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.
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...
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 to bring all of you under the one roof. With this in mind, we’d like the day to focus on “How...
Your quality systems and procedures are in place, however no matter how much you try, people still don’t fully comply with them. These deviations and subsequent investigations lead to lost productivity. Typically, manufacturers identify “human error” as the root cause and assign corrective actions to train/re-train the team.
