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CPD Hours: 7
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.
This course will help you understand the requirements and apply practical current industry good practice, to ensure compliance and to manage quality risk.
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.
This course covers the following topics:
By the end of the course, you will understand:
We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.
Sion is an acknowledged expert in computer system validation and compliance and international regulations in this field. He assisted the FDA as a consultant with its re-examination of 21 CFR Part 11 and was a member of the core team that produced the FDA Guidance on 21 CFR Part 11 Scope and Application. He received the FDA Group Recognition Award for work on Part 11.
GxP computerised systems validation and compliance
This course covers the key concepts of GxP computerised systems validation and compliance, including the key regulatory requirements and effective industry good practice based on GAMP®5