best practices.
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.
We will explore the best practices and strategic approach for evaluating computer systems used in the conduct of 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 also discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately.
We will cover the approach for validating/qualifying infrastructure components to FDA-regulated systems, including cloud-based servers and SaaS solutions. A different approach is required for auditing and performing Installation Qualification (IQ) for systems supported by these vendors.
We will also walk through essential policies and procedures, supporting documentation, and activities that ensure compliance. We will provide an overview of FDA inspection prep and vendor audit best practices.
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.
Course Content
- Identify “GxP†Systems
- CSV approach based on FDA requirements
- Computer Software Assurance (CSA) concepts
- Cloud and SaaS validation and IQ practices
- SDLC framework for risk-based validation
- Validation documentation best practices
- Maintaining validated state through lifecycle
- Data integrity assurance in GxP activities
- Compliant GxP documentation strategies
- Key policies/procedures for system validation
- 21 CFR Part 11 electronic records/signature controls
- Regulatory influences on FDA expectations
- Performing computer system risk assessments
- Validation rationale using size, complexity, risk
- Audit prep for FDA inspections
- Vendor audit execution and documentation
- Best practices for maintaining compliance & data integrity
Speaker
Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.
Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.
Who Should Attend
- 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
- 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
- Life sciences vendors and consultants involved in validation & compliance
