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.
In the Pharmaceutical and Medical Device industries, document control is an essential quality system element and a regulated requirement because written instructions directly affect processes that impact product quality.
For over 30 years SeerPharma has aided Pharmaceutical and Medical Device companies on matters of Quality Assurance and GMP compliance.
The current COVID-19 pandemic is seeing day to day quality related business operations challenged by attempting to deal with multiple personnel across different departments remotely. The need for immediate and...
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