Beyond the Critical Path: Building Resilient Pharma Project Plans
I love the smell of a fresh Gantt chart in the morning. It’s the only time the project is actually on schedule.
Meet the Team: Petia Ivanova
Meet Petroslava “Petia” Ivanova, our Aseptic Filling & Sterile Manufacturing SME:
Meet the Team: John Storrie
We would like to introduce you to John Storrie, our Environmental Monitoring and GMP Training expert:
Bioprocessing Facilities: Where Risk Management is Our (Slightly Neurotic) Superhero!
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.
FDA PAI Prep: The Aseptic Olympics Are Coming
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.
De-Risking Aseptic Cleanroom Design: The New Mandate Post-EU GMP Annex 1 (2022)
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.