| Course | |||||
|---|---|---|---|---|---|
 | Internal Trainings / CSV Foundation What information is useful when entering a validation project at a customer? We will talk about what to expect as a consultant and the different approaches to CSV that we may meet in the Life Science industry. This is the second of 4 training... | ||||
 | Internal Trainings / CSV Advanced - Part 1 What processes does CSV consist of and how do we document? This course describes the fundamental requirements of how/what to document during a software validation project. How to work smarter and not harder with a structured approach to organize... | ||||
 | Internal Trainings / CSV Foundation Here we will interduce the GAMP 5 practice of validating computerized systems and how to use the supporting processes throughout the system lifecycle ensuring that we meet the regulatory requirements. This is the first of 4 training session in the... | ||||
 | Internal Trainings / CSV Foundation Data integrity refers to the accuracy, consistency, and reliability of data throughout its lifecycle. At this training session we will go through the regulatory requirements for data integrity, how we may identify critical data and ensure... | ||||
 | Internal Trainings GMP (Good Manufacturing Practice) refers to the quality systems commonly applied in pharmaceutical production. However, other sectors within Life Sciences, such as the development and manufacturing of medical devices, must also adhere to similar... | ||||
 | Internal Trainings / CSV Advanced - Part 1 One thing is validating a computerized system- but how do we keep the system in a validated state? Join this training session and learn about what it takes and what quality processes and activities are needed to keep a computerized system in a... | ||||
 | Internal Trainings / CSV Advanced - Part 1 IT Quality Risk Management: First a short intro to Life Science Quality Risk Management following the ICH Q9 process, and then we will go deeper on Quality Risk Management related to IT. IT quality risk management involves identifying, assessing,... | ||||
 | Internal Trainings Life Science intro is a short intro to the Life Science industry, the background of the industry today, a description of the different industry types, the most common regulators and regulations, the consequents of not being in compliance with the... | ||||
 | Onboarding A brief overview of the Hørsholm office in Denmark and the facilities it offers. | ||||
 | Onboarding A brief overview of the Titanhus office in Denmark and the facilities it offers. |
