Why eLearning Solves the Manufacturing Training Dilemma.
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Why eLearning Solves the Manufacturing Training Dilemma.

ByMaria

Why eLearning should be part of your regulatory compliance training programs — including during a pandemic. The GMP eLearning Business Case When we consider why eLearning is a valuable addition to GMP training programs, the following concepts come to mind: accessibility, scheduling adaptability, affordability (training cost savings), and regulatory compliance reinforcement. There is no doubt…

Key considerations for cell therapy tech transfer to GMP production

Key considerations for cell therapy tech transfer to GMP production

ByPharmOut

Cell therapy tech transfer blog Despite the no-man’s land between academia and industry is a well-trod area, it is still fraught with pitfalls this is especially the case when it comes to cell therapy tech transfer. While researchers are often frustrated with the overbearing rigour and control that forms the backbone of GMP, the industry…

Australian Regulatory Framework Psychedelic Therapies
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Australian Regulatory Framework Psychedelic Therapies

ByPharmOut

Glancing at headlines these days there appears to be a consistent stream of positive news breaking out all over the world about the potential therapeutic benefits of psychedelics, including a declaration from the FDA that psilocybin is a “breakthrough therapy.” Australia has also been involved in conducting some of the research and there are ongoing…

PIC/S GMPs vs WHO GMPs – what’s the difference?
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PIC/S GMPs vs WHO GMPs – what’s the difference?

ByPharmOut

t]As many are aware, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) develops and provides standards and guidelines for the harmonisation of Good Manufacturing Practice(GMP) in the global pharmaceutical industry. Those who fall under the umbrella of participating countries, often take for granted the fact that PIC/S is the go-to for compliance (i.e. Part 1, Part 2…