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Presented by: Gaye Camm, Therapeutic Goods Administration
Presented at: RACI PHARMACEUTICAL SCIENCE GROUP (NSW) Seminar/Webinar, ‘Computerised Systems - Establishing and maintaining data integrity’
Presentation date: Tuesday, 25 October 2022
Presentation summary: Australian regulatory requirements for manufacturers of medicinal products when establishing and maintaining data integrity for computerised systems. The presentation included a risk based approach to data management and a discussion of data integrity issues identified during recent TGA inspections.