COURSE overview
On the 12 June, we will be running a one day workshop to discuss Data Integrity – which is still a hot topic in the Pharmaceutical Industry as regulatory data generated continues to evolve in line with enhanced regulatory requirements, technology and the increased complexity of supply chains and ways of working.
Assuring data integrity throughout the data lifecycle is not new but the guidance from the regulators has recently been updated, and there is still a mountain to climb.
Handwritten records, audit trails, computers, meta data, apps and interfaces - data is everywhere! The Pharmaceutical Quality System (PQS) needs to be designed to make it easy to assure that the possibility for inadvertent or deliberate corruption of data is minimised.
This workshop will provide you with the opportunity to learn more about the latest thinking and compliance requirements on Data Integrity.
Suitability
This is a must attend workshop for trainee QPs, practising QPs, Laboratory Managers, Regulatory and Quality Professionals.
At the end of this workshop you will:
- Gain an understanding of the MHRA/EMA/FDA/PIC/s Data Integrity Guidelines
- Review case studies of Data Integrity breaches to understand how they happen and how to prevent them
- Discuss best practice for assuring data integrity throughout the quality system and pharmaceutical supply chain
