Let’s be honest, managing projects for bioprocessing facilities can feel like herding cats made of critical deadlines, regulatory demands, and a budget that’s always trying to escape.
But fear not, fellow project managers! We’ve got a secret weapon that turns chaos into controlled brilliance (most of the time): Risk-Based Project Management.
We are pleased to announce that our President has been honored with the 2025 Volunteer of the Year Award by Hope for Dementia. This recognition reflects his outstanding dedication, leadership, and commitment to serving others.
New year, same mission — just a little less stress? 🥂
You know that feeling when you’ve just completed a massive project, validation is complete, and you’re ready to ship product? That sweet relief is immediately followed by the cold dread of realizing the FDA Pre-Approval Inspection (PAI) is looming…
In aseptic manufacturing, the PAI isn’t just an inspection -it’s the regulatory World Series, the Aseptic Olympics- success demands a flawless routine without dropping any SOPs. The medal is market access; the judge is the FDA.
The transition to the revised EU GMP Annex 1 (2022) demands a shift from simply building a clean space to engineering a comprehensive Contamination Control Strategy (CCS). Validation issues are often rooted in the design phase, where planning assumptions misalign with operational reality.
If your facility design does not thoroughly address risks associated with operator interventions or material and equipment transfer to sterile areas, you are potentially compromising your sterility assurance.
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