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Assuring Data Integrity in the Manufacture of Medicinal Products
Course Summary
Pharmaceutical and biotechnology companies and researchers need to assure regulatory authorities of the reliability of the data that they generate or acquire during product development and manufacturing – that is, to demonstrate data integrity. Data integrity is assessed during regulatory inspections of manufacturing and research sites. Inadequacies of data integrity are frequently reported by inspectors and result in regulatory actions against the companies or individuals concerned. Practices that assure data integrity are required by law and/or expected by regulators in the fields of nonclinical and clinical research, manufacturing and distribution, and pharmacovigilance of medicinal products.
This course explains the requirements and describes principles and practices that should be followed to assure regulators and contractual partners of data integrity in the manufacture of medicinal products.
Purchasing Information
When you have completed your course order, Zenosis will finalise the setup of your course materials and contact you on the email address that you provide in your order. You can expect this process to be completed within one business day (using the UK business calendar) of completing your payment.
It is therefore essential that you use your real email address for your order, or indicate in the purchase notes the email address to be used for the course set-up, and check that any messages from Zenosis or grapl are not lost in your junk or spam folder.
You will have access to the course module(s) for a period of 180 days after your purchase is complete.
Detailed Course Information
Learning Objectives
• Define fundamental concepts of data integrity and outline how they are applied in manufacturing
• Identify failures of data integrity that may be found by regulatory inspectors, and the unacceptable practices that give rise to them
• Comply with legal requirements and regulatory expectations concerning paper-based data
• Comply with legal requirements and regulatory expectations concerning electronic data
Who will benefit from this course
This module provides essential learning for all personnel who work in a medicinal products manufacturing environment.
Module Outline
Data integrity definitions and fundamentals
– What do we mean by data?; What is data integrity?; ALCOA and ALCOA+; Raw data and metadata; Transcription and transformation of data; Static and dynamic data; True copies; Archiving and retention; Validation of computerized systems; Data governance; Key questions to answer; Unacceptable practices; Regulators’ responses to data integrity failings
Integrity of paper-based data
– Control of paper-based data; Recording data on paper; Making handwritten corrections; Verification of records (secondary review); Signatures and delegation; Storage, archiving and retention of paper records
Integrity of electronic data
– Restrictions on access to computerized systems; Data entry/capture; Audit trails; Review of data; Protection of data; Storage, backup and archiving; Data transfer and migration; Electronic signatures; Reporting, investigation and correction of data integrity issues; Outsourced activities
Roles
Medicinal products manufacturing personnel and management
CPD Points
1
Region
Level
Introductory
Course Study Time
1 hour
Europe, USA, other