BioMelbourne Network is an industry-led membership association for organisations engaged in biotechnology, medical technology and health innovation in the state of Victoria, Australia. BioMelbourne Network plays a pivotal role in fostering links between companies, research organisations, financial markets and government in Australia’s largest...
With cloud infrastructure now in place in Australia, Singapore, Japan, China and India through Amazon Web Services (AWS), MasterControl have launched their latest Manufacturing Software Solution – Manufacturing Excellence (Mx) to the Asia-Pacific market.
Vertex Pharmaceuticals, Inc. is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. Vertex has multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) — a rare, life-threatening genetic disease — and several ongoing clinical and...
In the previous article, we looked at including Test Cases and the Functional Risk Assessment into the Functional Requirements Specification. This provided multiple benefits over maintaining these as separate documents:
The Parenteral Drug Association (PDA) is a 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...
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