The Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a non-profit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance...
This article was originally published by SeerPharma's business partner MasterControl and is republished here with their permission.
Some medical devices are as complex as a remote, personalized heart failure sensor. Others are as simple as a tongue depressor. But all medical devices have one thing in common: they benefit immensely from being...
SeerPharma’s core mission is to advance Quality and GMP-Best Practices for the Pharmaceutical and Medical Device sector. To help us achieve this goal, we partner with the University of Technology Sydney’s Graduate School of Health to offer Postgraduate qualifications in GMP. Pharmaceutical and Medical Device manufacturing are essential industries,...
Teresa Domagala is the Director of Manufacturing Development in Innovative Biologics with a multinational pharmaceutical organisation. In her current role, Teresa overseas a team of scientists responsible for assessing the developability of therapeutic candidates and subsequently isolating and characterising cell lines for their expression.Teresa...
Things that you typically look out for when conducting a Good Manufacturing Practice (GMP) supplier or internal audit and typical observations you see during a GMP Inspection.
In previous articles, we looked at reasons to rethink and simplify the approach to Computer System Validation (CSV). This highlighted a system level ‘macro risk’ assessment using several key factors (including GAMP category and direct/indirect product impact) to determine an overall Risk Profile Score; and then a GAMP functional risk assessment...
The Translational Research Institute (TRI) is a unique, Australian-first initiative of ‘bench to bedside’ medical research. TRI combines clinical and translational research to advance progress from laboratory discovery to application in the community.
Kunal Gadhvi is a Quality Assurance Manager for a multinational compounding pharmaceutical operation and is based in Sydney. In his current role, Kunal oversees the Quality Management System and is responsible for batch release, validation, QC and regulatory submissions.
He is one of many experienced industry professionals pursuing a Postgraduate...
This article was originally published by SeerPharma's business partner MasterControl and is republished here with their permission.
Lina Sandberg is a Quality Assurance Manager for a Regenerative Medicine Manufacturer in Perth, and one of our online students pursuing a Postgraduate qualification in Good Manufacturing Practice (GMP) from the University of Technology Sydney.
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