Resources & Inspiration
Are you inspection ready?
Raise your hand if you have mixed feelings about inspections, regardless of whether they’re internal audits, the ones from your client/MAH or, perhaps the scariest,
A practical guide to lean CQV (Commissioning, Qualification, Validation)
Through the many different iterations of the CQV model, from the traditional V-model to the hybrid approach to the risk-based approach, a significant amount of time and effort has been spent demonstrating to regulatory inspectors…
Why pharma companies need paperless validation
As previously discussed in my earlier blog post on “What is paperless validation in the pharmaceutical industry”, we looked at the driver for a paperless
Using Kneat in process validation for the pharma industry
Our client’s email mentioned: “As we are considering using Kneat as a digital tool for Validation activities within the project, we would like to organize
What you need to become a CQV engineer in the pharma industry
In our previous posts, we explained why there is no better time than now to work in the pharmaceutical industry. It is especially true for
How to provide effective GMP training in the pharma industry
Article 7.4 of EU Directive 2003/94, which lays down the principles and guidelines of GMP, requires that: ‘The personnel shall receive initial and ongoing training,
Deviation and CAPA Management Training for the pharma industry
Key learnings from NSF International’s training program The Deviation and Corrective and Preventive Action (CAPA) Management training by NSF has further developed my understanding of
What is a Project Management Professional (PMP) Certification in the pharma industry?
Project Management Professional (PMP) is an international certification in project management. PMP demonstrates the education, skill, understanding, and competency required to be effectively involved in
