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Data Integrity in a GMP Environment

COURSE TOPIC:

Data Integrity in a GMP Environment

Self-Paced Online Training with Personalized 1-on-1 Trainer Coaching Ensure Compliance and Product Quality with Expert Data Integrity Training Data Integrity is a cornerstone of Good Manufacturing Practice (GMP), critical for maintaining accuracy, reliability, and consistency of data throughout the pharmaceutical product lifecycle. This training equips pharmaceutical and biotechnology professionals with the knowledge to meet regulatory expectations and uphold data integrity standards. Course Overview

  • Duration: 25 minutes (self-paced) + 30 minutes (individual coaching)
  • Language: English
  • Certificate: issued upon successful completion

  What You Will Learn This training provides an overview of Data Integrity. Learning Objectives

  • Understand the ALCOA+ framework and its application in GMP environments
  • Gain insight into key regulatory guidelines and industry standards
  • Learn about data lifecycle management and governance, risk assessments and mitigation strategies
  • Get an overview of data integrity controls 
  • Promote a culture of data integrity
  • Ensure data and supporting systems maintain product quality and regulatory compliance

  Personalized Trainer Support Your enrollment includes 30 minutes of 1-on-1 time with a trainer to ask questions or work through exercises.

  • This session is scheduled at a mutually agreed time within 30 days of purchase.
  • You may reschedule once if done at least 24 hours in advance; otherwise, the session will be forfeited.
  • After enrollment, you will receive an email with instructions to schedule your session.

  Who Should Attend? This training is designed for pharmaceutical and biotechnology personnel involved in GMP-regulated environments seeking to enhance their understanding of data integrity principles and compliance. Ready to Enroll? Secure your spot now for just $100 USD and gain immediate access to the course. Please contact us at info@farbridgepharma.com for customized group training options.

What I will learn?

  • Introduction to Data Integrity
  • Regulatory Requirements (FDA, EMA, MHRA, WHO, PIC/S, ISPE)
  • Data Lifecycle Management and Governance
  • Data Risk Assessment and Mitigation Strategies
  • Data Integrity Controls and Technologies
  • Conclusion and Quiz

Course Curriculum

Data Integrity

  • Introduction: Data Integrity
    02:49
  • Module 1
    00:00
  • Module 2
    00:00
  • Module 3
    00:00
  • Module 4
    00:00
  • Module 5
    00:00
  • Conclusion
    00:00
  • Ensuring Data Integrity Training

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$100.00
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