PQE Group

Don’t know which areas of your #pharmacovigilance system need attention or what steps to take? Take the free PQE Group pharmacovigilance self-assessment: https://lnkd.in/gvy5MKfu Being compliant is no longer sufficient on its own; regulators now expect clear evidence, traceability, and continuous oversight. To avoid costly findings and ensure compliance, it is now more important than ever to proactively assess your systems and address potential gaps early. This quick self-assessment is the right place to start if you want a clear understanding of where your systems stand and where improvements are needed! #Pharmacovigilance #SelfAssessment #ProactiveCompliance #LifeScience #PQEGroup

The ISPE Annex 1 Symposium in Lyon is almost here! We are only a few days away from gathering at this innovative event that brings together so many brilliant minds from around the world. From May 18–19, I'll be chairing the symposium alongside Richard Denk and Jean François DULIERE at the historic Palais de la Bourse de Lyon. The elegance and craftsmanship of this venue reflect the significance of the work we’ll be leading within its walls, exploring the challenges and evolving expectations introduced by the revised EU GMP Annex 1 for sterile pharmaceutical manufacturing. This symposium is built around open and honest exchange with practitioners, regulators, and industry experts working together in the same room through real challenges. The workstreams are designed to go beyond theory and get into the practical realities our industry is actually dealing with. I can’t wait. If you will be in Lyon, make sure to come say hello to our PQE Group team! Register here: https://lnkd.in/d8Cu4kSd

Explore PQE Group’s Commissioning, Qualification, and Validation ( #CQV ) Services 👉 https://lnkd.in/gqgbu8u9 Having a solid Commissioning, Qualification, and Validation (CQV) strategy is what separates proactive, well-controlled operations from constantly having to fix issues as they arise. Organizations that treat CQV as an ongoing commitment rather than a one-time activity are better positioned to maintain consistency, stay compliant, and keep their operations running smoothly. Take a look at PQE's CQV services to discover how we can support you in building more compliant, and future-ready operations. #CQVServices #CQVStrategy #LifeScience #PQEGroup

Thank you Copenhagen! 🇩🇰🇩🇰🇩🇰 This past three days have been a blast and it was probably the best conference of the year! (credit to Anders Widov 😉) The vibe and the reconnection with peers, friends and colleagues in our industry is really what makes ISPE a unique platform for knowledge sharing, networking and real friendships. PQE Group is a proud silver sponsor and exhibitor of this important gathering and I have to say our team really rocked the hall! Thank you to the planning committee and the fabulous ISPE staff for making it a success again. It was honestly really refreshing to stay out of the constant news of the wars of our world for few days and see that despite the craziness around us we still have a community based on ethics, respect, diversity and support. By the way: my friend Janie Miller BS, MBA took the selfie of the year 😎

Hello Everyone, I wanted to survey the market and see if anyone has implemented CSA (Computer Software Assurance)and if so I wanted to see if you can provide any information regarding any details/examples of where CSA is being used for Medical devices manufacturing directly in making of the medical device. I appreciate you sharing your details for this during the next few days. If you haven't implemented CSA, are you thinking about it? if so read my article on CSA implementation on Real World case study and contact me/PQE Group for our help to get on the CSA journey!!!