Since 2015, the EMEA has been working on the revision of Annex 1 of Volume 4 of Eudralex, which deals with the manufacture of sterile medicinal products. This revision was under call for comments until July 2020. To date, there are no details on when and how the revision will be implemented, however operators are starting to prepare for its arrival. In this video, an expert presents a field experience of how to implement improvements in order to meet the requirements. This webinar was given in French by Jean-François accompanied by Gabriel. If you are interested in technical webinars go to N'tech, the platform creating a network of experts through events: www.ntech-events.com Check here other videos on: - The application of ultra-filtration in the pharmaceutical industry: https://youtu.be/HR4ejC2-PaI - Risk Analysis: https://youtu.be/ttOyhKU5CRI #annexe1 #annexe1eudralex

In this video (in French), you will see the main principles of #ultrafiltration, how it works and the parameters influencing the quality of the product. The presentation then focuses on the application in the pharmaceutical industry. Through this illustration, the notions of CPV (Continued Process Verification), maintenance and process steps are addressed. The webinar was a real discussion between the speakers and participants who could ask their questions directly during the presentation. This webinar was given in French by Nicolas and Yves. If you are interested in technical webinars go to N'tech, the platform creating a network of experts through events: www.ntech-events.com Check here a webinar on data integrity and its application to CSV https://youtu.be/r_4ax-dL1ms

In this video (in French), you will be presented with the RCA (Root Cause Analysis) approach based on a sequence of several simple tools that allows to find and then eliminate the cause of most quality, production... and even everyday problems. This presentation is illustrated by an example of a root cause investigation of a quality complaint. Just like for a police investigation, where you have to find evidence, determine suspects, check alibis and finally find the culprit, in the RCA method, the most obvious suspects are not necessarily the culprits. From the Ishikawa diagram and the 5M to the 5 Why, this method enables to get to the roots of any problem. This presentation was given by Anne, Life Sciences engineer. If you are interested in technical webinars go to N'tech, the platform creating a network of experts through events: www.ntech-events.com Check here a webinar on Improvement tools for better CAPA coordination https://youtu.be/jPJzjEY6b5k #Rootcauseanalysis #problemsolving #assurancequalité

In this video (in French) you will be presented with the principles to be applied in terms of data integrity, how to translate them into requirements for software and finally you will have a look at the APIC method to do a risk analysis. The webinar will be divided into 3 parts: - Explanation of the ALCOA+ principles - Application to the CSV domain - Risk analysis of systems This presentation will be given in French by Sébastien, Senior Validation Engineer and Mathias, Qualification Validation Engineer. If you are interested in technical webinars go to N'tech, the platform creating a network of experts through events: www.ntech-events.com Check the webinar on "Risk analysis: the key point of the qualification process": https://youtu.be/ttOyhKU5CRI #dataintegrity #csv #metadata

In this video (in French) you will have the opportunity to learn more about the two project management methods PRINCE II and PMP. You will discover their main principles as well as the advantages and disadvantages of each of these methods. This is not an official training from the PRINCE II or PMP certifications. This webinar was hosted by Christophe Monseu, Senior Project consultant and Loic Marouteau PMP certified engineer. If you are interested in technical webinars go to N'tech, the platform creating a network of experts through events: www.ntech-events.com Check here a webinar on Improvement tools for better CAPA coordination https://youtu.be/jPJzjEY6b5k #projectmanagement #prince2 #pmp

In this video (in French) you will understand the importance of CAPAs (Corrective Action Preventive Action), the key to closing anomalies. Indeed, without #CAPA the anomaly is likely to occur again. The first part is dedicated to explain what a CAPA is and the different incoming flows allowing its creation. Then in a second part, you will discover the different tools allowing the management of CAPAs, because we can be quickly overwhelmed when CAPAs accumulate without an optimal coordination. This webinar was hosted by Sandrine, quality assurance engineer in the Nalys Life Sciences division Here you will find another video on Risk Analysis - the key point of the qualification process: https://youtu.be/ttOyhKU5CRI If you are interested in technical webinars go to N'tech, the platform creating a network of experts through events: www.ntech-events.com #ameliorationcontinue #assurancequalite

Everything you need to know about risk analysis. In this video (in French) you will discover (or rediscover) 3 risk analysis methods that can be used throughout the qualification process, from the beginning of the process when defining the tests to maintaining qualified status. On the agenda: - Quick reminder of the regulatory context - When to use criticality analysis in relation to the v-cycle? - Examples of analysis tools : o the quality complexity index o AMDEC o risk analysis o component function criticality analysis - Q&A section This webinar was hosted by Olivier, Senior consultant in the Life Sciences division at Nalys. If you are interested in technical webinars go to N'tech, the platform creating a network of experts through events: www.ntech-events.com Check here a webinar on Improvement tools for better CAPA coordination https://youtu.be/jPJzjEY6b5k #analysederisque #riskanalysis