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How to reduce Data Integrity Risk (Espanol)

*Curso a Distancia (Online)

(For bio-pharmaceutical, medical devices and regulatory Industries, including Services Industries)

Data Integrity for GMP records refers to the completeness, consistency and accuracy of data. Complete, consistent, and accurate data should be “Attributable”,“Legible”,Contemporaneously”, recorded, “Original” or a true copy, and “Accurate” (ALCOA). Such data to be acceptable for this purpose must be reliable and accurate over its entire lifecycle. Data Integrity has been the common issue that is found during FDA inspections.

These data integrity-related cGMP violations have led to numerous regulatory actions, including warning letters, import ,alerts and consent decrees. When FDA finds any invalid or unreliable data during the inspection, it is considered by the FDA that the product is adulterated as per 21 CFR part 210/211, part 820. GMP data is the evidence for assuring that the products are produced as per GMP regulations. Such ALCOA is the acronym that resumes the expectations of FDA’s about GMP records to be acceptable with GMP regulations. But how to meet these Data Integrity expectations? How to meet FDA regulations. How can data Integrity risks be minimized, What controls could be in place to meet Data Integrity requirements? These are the main topics to be discussed on this certification program


•Know what Data Integrity is, and be able to detect Data Integrity Issues in advance,

•KNOW How can Data Integrity Risks be Minimized

•KNOW What Controls could be in place to reduce the risk for Non-Compliance

•Know Common errors to avoid them

 Know the impact of Non-Compliance, how to be Minimized


Section I: Data Integrity: An Introduction to Applicable Principles

(not limited to:)

•Why Data Integrity Guideline (Defining ALCOA), (GMP Regulations)

General Definitions and Terminology:

•What is Data, Raw Data, Meta Data, Data Integrity, Data Lifecycle, other.

•Static and Dynamic Records, Audit Trail, Paper Systems vs. Computerized System,

•21 CFR Part 11 Regulation/Requirements vs. Data Integrity: Computer Validation, Audit Trail, User Access, User Levels, other.

Section II-Data Integrity: Knowing and Applying Risk Assessment Methodology

Objectives: (not limited to)

•How can data Integrity risks be minimized, What controls could be in place to meet Data Integrity requirements

•How to prevent and detect data integrity issues

•Knowing and Applying Risk Assessment Methodology

•Overall Data Integrity Approach

•Business Process Mapping

•Data and System Categorization-Identifying paper and electronic records, defining GxP data elements

 Data Severity Assessment: high/medium/low, System Categorization: Defining GMP documentation Classification

 -  System Categorization Requirements

-System Assessment

•Risk Assessment, Risk Management

•Process Risk Assessment Examples and Discussion: Case Scenario


Section III Data Integrity: Impact of Non-Compliance (not limited to)

FDA Top Data Integrity Issues found During Inspection

•What to do: Data Governance-Defining Responsibilities

•FDA, GMP regulations for FDA compliance

Nota: Programa en Espanol

Disponible: enviar email a :, Modalidad: Online , A distancia


Favor completar hoja de registro (1 hoja por participante)

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IMPORTANTE!!! Luego de realizar el pago, debe llenar registro de matricula

Para otros métodos de pago, llame al (787) 642-9041. 

Nota * Política de Reembolso: no hay reembolso de dinero una vez efectuado el pago, TODA VENTA ES FINAL.   Los cursos/certificaciones no garantizan la obtención de un empleo. Substituciones son aplicables en cualquier momento, con previa coordinación y autorización.

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