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Advanced Auditing Strategies to Detect and Mitigate Data Integrity Risks

This course equips organizations to conduct targeted data integrity audits, strengthen records governance, and identify enforcement gaps before they create compliance or e-discovery exposure. It supports more consistent oversight across systems, documentation, and record management practices. This Course is designed for professionals responsible for records oversight, compliance controls, documentation practices, and data governance activities.

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US $190 per learner

30-Days Unlimited Streaming Access

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REGISTER FOR THE COURSE

To Get 30-Day Access to ONLY this Course 

US $190 per learner
  • This course is Included in Subscription Pack
Subscription include access to entire Learning Library
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  • Instructor : Joy Mcelroy
  • Study time : 90 Minutes
  • Skill Level: Intermediate
  • Course ID: TF3052
  • Assessment & Certification Included
  • Ask the Expert

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About the Course

Reliable data integrity controls depend on a clear understanding of how records are created, classified, managed, and enforced across an organization. Inconsistent tagging practices, disconnected systems, and uneven policy application can increase compliance exposure and weaken oversight during inspections, audits, and e-discovery activities. Establishing a measurable baseline is essential for evaluating whether current controls are functioning consistently across documentation, processes, and computerized systems used throughout regulated operations. Poor coordination between departments can also limit visibility into record handling practices.

This course focuses on practical auditing approaches used to assess records management structures, data governance practices, and live computer system controls. It addresses methods for identifying parallel record-keeping, evaluating data life cycle processes, and improving consistency in policy enforcement. Current FDA and EU enforcement trends are also examined to help organizations recognize areas receiving increased regulatory attention and strengthen internal accountability before deficiencies become broader operational or compliance concerns.

  • Strengthen Audit Visibility Across Records and Systems:

    Organizations often struggle to verify whether records are consistently classified, controlled, and retained across multiple systems. This course provides practical methods for establishing audit baselines, reviewing live computerized environments, and identifying weaknesses in policy enforcement. These capabilities support stronger internal oversight and reduce the likelihood of unmanaged data practices remaining undetected during inspections or internal reviews.

  • Improve Governance Decisions Under Regulatory Scrutiny:

    Regulatory expectations surrounding data governance and record integrity continue to receive scrutiny from FDA and EU authorities. Participants gain a structured approach for evaluating governance programs, recognizing indicators of parallel record-keeping, and assessing data life cycle controls. The course also strengthens decision-making when addressing compliance gaps, documentation inconsistencies, and e-discovery risks across operational functions.

Key Areas Covered

  • Establishing baseline assessments for records management and data integrity auditing
  • Applying consistent metadata tagging and standardized policy controls across records and documents
  • Inspecting live computerized systems to assess data integrity control effectiveness
  • Identifying pattern recognition indicators and flags associated with parallel record-keeping
  • Evaluating data governance programs, process mapping activities, and data life cycle assessments
  • Improving management centralization and reducing disconnected record management practices across departments
  • Reviewing FDA and EU enforcement trends related to data integrity citations and compliance expectations
  • Reducing compliance exposure and e-discovery risk through stronger records oversight practices

Who Must Attend

  • Senior Quality Managers
  • Regulatory Professionals
  • Compliance Professionals
  • Validation Engineers
  • Quality Auditors
  • Document Control Specialists

Quality training, expert insights, and answers that matter. Know your Expert

JOY MCELROY

Joy McElroy brings more than 25 years of pharmaceutical and biotech industry experience focused on Quality Assurance, GMP compliance auditing, validation, technical writing, and computerized system compliance. Her background includes batch record reviews, GMP training, equipment qualification, cleaning validation, and Part 11 compliance work for multiple pharmaceutical manufacturers. Through consulting and training engagements, she has supported organizations in strengthening audit readiness, documentation practices, and compliance controls connected to data integrity and records management.

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Ready to Strengthen Your Team? Let’s Build Your Training Plan.

Whether you’re looking for a single onsite workshop or a multi-team training series, we’ll help you design a program that fits your goals, timelines, and operational reality.

Your team deserves the clarity.
Your organization deserves the confidence.

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Our students love us ❤️

“Clear explanations on identifying weak points in records management and data integrity controls. Very relevant to current compliance expectations.”

Senior Quality Manager

“Practical examples around audit preparation and governance reviews made the session immediately applicable to our operations.”

Validation Engineer

“The content was practical, well-structured, and directly applicable to improving internal audit processes.”

Quality Auditor

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