A major pharmaceutical distribution organisation engaged the services of SeerPharma (Singapore) Pte Ltd to provide a review on the compliance of its core SAP-Centric solution to the GxP Computer Systems Validation (CSV) requirements of both FDA 21 CFR Part 11 and PIC/S Guide to GMP Annex 11. There were 2 phases to this project.
SeerPharma’s inaugural Symposium was a great success with Operational and Quality Directors from over 30 Pharmaceutical and Medical Device / Medical Technology companies such as CSL, Patheon, Alere Medical and MSD in the crowd.
GMP Data Integrity is an issue that a number of our clients have approached us about recently. The concept of Data Integrity has been around for quite some time, with the TGA introducing the concept of electronic records in to the previous Australian code of GMP back in 1990, while the FDA made 21 CFR Part 11 Electronic records and signatures...
The SeerPharma team has been busy implementing electronic Quality Management Systems (eQMS) for a variety of companies ranging from pharmaceutical, nutraceutical, veterinary and medical device companies.
As a Pharmaceutical 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 regulatory inspections in the PIC/S, TGA and FDA GMP environment.
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.
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...
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 you identify “human error” as the root cause and your corrective action is to train your team.
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