Written and presented by ex-MHRA inspector Rachel Carmichael, this online course provides an overview of the regulatory requirements surrounding data integrity and what needs to be considered during documentation completion, review and approval. This course is the first of what will ultimately be three modules to ensure a broad understanding of the requirement to deliver data that is complete, consistent, accurate, trustworthy and reliable throughout its lifecycle.
This first module is suitable for anyone working in the pharmaceutical industry (GCP, GMP, GLP, PV and GDP) and provides a sound baseline for those working in devices. It delivers an understanding of:
- Key data integrity terms and definitions
- Good documentation practice in relation to data integrity
- Good documentation design to allow good documentation completion
- The five main types of errors within records
- Review and approval of documents, including making corrections
- Audit trail review
- Right-first-time metrics.
Tutor Rachel Carmichael has over 20 years' experience of pharmaceutical manufacture, control and quality management including nearly 11 years as a GMDP Inspector for the UK Competent Authority, the MHRA. This includes serving as the lead inspector representative within the MHRA for the transition from the Medicines Act to the Human Medicines Regulation, SI 2012 1916.
Ms. Carmichael is eligible to act as a Qualified Person under the provisions of EU Directives and is a member of the Royal Society of Biology. She has wide-ranging experience of inspecting against European Good Distribution Practice and Good Manufacturing Practice requirements in the UK, China, India and the US to meet the associated quality standards for medicines (non-sterile and aseptic production, including radio pharmaceuticals) and the blood industry.