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Although the principles of computer validation and compliance are well established, their practical application can be challenging. Good intentions can quickly lead to inefficient and ineffective ways of working. This presentation covers new GAMP guidance on Critical Thinking to optimise validation and compliance. keeping mindful of the quality of finished medicines, patient safety and regulatory compliance. Learn how to get the most of quality assurance and management within the context of the holistic business process being supported.
There are so many promises of the 4.0 world. Why has the adoption in the pharmaceutical industry been so slow relative to other industries? Is it regulations? Is it processes? Is it mindset? This session is intended to dive into some aspects related to quality and, in particular, validation…
To secure product supply many different control strategies are implemented. However, these are rarely connected so a change to one control strategy may impact another control strategy in an unforeseen way…
A lot has happened in the last two years, including: • EMA Notice to sponsors dated April 2020 (EMA/INS/GCP/467532/2019) • EMA GCP Q&A Good Clinical Practice (Question 8/9) in 2021 • EMA IWG Draft guidance dated 10 June 2021 (EMA/226170/2021) Additionally, the E6(R3) EWG is currently working on the…