SeerPharma has assisted an Australian 3D Printing Medical Device company to develop an ISO 13485 compliant Quality Management System (QMS).
As a Medical Device company, you are required to investigate the cause of quality failures or production problems. Surprisingly though, “Failure to thoroughly investigate…” is a common finding from quality (management) system inspections and audits against FDA 21 CFR Part 820 and ISO 13485.
An Australian pharmaceutical company engaged SeerPharma to prepare them for a TGA and FDA GMP inspection. Their Engineers were relatively inexperienced in dealing with regulatory inspections and the company required them to gain experience quickly in preparation for the FDA’s arrival. SeerPharma were requested to perform a mock audit to help meet...
Linear Clinical Research specialises in the conduct of early phase clinical trials and has a purpose built phase I facility to support first-in-human through to phase II clinical trials.
A multinational pharmaceutical company has been using SeerPharma’s online GMP training solution "E-learning" for new employee and refresher training since October 2012. With additional staff coming on board, SeerPharma has altered the implementation model to provide the client with more functionality as well as the independence to self-manage the...
A US-based biopharmaceutical firm has approached SeerPharma to perform audits of their critical service providers. The company is about to undertake a phase I clinical trial in Australia of one of its therapeutic molecules.
Health World Limited has grown to become a market leader and one of the most trusted suppliers of Complementary Medicines in Australia and New Zealand. Much of Health World Limited’s success is due to its strict adherence to its mission of helping people live happier, healthier lives and the company uses SeerPharma for its GMP training.
A major Australian manufacturer of medical devices has engaged with SeerPharma to deliver a customised program on computer system validation (CSV). The course looks to address content such as agile processes, cloud computing and automated testing drawing on SeerPharma’s experience with the regulatory (GMP) framework and incorporating case studies...
It is imperative that Pharmaceutical companies have a good handle on how to perform Product Quality Reviews (PQR). In fact, effective PQR’s are necessary in demonstrating GMP compliance to regulators such as the TGA and FDA (Annual Product Review).
We invite you to attend our inaugural SeerPharma Symposium, which will be held at the Park Hyatt, in Melbourne on Friday the 20th of May.
After 25 years of serving pharmaceutical and medical device professionals in the Asia-Pacific region, we would like bring all of you under the one roof. With this in mind, we’d like the day to focus on “How you...
