A biopharmaceutical manufacturer engaged SeerPharma to provide on-going coaching to their Quality personnel and advise on improvements to help prepare for a FDA inspection.
GMP Data Integrity Masterclass
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...
Pharmaceutical Manufacturers Association Recommends G(QC)LP Services
One of our senior consultants in Singapore, received the following glowing recommendation from the Sri Lanka Pharmaceutical Manufacturers' Association (SLPMA) which is a testament to the quality of our team in Singapore who continually strive to deliver exceptional service to customers in the region.
Good Distribution Practice (GDP) Training in Asia
Zuellig Pharma is Asia’s leading healthcare service provider offering a broad range of innovative services including distribution of pharmaceuticals, medical devices, special solutions and other healthcare related consumer products.
Effective CSV in the Pharmaceutical / Medical Device Industry
You’re a Quality, IT, or Operational manager working for a Pharmaceutical / Medical Device company, responsible for the computer systems used in-house. Working in the Pharmaceutical / Medical Device industry, means that regulators such as the FDA and TGA will scrutinise the use and validation of these business critical systems.