21 CFR 11 WITH XOOLI
Project Management for Computer Systems Validation from Morf Media, USA
Now on Mobile Devices
Computer Systems Validation mandates a very specific set of tasks that are often mismanaged. This results in missed deadlines, increased costs and regulatory risk, and failed market launches for company products.
20% of product recalls in the medical device industry are due to faulty software, per the CDRH. These issues can be effectively averted with proper computerized systems validation and 21 CFR 11 compliance.
WHAT YOU WILL LEARN
This class will teach you the basic tenets of project management, the basic tenets of 21 CFR 11 compliance for Computer Systems Validation, and will show you how to deliver projects on time and on budget, all while meeting regulatory compliance requirements.
BASIC & INTERMEDIATE
- A comprehensive overview of the basics of Project Management
- Complete training in the basics of Computer Systems Validation
- How to implement effective project planning for a Computer Systems Validation project
- A primer on the common pitfalls of management on computerized systems and how to avoid them
- IT Management
- Business Process Owners
- Quality Managers
- Quality Engineers
- GxP Personnel
“Our quality managers enjoyed using XOOLI and I appreciated how time and resource effective it is to offer mobile training to my staff.”
Comprehensive training in Computer Systems Validation provides clarity, improves management processes, and reduces negative project outcomes.
Delivers expert training in how to effectively implement proper project management in the use of computerized systems.
Clear, step-by-step guidance helps ensure strategy for delivering high-quality products at a profit with consistent operation of all systems.
Provides skill-building and leadership training for regulated industry professionals with RAPS credit — available now on Mobile Devices.
Utilizes an easy, fast and engaging approach to learning using challenges, game theory and social feedback capabilities.
XOOLI is the World’s Easiest to Use Mobile & Social Enterprise Talent Development Platform
Course Author Bio
Ms. Angela Bazigos
Chief Compliance Officer and Head of Life Sciences
Honored by Stanford Who’s Who for contributions to the Life Sciences Industry, Angela has more than 40 years of experience working with life sciences and healthcare organizations around the world. She is a Past President of PRCSQA, a member of the SQA, CVIC, ASQ, DIA and RAPS. She co-authored Computerized Systems in Clinical Research/Current Data Quality and Data Integrity Concepts with FDA and is a frequent contributor to international and industry publications. Ms. Bazigos was recently quoted in the Wall Street Journal on Using Training to Bring Compliance to the Boardroom. Ms. Bazigos additionally served as CCO for Prime Genomics, and held executive roles at Incyte Genomics, Roche and Counsyl among others.