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...
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...
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.
SeerPharma collaborates with the University of Technology Sydney to offer internationally recognised Postgraduate qualifications in Good Manufacturing Practice (GMP). The content of the program has been developed by industry experts at SeerPharma, who have held Quality, Manufacturing and Production management positions in the Pharmaceutical sector.
The Pharmaceutical and Medical Device industries rely on a fragmented and complex supply chain to get product in to market. Your organisation or your suppliers could be conducting a single step or multiple steps of manufacture, and as such must adhere to the principles of GMP that apply to your operation and the market in which your product is...
“Our goal is to determine if the firm’s manufacturing operations are in a state of control. The CGMPs are a management-based regulatory approach. We do not specify how a company must structure its quality system. The regulations provide general expectations and we let the firm’s management structure its GMP compliance program accordingly. A GMP...
The Corrective and Preventative Action (CAPA) system is central to every Quality Management System (QMS). Quality professionals know the importance of managing CAPAs when a quality event occurs.
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