Online Webinar 2019 - 2019 Computer System Validation (CSV) Training Program

Session Highlights
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
Why should you attend?
This session will provide some insight into current trends in compliance and enforcement that can help in preparation for an FDA inspection or audit of computer systems that are regulated. There are some key areas of focus that will be covered that will help you to plan for an on-site inspection.
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit. It will also take into account areas where FDA will likely focus their effort, including on the higher-risk systems.
Part 2 : Applying Computer System Validation (CSV) to Mobile Applications
Live, Interactive Training Webinar : Tue, November 12, 2019 at Time: 1:00 PM – 2:30 PM EST
Session Highlights
• Gain an understanding of how mobile applications should be handled when performing validation work
• Understand the best practices for maintaining a mobile application in a validated state
• Discuss the best practices necessary to ensure all systems, including mobile applications, are validated appropriately
• Learn how to develop the appropriate computer validation strategy when dealing with mobile applications to ensure a good balance of cost vs. risk
• Understand how to effectively document the process of computer system validation, and maintain current information about the various systems in your organization, as they begin to include mobile applications
• Learn how to gain information about trends in validation of mobile applications, as industry progresses and new best practices emerge
• Understand some of the key “pitfalls” to avoid when applying the concepts of computer system validation to mobile applications
• Q&A
Why should you attend
You should attend this seminar if you are responsible for planning, executing or managing the implementation of any mobile application that is part of a system governed by FDA regulations, or if you are maintaining or supporting such a system
We will discuss in detail how computer system validation can be applied to mobile applications subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.
This comprehensive 2-Part live training program includes the following for each registered attendee:
A copy of the presentation slides
A certificate of participation for attendee training records
Professionals in the following industries may also benefit from the content:
Pharmaceutical
Medical Diagnostics
Biotechnology
Tobacco and Related (Vapor, e-Cigarette, Cigar, etc.)
Any other FDA-regulated industry, plus any Life Science Consulting or Contracting firm
Who should attend?
Information Technology Analysts
Information Technology Developers and Testers
QC/QA Managers and Analysts
Clinical Data Managers and Scientists
Analytical Chemists
Information Technology Analysts
Clinical Data Managers, Scientists
Analytical Chemists
Compliance Managers
Laboratory Managers
Automation Analysts
Manufacturing Managers, Supervisors
Supply Chain Specialists
Computer System Validation Specialists
GMP Training Specialists & Data “Owners” & Data “Stewards”
Speaker
Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.
During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA's electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.
Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI's Educational Fund as a project management instructor for non-profit organizations.