Data Integrity Principles for FDA Compliance: How to reduce Data Integrity Risk

*Curso a Distancia (Online) - Ya Disponible

(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 course.

BENEFITS

• KNOW How can Data Integrity Risks be Minimized
• KNOW What Controls could be in place reducing the risk for Non Compliance
• Know Common errors to avoid them

OBJECTIVES

• 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, Systems vs. Computerized System,
• 21 CFR Part 11 Regulation vs. Data Integrity
• Data Governance-Define responsibilities
• FDA Top Data Integrity Issues found During Inspection
• 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

OFERTA ESPECIAL - 

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