21 CFR Part 11 Basic Concepts for FDA Regulated Companies

21 CFR 11 WITH PHONIZE

21 CFR Part 11 Basic Concepts for FDA Regulated Companies from PHONIZE, USA
Now on Mobile Devices

21 CFR 11 WITH PHONIZE

21 CFR Part 11 Basic Concepts for FDA Regulated Companies from PHONIZE, USA
Now on Mobile Devices

Continuous technological innovation and computer­ized systems provides inherent security and regula­tion concerns within the industry. This presenta­tion provides an overview of and an historical perspective on the Part 11 regulation, including general, electronic records, and electronic signa­ture requirements.

WHAT YOU WILL LEARN

This comprehensive course provides clear guidance to project managers, IT managers and quality assurance personnel on how to formulate and deliver best practices in regards to Part 11 to their individual teams.

AVAILABLE LEVELS
BASIC & INTERMEDIATE

TOPICS COVERED

  • A comprehensive history and detailed overview of 21 CFR Part 11
  • Specifics on Subpart A: General Provisions
  • Specifics on Subpart B: Electronic Records
  • Specifics on Subpart C: Electronic Signatures
  • Complete scope of regulations and their direct applications
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PERFECT FOR

  • Project/Strategic Management
  • Quality Assurance staff
  • IT staff
  • Operations staff
“Our quality managers enjoyed using PHONIZE and I appreciated how time and resource effective it is to offer mobile training to my staff.”
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Critical, regulated training provides compliance, improves processes, reduces negative reviews, and improves work consistency.

Provides a clear approach to understanding the history and reasoning behind electronic records and software regulation for project management personnel, IT staff, operations staff and quality assurance personnel.

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.

PHONIZE is the World’s Easiest to Use Mobile & Social Enterprise Talent Development Platform 

PHONIZE is the World’s Easiest to Use Mobile & Social Enterprise Talent Development Platform