Microlearning can boost your chances of getting an interview when changing careers. Find out how 1-day intensive GMP training / education courses & GMP eLearning courses can help you (and other job seekers) gain interviews in an unfamiliar industry. 2023 Careers: Job Seeker GMP Training Options How is anyone supposed to figure out which career…
What is the current number of medicinal cannabis prescriptions in Australia so far? In just a few years, the number of medicinal cannabis prescriptions through the Special Access Scheme B (SAS-B) has grown substantially. It still represents a small percentage of the overall Australian population who state they rely on cannabis for medicinal purposes. Only…
We are proud to say that PharmOut is now a carbon neutral practice, in doing so reaffirming our commitment as a sustainable global consultancy practice. As a means of continuous improvement, this continues to prepare us for the challenges that face us in the responsible design and operation of buildings in working to reduce carbon…
In this blog I would like to share my 10 tips for writing user friendly SOPs as part of your GMP Pharmaceutical Quality System. The other day I was informed by a client that no-one on their site reads procedures and the only function SOPs performed was ticking a compliance check-box. In my experience this…
Clinical Evaluation EU-MDR requirements This article provides a brief overview of Clinical Evaluation requirements as described in the European Medical Device Regulation – EU MDR [Regulation (EU) 2017/745]. What is meant by the term ‘clinical evaluation’ in the EU MDR? The EU Medical Device Regulation (EU MDR) defines clinical evaluation as “a systematic and planned…
Once the Pharmaceutical Quality System (PQS) (as per ICHQ10: Pharmaceutical Quality System) is implemented, it must be ensured that it continues to be effective, and for this to happen there has to be a clear commitment from senior management to a Quality Culture. There are several ways senior management can demonstrate their commitment to the…
‘Continuous Improvement’ or ‘Continual Improvement’ within a quality system can be described as a process of ongoing improvement of products, services or processes through incremental and/or breakthrough improvements. Within the Pharmaceutical Industry, it’s important that companies ask themselves how continuous improvement has been built into the Pharmaceutical Quality System (PQS). The term may appear in…
FDA Citation Tracking Tool Updated I’m excited to share that QikSolve has helped us to update track and trend all the FDA inspection 483 citations from 2011 to current months. This tool dynamically scrapes data from various live websites and databases and provides a single, secure portal which to track and trend data, or rather…
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