All About Data Integrity by Design

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A pharmaceutical company touts the safety of its new wonder drug. But when the FDA inspects the offshore production facility, work is halted immediately; important quality control data is missing. Unfortunately, this real-life example of compromised data integrity isn’t uncommon. Problems with the accuracy of data and consistency of data exist across all industries and can cause everything from minor hassles to significant business problems.

Data integrity is critical to regulatory compliance, and the fundamental reason for 21 CFR Part 11 published by the U.S. Food and Drug Administration (FDA). FDA published the first guideline in 1963, and since then FDA and European Union (EU) have published numerous guidelines on various topics related to data integrity for the pharmaceutical industry. Regulators wanted to make certain that industry capture accurate data during the drug development lifecycle and through commercialization-consider the number of warning letters issued lately by inspectors across the globe on data integrity.

In this era of big data, when more pieces of information are processed and stored than ever, data health has become a pressing issue — and implementing measures that preserve the integrity of the data that’s collected is increasingly important. Understanding the fundamentals of data integrity and how it works is the first step in keeping data safe. Learn what data integrity is, why it’s essential, and what you can do to keep your data healthy.

Our Training Approach:

Our experienced Data integrity and Computerized system validation experts have designed a concise, yet thorough course to equip you with the information you need to ensure your data is kept preserved in the right manner. There will be plenty of opportunities to get answers to your company-specific questions.

What You Get:

An update on hot topics around Data Integrity in the pharma world. These topics are addressed in the following modules:

  1. ALCOA+: What is data ALCOA and how is it used in practice?
  2. Roles and responsibilities of Data Integrity
  3. Data Integrity Governance Model: How to use it?
  4. Digital signatures: Pros and cons/options and challenges

This course will help you to set up an approach for Data governance framework that creates awareness of what it really takes to ensure your data is meeting the Data Integrity requirements of 21 CFR Part 11 and Annex 11 regulations.

Who Should Attend Data Integrity Training?

IT, QA, Engineering & Business Managers and Professionals who need to:

  • Manage their Data management domain and guard the Data Integrity of the information running through their computerized systems and processes
  • Approve IT system project deliverables, such as validation plans, requirements documents, validation protocols (IQ, OQ, PQ), trace matrices, and validation reports
  • Design data flow diagrams/ models and apply Data Integrity controls
  • Execute internal audits on Data Integrity processes and related documents
  • Assess software vendors’ quality assurance practices prior to purchasing systems for use in GxP activities

Materials Provided:
Student reference materials, Certificate of Completion

Course Number: CS 250

Duration: 8 hours

Cost: $800 per student

Group Pricing: Enroll two students at full price and receive a third seat FREE.

We Are Offering This Course on the Following Dates:

 

Private Session: We can bring this course to you. Save travel costs and select the dates that work for your team. Private classes start at $3,500 for up to twelve (12) students – that’s 63% off the full price. Contact Us for larger group pricing, additional questions, or to schedule your session.