|
3-Hour Virtual Seminar on Risk Based Approach to IT Infrastructure Qualification, Compliance & Control
Wednesday, December 27, 2023
DUBLIN, Dec. 19, 2023 /PRNewswire/ -- The "3-Hour Virtual Seminar on Risk Based Approach to IT Infrastructure Qualification, Compliance & Control" webinar has been added to ResearchAndMarkets.com's offering.
https://mma.prnewswire.com/media/539438/Research_and_Markets_Logo.jpg
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 video files, amongst others, must be managed and maintained with integrity throughout their entire life cycle.
The webinar will explore the best practices and strategic approach for evaluating computer systems used in the conduct 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 will also discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately.
It will cover the approach for validating/qualifying infrastructure components to FDA-regulated systems, including cloud-based servers and Software-as-a-Service (SaaS) solutions. A different approach is required for auditing and performing Installation Qualification (IQ) for systems supported by these vendors.
The webinar will also walk through the entire set of essential policies and procedures, as well as other supporting documentation and activities that must be developed and followed to ensure compliance. It will provide an overview of practices to prepare for an FDA inspection, and will also touch on the importance of auditing vendors of computer system hardware, software, tools and utilities, and services.
Finally, the webinar 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.
Who Should Attend:
This webinar is intended for those involved in planning, execution and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.). Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, sample labeling, adverse events management and post-marketing surveillance.
This webinar will also benefit any vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.
For more information about this webinar visit https://www.researchandmarkets.com/r/razcbk
About ResearchAndMarkets.com
ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
Media Contact:
Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call +1-917-300-0470
For U.S./CAN Toll Free Call +1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1904
Fax (outside U.S.): +353-1-481-1716
Logo: https://mma.prnewswire.com/media/539438/Research_and_Markets_Logo.jpg
View original content:https://www.prnewswire.com/news-releases/3-hour-virtual-seminar-on-risk-based-approach-to-it-infrastructure-qualification-compliance--control-302018915.html
SOURCE Research and Markets
|
|
|
|
|
|
 |
Energy Toolbase Launches Energy Storage Partnership with Sungrow to Support PowerStack 255CS and PowerTitan 2.0 | Jan 22, 2026
|
|
RS now offers Phoenix Contact's pioneering new NearFi technology | Jan 22, 2026
|
|
SCAILIUM Debuts "AI Production Layer" to Overcome GPU Starvation and Slash AI Energy Waste | Jan 22, 2026
|
|
Einride and IonQ Partnership Uses Quantum Computing to Optimize the Logistics of Electric and Autonomous Freight | Jan 22, 2026
|
|
MetaOptics to Showcase Five Breakthrough Metalens-Powered Products at CES 2026 | Jan 22, 2026
|
|
Quantum Art Raises $100 Million in Series A Round to Drive Scalable, Multi-Core Quantum Computing | Jan 22, 2026
|
|
No Assembly Required: Barrett Distribution Centers Powers Maxwood Furniture's West Coast DTC Expansion | Jan 22, 2026
|
|
Hesai Recognized as the Only Lidar Company on Morgan Stanley's "Humanoid Tech 25" of Global Robotics Leaders | Jan 22, 2026
|
|
Fresco Raises EUR15m Series C to Power the Future of AI-Driven Cooking and the Connected Kitchen Ecosystem | Jan 22, 2026
|
|
Cellid and Jig.jp Jointly Develop AR Glasses | Jan 22, 2026
|
|
|
|
