Good Data Integrity Compliant Practices




What you'll learn
Knowing different aspects of data integrity and also how to identify the data integrity related non confomities.
Improve the working skills because data integrity training expectations are specific.
The learners will develop compliance approach with practical implementation approach.
Overall help to grow in pharmaceutical career by protecting the organisations from identified and potential non conformities.
Requirements
The person should be full focussed during the session.
Description
Data integrity is the degree to which data are complete, consistent, accurate, trustworthy, reliable and that these characteristics of the data are maintained throughout the data life cycle. The data should be collected and maintained in a secure manner, so that they are attributable, legible, contemporaneously recorded, original (or a true copy) and accurate. Assuring data integrity requires appropriate quality and risk management systems, including adherence to sound scientific principles and good documentation practices.This course is detailed course which includes first two short video lectures which will give practical and simple insight about Data Integrity and Audit Trail Review.Furthermore, there are recorded webinars which explains in details about;Data Integrity with practical approach, A separate dimension and that is , Data integrity Vs. Good Documentation PracticesThere are separate lectures for data integrity in analytical laboratories (chemical section) and data integrity in microbiology laboratories.Further, there is one detailed lecture on Audit Trail review based on risk based approach. Because, still many companies not implemented audit trail review based on risk based approach.The last lecture is on Pharma 4.0 Which is a need for future pharmaceuticals.It's a fundamental part of a pharmaceutical quality system and is important for a number of reasons, including;Ensuring drug qualityData integrity is essential for ensuring that medicines are safe, effective, and meet quality standardsProtecting public healthData integrity is a tool for regulatory authorities to protect public healthEnabling informed decision-makingData integrity makes data valuable and enables informed business decisionsAdhering to regulationsData integrity ensures adherence to life sciences and pharmaceutical regulationsData integrity is important at every stage of production and access, from initial recording through validation and archiving. Failure to comply with data integrity requirements can lead to:Un-validated resultsPost-marketing issuesFrequent product recallsFinesDelays in product approvalCriminal charges
Overview
Section 1: Introduction
Lecture 1 Introduction to Data integrity
Lecture 2 Data Integrity and Audit Trail Review
Section 2: Brief on Data integrity
Lecture 3 Data Integrity - Practical Approach
Lecture 4 Good Documentation Practices Vs Data Integrity
Lecture 5 Data Integrity in Analytical Laboratories
Lecture 6 Data Integrity in Microbiology Laboratory
Lecture 7 Audit Trail Review Based on Risk Based Approach
Lecture 8 Pharma 4.0 - A need for future pharmaceuticals
Professionals of pharmaceutical industry, Quality Assurance, Quality control (Analytical laboratory), production, engineering, R&D, development,compliance team etc.,Auditors, company directors, decision makers, consultants




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