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SeerPharma Blog

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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Digital Tools to Streamline Supplier Management Processes

August 03, 2020

This article was originally published by SeerPharma's business partner MasterControl and is republished here with their permission.

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Meet Online Postgraduate GMP Student - Lina Sandberg

July 28, 2020

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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Computer System Assurance (CSA) – Risk and Reward

July 20, 2020

In a previous article, we looked at the reasoning behind why the FDA thought there was a need for a change of approach for many companies with their Computer System Validation (CSV). In this article we will look at how a more structured risk assessment approach will lead to greater computerised system rewards – and at a lower cost.

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SeerPharma and UTS to Launch a Subject on GMP Bioprocessing

July 14, 2020

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...

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Your Map to Quality Manufacturing

July 01, 2020

This article was originally published by SeerPharma's business partner MasterControl and is republished here with their permission.

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SeerPharma Engaged to Conduct GxP/GMP Audits in Asia-Pacific

June 24, 2020

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...

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Computer System Assurance (CSA)

June 17, 2020

Computerised System Validation (CSV) is an activity carried out by Pharmaceutical and Medical Device organisations to ensure that IT infrastructure and applications that impact product quality are operating in a controlled state. Organisations must demonstrate an appropriate level of control of their Computer Systems to regulators such as the...

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A Software Solution for Effective Change Control

May 07, 2020

“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...

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Automating Your CAPA System for Effective Quality Management

April 24, 2020

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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