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 US...
“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 GMP...
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.
In the Pharmaceutical and Medical Device industries, document control is an essential quality system element and a regulated requirement because written instructions directly affect processes that impact product quality.
For over 30 years SeerPharma has aided Pharmaceutical and Medical Device companies on matters of Quality Assurance and GMP compliance.
The current COVID-19 pandemic is seeing day to day quality related business operations challenged by attempting to deal with multiple personnel across different departments remotely. The need for immediate and...
This article was originally published by SeerPharma's business partner MasterControl and is republished here with their permission.
Digital transformation efforts are accelerating in a variety of manufacturing areas, with upwards of 73% of recently surveyed manufacturers saying they plan to increase their investment in smart factory technology...
In the Pharmaceutical and Medical Device industries, employees can affect product quality so they must be trained and assessed on a variety of documents (policies, SOPs etc.) and tasks relevant to their job role . As a Training Manager your paper-based system requires you to distribute training materials, tasks, reminders and tests in person or...
The University of Technology Sydney (UTS) has scheduled postponed the first "Introduction to Bioprocessing" training session in the new 430m2 Biologics Innovation Facility (BIF) with its cGMP designed clean rooms and containment laboratories.
SeerPharma is excited to welcome the 2020 cohort of students who will embark on achieving Postgraduate Qualifications in Good Manufacturing Practice (GMP) from the University of Technology Sydney. The cohort represent a mix of graduates and working professionals from around the world, some of whom will undertake these studies on-campus in Sydney,...
The University of Technology Sydney (UTS) recently opened its Biologics Innovation Facility (BIF). The 430 square meter facility houses a series of clean rooms and containment laboratories meeting cGMP codes. The facility has been set up to provide the biotech and pharmaceutical sector with an opportunity to have their employees locally trained...
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