21 CFR 11 WITH XOOLI
21 CFR 11 Compliance for Excel Spreadsheets for FDA Regulated Companies
from Morf Media, USA
Now on Mobile Devices
In recent years regulations regarding Excel spreadsheets have dramatically increased. Lack of compliance with 21 CFR Part 11 may result in a serious actions against your company from the FDA. However, Microsoft Excel is not comprehensively designed for use within regulated environments.
WHAT YOU WILL LEARN
This course provides you with comprehensive information on how to be compliant within Excel. It delivers full training in every relavant area of spreadsheet regulations and how best to implement each one into the daily procedures of your company.
BASIC & INTERMEDIATE
- Full overview of the requirements for Excel spreadsheets
- Comprehensive FDA Part 11 Validation Guidance
- An outline of compliance problems with spreadsheets
- Complete design specifications for 21 CFR 11 compliance
- How to follow exact documentation guidelines for Part 11
- A look at the future trends in 21 CFR 11 compliance for Excel spreadsheets
- Quality Managers
- Quality Engineers
- Small business owners
- GxP Personnel
- Quality VPs
- IT VPs
“Our quality managers enjoyed using XOOLI and I appreciated how time and resource effective it is to offer mobile training to my staff.”
Comprehensive 21 CFR Part 11 regulation training provides insight, improves documentation processes, and reduces negative agency actions.
Delivers expert training in how to follow exact guidelines to produce compliant Excel spreadsheets.
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.
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.