SeerPharma Blog

Vertex Pharmaceuticals Selects SeerPharma GMP eLearning for Global Use

October 06, 2020

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...

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Computer System Assurance - Configuration / Design & Closing the Loop

September 30, 2020

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:

  • Forces requirements to be testable (described in the test cases)
  • Forces thinking using ‘what if’ scenarios on requirements...
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2020 PDA APAC Pharmaceutical Manufacturing & Quality Conference

September 15, 2020

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...

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Overview of ISO 13485 – Medical Device QMS Requirements

September 09, 2020

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...

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Good Manufacturing Practice Online Information Session: 28-Sep-2020

September 07, 2020

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...

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Meet Online Postgraduate GMP Student - Teresa Domagala

September 01, 2020

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....

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Audit and Inspection Insights from a Former GMP Inspector

August 25, 2020

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.

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Computer System Assurance (CSA) - Use of Critical Thinking

August 18, 2020

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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SeerPharma Sponsors TRI 2020 MedTech & Pharmaceutical Career Symposium

August 13, 2020

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.

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Meet Online Postgraduate GMP Student - Kunal Gadhvi

August 06, 2020

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...

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