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SeerPharma Blog

Free Information Session on Upcoming Subsidised QMS Training

July 22, 2021

Research and operations of Medical Technology, Biotechnology and Pharmaceutical (MTP) companies aligned with and in some cases certified to Quality Management System (QMS) Standards will ensure Australia is at the forefront of medical innovation.

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Validation 4.0 – A Near Future State

July 15, 2021

ISPE recently hosted a webinar on Validation 4.0 and where it sat within their ISPE Pharma 4.0TM Operation Model. It was with no surprise that an audience survey rated ‘documentation’ as the biggest hurdle / constraint to validation.

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Assisting an Analytical Testing Laboratory with US FDA Inspection

June 21, 2021

Chemika is an independently owned chemical analysis laboratory located in  Girraween, Sydney, and is licensed with the Therapeutic Goods Administration (TGA) and the Australian Pesticides and Veterinary Medicines Association (APVMA). Chemika provide chemical testing services to manufacturers of human therapeutics and veterinary medicine....

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Meet Mario Cano Gorra - Master of GMP Student at UTS

June 14, 2021

I am a Mexican-born citizen. Since elementary school, I’ve displayed a natural knack for biology, physics, and mathematics. Naturally, I studied a Bachelor of Science in Pharmaceutical Engineering in one of the largest and most prestigious universities in Mexico, the National Polytechnic Institute. Whilst studying I met my wife, and we have...

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Monitoring the Pulse of Precision Medicine: 2021 Trends in Personalised Medicine

June 09, 2021

Let’s just say what we’re all thinking: 2020 was rough. It threw pretty much every element of our lives into disarray, and we suddenly had to become experts at navigating a new way of working, schooling and socialising. It was disruptive, and it was challenging, but it was also transformative. While the past 12 months might have felt like 12...

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Medical Devices: Post-Market Surveillance, Adverse Events and Recall

June 01, 2021

 

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Quality Management under MTP 4.0– Incidents, Suppliers/Material & Risk

May 24, 2021

In the previous 2 articles (linked below) we have looked at what the Quality Management System (QMS) of the near future (Quality 4.0) may look like under MTP 4.0 (Industry 4.0 for the Medical Technology, Biotechnology and Pharmaceutical sector).

Recall that, MTP 4.0 is a holistic operating model that incorporates digital technologies, data...

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MTP 4.0 Quality Management Complaints, CAPA, Deviation, Docs, Training

May 20, 2021

In a previous article we looked at the emergence of MTP 4.0 (Industry 4.0 for the Medical Technology, Biotechnology and Pharmaceutical sector) as a holistic operating model to facilitate an agile development and manufacturing environment for the near future.

Being holistic, the operating model covers all aspects of the business, using a digital...

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Inaugural Recipient of the SeerPharma Scholarship: Harsha Gupta

May 13, 2021

SeerPharma is excited to announce Harsha Gupta as the inaugural recipient of the SeerPharma Scholarship. Harsha is currently enrolled in the C04301 Master of Good Manufacturing Practice (GMP) at UTS and works as a Senior Manager, Manufacturing and Process Development for a company that manufactures allogenic Mesenchymal Stem Cells (MSCs). Prior...

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Quality Management under MTP 4.0 – Audits and Change Control

May 11, 2021

Industry 4.0, or the Fourth Industrial Revolution is a term used to describe the use of smart technology in manufacturing and industrial processes.

ISPE (the International Society for Pharmaceutical Engineering) has trademarked the term ‘ISPE Pharma 4.0’ to cover Industry 4.0 in the life sciences sector.

As the Industry 4.0 concept is equally...

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