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Data integrity is not only an electronic-records or laboratory issue. It is a core GMP responsibility that affects the reliability of the evidence used to release product, investigate deviations, support regulatory decisions, and demonstrate that a pharmaceutical quality system is operating as intended.
The source program provides a practical review of FDA, MHRA, WHO, PIC/S and European data integrity expectations, with particular attention to how organizations detect failures, investigate root causes, distinguish intentional from unintentional problems, apply Quality Risk Management, develop remediation plans, and integrate FDA and MHRA approaches into a workable compliance program.
For Compliance Officers, Quality leaders, internal auditors and senior management, the central question is not simply whether the company has a data integrity SOP. The more important question is whether actual laboratory, manufacturing and computerized-system practices generate complete and reliable data - and whether Quality oversight can identify problems before an investigator does.
The session is especially relevant where organizations rely on electronic laboratory systems, audit trails, manual transcription, raw-data review, outsourced testing, global supply chains, or multiple functions that create and review GMP records. Weak controls in any of these areas can undermine confidence in the wider quality system.
Attendees will examine how to identify tell-tale signs of data integrity problems, use risk-based methods to focus attention on vulnerable operations, investigate failures in a structured way, and design remediation that reduces risk to an acceptable level rather than treating each event as an isolated documentation mistake.
The practical objective is to help organizations move from reactive data-integrity remediation toward a defensible governance model in which responsibilities, system controls, review practices, escalation pathways, and management oversight are clear before an inspection or major quality event occurs.
Important Current Update - 2026 FDA Enforcement Signal
FDA enforcement activity in 2026 reinforces that data integrity remains an active inspection and quality-system priority. Recent Warning Letters show FDA focusing not only on missing records, but also on audit-trail review, unreported testing, backdated or manipulated documentation, destruction of records, and whether the Quality Unit has the authority, resources and systems to detect and prevent these failures.
June 2026 - Huons Co., Ltd.: FDA described critical data-integrity breaches involving discarded microbiology evidence, undocumented failures and manipulated camera timestamps, and requested a comprehensive investigation into the scope and root causes of inaccurate or inconsistent data. July 2026 - Shimoga Chemicals: FDA cited unreported HPLC injections and inadequate electronic-data review; the agency noted that the Quality Unit did not review the electronic data before product release. July 2026 - Dabur India Limited: FDA criticized falsified records and inadequate oversight, and specifically rejected a response that treated the failures as isolated procedural gaps rather than evidence of broader Quality Unit and quality-culture weaknesses. July 2026 - BioMylz Pvt. Ltd.: FDA cited destruction of production and laboratory records, failure to retain original data, and persistent weaknesses in data controls.
These enforcement examples are added as a current 2026 market-relevance update. They should not be represented as specific case studies taught in the webinar unless the instructor confirms they are included in the September 28 presentation.
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