- 10 July 2018
- 1:00pm - 1:30pm GMT | Webinar, United Kingdom
Presented by ex-MHRA inspector Rachel Carmichael, this webinar covers how the best companies respond in a crisis, using systematic approaches to make the right judgement.
Specifically, we focus on understanding the extent of the quality defect, bringing together a strong cross-functional and acting in a timely manner.
We also consider the effectiveness of different types of CAPA – particularly why the obvious trio of “discipline, training and procedures” is not good enough.
About the presenter
Rachel Susan 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.