Visit www.brookwood-global.com for further details and to order online • ONLINE TRAINING • GCLP Regs RM MD GMP NIS CDM PV GDPR GCP Stats 19 Data Integrity Data integrity is currently a major focus area during regulatory inspections. It is therefore essential that your team have the correct understanding of what is required. This online data integrity course covers the background to data integrity, why it is important and how its requirements affect both paper-based and computer-based systems. This 20-minute online data integrity course will give you and your team a clear understanding of your role in meeting the expectations of European inspectors and the FDA. GMP Course content • What is data integrity? • Why it is important • The ALCOA principles for paper-based, computer-based and hybrid systems • Application of the ALCOA principles • ALCOA+ update • The importance of metadata • Positive Quality Culture • Assessment At the end of the online data integrity course there is a series of randomly selected assessment quiz questions. An 80% pass mark is expected to successfully complete the course. Guidance is provided if a delegate gets an answer wrong. Once you have completed the course you will be able to print a certificate including the RSC ‘Approved Training’ logo. This course has been approved by the RSC The course is based on the guidance given in the European Medicines Agency “Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples”, adopted by the GCP Inspectors Working Group in 2012. It covers the most important aspects in the Reflection Paper and offers practical advice on how and when a laboratory should comply. The program also covers some GCP basics to fulfil the requirement that laboratory staff have relevant GCP knowledge. For details of packages for training larger groups contact us at info@brookwood-global.com
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