This course covers the key concepts of Record and Data Integrity and Electronic Records and Signatures, including the key regulatory requirements and expectations (including Annex 11 and Part 11, and related guidance), example citations, and pragmatic industry good practice.
Regulators and Health Agencies are continuously stressing the importance of the topic
Data Integrity is a significant theme in many recent regulatory citations
Record and data integrity are an essential part of the pharmaceutical quality assurance system and essential to operating in compliance with GxP requirements
A secure foundation of data integrity is vital to protect the quality of the product and the safety of the patient

This course will help you understand the requirements and apply practical current industry good practice, to ensure compliance and to manage quality risk.

Anyone involved in GxP IT, manufacturing systems, laboratory systems, and IT infrastructure. This includes any IT or related service providers (including cloud providers), and providers of software products, or computerized systems and equipment to life science companies.

For example; Validation professionals, IT, Engineering, Quality Assurance, Qualified Persons, Quality Control, Process Owners including manufacturing, laboratory, clinical, PV and GxP other processes), System Owners, Project Managers, and consultants.

PROGRAMME

This course covers the following topics :

Definitions and key concepts

Applicable regulations (Annex 11, Part 11)

Regulatory guidance – and what they mean in practice

Data audit trail and data audit trail review

Regulatory Citations and how to avoid them

Industry good practice

Data Governance

The Data Life Cycle

Achieving compliance in an effective way

Application of ideas and concepts to your systems

By the end of the course, you will understand:

Definitions and key concepts

Applicable regulations (Annex 11, Part 11)

Regulatory guidance – and what they mean in practice

Data audit trail and data audit trail review

Regulatory Citations and how to avoid them

Industry good practice

Data Governance

The Data Life Cycle

Achieving compliance in an effective way

Application of ideas and concepts to your systems