The therapeutics goods industry is stuffed to the gunnels with very smart people; those who know the inside and out of all the processes and procedures in their field. They are the people that you want on board to …
So, you’re working for an exciting brand-new start-up. It’s getting to the pointy end – you understand all your processes, but you need to have these documented and in place to control and direct your regulated activities, ready for …
Corrective and Preventive Action (CAPA) is a key process within a pharmaceutical quality management system. It is the process of identifying and documenting corrections and improvements to systems and processes to reduce the risk of a deviation, non-conformance or …
Data integrity continues to be a focus during US FDA inspections. A number of warning letters issued by the FDA in 2022 highlight the importance of Data Integrity compliance.
In the warning letters issued, the FDA references the FDA’s guidance …
Microlearning can boost your chances of getting an interview when changing careers. Find out how 1-day intensive education courses & GMP eLearning courses can help you (and other job seekers) gain interviews in an unfamiliar industry.
2023 Careers: Job Seeker …
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 …
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 …
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 .
What is meant by the term ‘clinical evaluation’ in the EU MDR?
The EU Medical Device …
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 …
‘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 …
