In recent years regulations regarding Excel spread-sheets have dramatically increased. Lack of compli-

ance 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 LE ARN

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.

ARE AS COVERED

• 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

LE VEL

Basic & Intermediate

PERFECT CANDIDATES

• Quality Managers• Quality Engineers• Small business owners• GxP Personnel• Consultants• Quality VPs• IT VPs

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.

Utilizes an easy, fast and engaging approach to learning using challenges, game theory and social feedback capabilities.

TR AINING FROM INDUSTRY E XPERTS

Ms. Angela Bazigos Chief Compliance Officer and Head of Life Sciences and Healthcare at Morf Media, USA

Honored by Stanford Who’s Who for contributions to the Life Sciences Industry, Ms. Bazigos has more than 40 years of experience working with pharma, biotech, medical device, food safety, and

healthcare organizations around the world. She is a Past President of PRCSQA, and is a frequent contributor to industry publications both inter- national and domestic. She co-authored Computerized Systems in Clinical Research/Current Date Quality and Data Integrity Concepts with the FDA and holds a patent in Software Compliance. 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 Ge- nomics, and held executive roles at Incyte Genomics, Roche and Counsyl among others.

Morf Playbook™ Presents

21 CFR 11 Compliance for Excel Spreadsheets for FDA Regulated Companies from Morf Media, USA

NOW ON MOBILE DEVICES

morfmedia.com About Morf Playbook™ Morf Playbook is a mobile and social talent development platform that provides compliance training. For more information about Morf Playbook and Morf Media, USA visit MorfMedia.com.

1