This course introduces Data Integrity; what it means, why it's important, how failures can occur and what can be done to protect it.
Objectives
- Understand what Data Integrity means
- Understand why Data Integrity is a hot topic
- Understand data criticality and data risk
- Understand how Data Integrity problems arise
- Understand who can contribute to good Data Integrity
- Understand how to protect your Data Integrity
Topics and Content
- Introduction
- What is Data Integrity (DI)?
- Objectives
- Reviews and assessment
- Overview
- Data integrity is not new
- Data integrity as part of FDA, EU and PIC/S GMPs
- GMPs for electronic records and computerised systems
- Regulators' perspectives
- Industry guidance
- Risk management and controls
- Raw data and metadata
- Manual and electronic data
- What if the data are unreliable?
- Understanding risk to data integrity
- Good Documentation Practices
- ALCOA+
- Logical design
- Scenarios
- Scenario 1 (digital reading on a pH meter)
- Scenario 2 (Operator is completing a logbook)
- Scenario 3 (Analyst calculates and records assay results in their workbook)
- Scenario 4 (automated chromatography instruments)
- Human error
- Human error and DI
- Human behaviours that help protect data integrity
- Doing the wrong thing for the right reason
- Quality culture
- Controls for paper-based records
- Computer systems
- Errors relating to computer systems
- Leverage audit trails
- Conclusion
- Summary
Participants
This course is designed for induction of personnel new to GMP or as a refresher for experienced GMP personnel in any role because protecting DI is important for all GMP records.
Assessment / Certificate
There is a 10-question quiz assessment at the end of the course with a pass mark of 80% and 3 attempts.
A PDF Certificate is issued upon passing the quiz.
Duration
The course is expected to take approximately 1 hour.
Access
For organisations looking to setup once-off or ongoing training for group of personnel, SeerPharma can create a dedicated company account in our online Learning Management System (LMS) or we can licence courses for you to host in your own LMS or QMS. Request pricing for organisations.
For individuals, you can buy now for $149 (ex GST) and your licence grants you access to the course for 30 days.
Contact us with any questions.
