The Singaporean division of a global diagnostics equipment manufacturer engaged SeerPharma to deliver training on Computer Software Assurance/Validation and 21 CFR Part 11. Multiple workshops were delivered to over 50 staff, to help them appreciate the regulatory expectations of the US FDA , for the work performed on-site.
A leading sterile pharmaceutical manufacturer in India engaged SeerPharma to assist in responding to a recent TGA GMP audit. As part of its response to the TGA, the company requested SeerPharma to visit their site in Madhya Pradesh. SeerPharma was tasked to assess the clients’ sterile facilities, documentation, quality management system, risk...
Publicly debuted Large Language Models (LLMs), such as ChatGPT by OpenAI (Microsoft), have initiated serious rethinking of business processes across all sectors of the economy. Consultancy firms are not immune from the potential disruption caused by these novel artificial intelligence (AI) tools. Global consulting firm PwC has recently instructed...
The Association of Regulatory and Clinical Scientists to the Australian Pharmaceutical Industry (ARCS) is an eminent organisation that focuses on the professional development of individuals involved in the therapeutic goods industry. To further its mission, ARCS hold an annual conference, which will be run from the 6th-8th of June at the...
SeerPharma has over 30 years of experience, supporting diagnostic manufacturers and laboratories on matters related to Quality and GxP compliance. In that time , we’ve seen the emergence and importance of Point of Care Diagnostics (POCD). Following this trend, we’re delighted to be sponsoring an upcoming Biosymposium by the Biomelbourne Network...
Ethylene Oxide (EO) sterilisation is a commonly used process in the sterilisation of Medical Devices, and combination medicine-devices. The EO sterilisation process is suitable when the products are sensitive to heat, ruling out any heat sterilisation. Sterility occurs when an EO gas molecule diffuses through the cell wall and cell membrane of...
Don’t let your legacy system bog you down. Ensure quality without slowing production with MasterControl Manufacturing Excellence, a modern manufacturing execution system that is as cost-effective, can be installed rapidly, and is flexible enough for even the most complex manufacturing environments. MasterControl helps you eliminate data entry...
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...
This article was originally published by SeerPharma's business partner MasterControl and is republished in-part here with their permission.
SeerPharma is thrilled to welcome the 2023 Autumn cohort of students studying Good Manufacturing Practice (GMP) at the University of Technology Sydney (UTS). This cohort is a blend of graduates and industry professionals. The program continues to grow from strength to strength, and we’re delighted to see a record number of over 60 students enrol...
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