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Data Integrity for the Pharmaceutical Industry

In this course, you will obtain the knowledge and practical application experience needed to ensure your devices and regulated IT systems maintain or exceed the high level of quality expected by FDA. This course specifically focuses on appropriately maintaining electronic records, electronic signatures, and the data integrity of software systems used in the pharmaceutical industry.

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Brief Overview of This Course on Data Integrity for the Pharmaceutical Industry

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Class Content

In-Depth

Class Duration

2 Half-Days*

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person**

Certification of Completion

Yes

Continuing Education Units (CEUs)

0.8

* SkillsLab classes delivered in-person (private or public) are full-day sessions delivered in 1 day. 

** Interested in private training for your team, virtually or in-person at your facility? See more details or ask us about it!

Upcoming Classes

Upcoming Training Classes on Data Integrity for the Pharmaceutical Industry

SkillsLab $1495

SkillsLab $1495

There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!

GROUP DISCOUNT

Save up to

25%

Register 3 people, 4th attends free!

Free

*This offer cannot be combined with any other promotional offer(s).

Course Overview

Here's What We Cover in This Class on Data Integrity for the Pharmaceutical Industry

FDA is changing its approach to regulating software in quality systems. Simply following their guidance has not been enough for the pharma industry to guarantee the high quality of systems that FDA expects. Manufacturers will now be responsible for determining their own controls and justifying their effectiveness to regulators rather than following explicitly prescribed guidance.

Course Overview
SkillsLab Class

Understanding Data Integrity Within a Quality Management System

  • Data-related terms
  • Data integrity
  • Exercise! ALCOA+
  • Regulatory requirements
  • Data integrity governance
  • Exercise! Code of Conduct and Governance Procedure for DI

Automated Systems and Data Integrity

  • US FDA emphasis on computer system controls and data integrity
  • Case Study! Data Integrity and Third-Party-Testing Labs
  • Application of the management of risk
 

Implementation and Applications

  • Evaluating and controlling data
  • Exercise! Evaluating Raw Data
  • Implementing other controls
  • Exercise! Evaluating a System and Process
  • Exercise! Assessing Systems
  • Audits and Inspections
 

Preparing for Regulatory Review

  • Rationale for electronic records in regulatory submissions
  • Part 11 enforcement
  • Management and risk-based control of Part 11-compliant systems
  • Real-world application
  • Case Study! Intentional Falsification of Calibration Data
  • Case Study! Invalidating Results Without Justification
  • Case Study! Unauthorized Access to Critical Systems
What You Will Learn

What You Will Learn

At the conclusion of this training class, you will be able to
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Identify key principles and best practices of data integrity governance

Identify the regulatory requirements for current Good Manufacturing Practices (cGMP) related to data integrity in the European Union (EU) and United States (US) for pharmaceuticals

Describe US regulatory expectactions and guidance for data integrity as well as the identification and management of risk related to data integrity, and analyze data integrity breaches for regulatory issues and potential solutions

Who Should Attend

Who Should Attend

Anyone in a pharma organization responsible for managing procedures, approvals, and data in electronic form. All RA/QA professionals and other cross-functional team members.

  • Regulatory Affairs (RA) Managers
  • Quality Control (QC) Personnel
  • Data Managers
  • RA/QA Professionals
  • Cross-Functional Team Members
Related Courses & Services

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