When the U.S. Food and Drug Administration (FDA) initiates the recall of a product, it’s costly for life sciences companies, causing significant financial losses, reputation damage, and even legal repercussions. In the past several years, FDA recalls have been on the rise, especially in the...
A multinational manufacturer of cardiovascular devices recently engaged SeerPharma to conduct a comprehensive mock US FDA audit of their operations in Singapore. The audit was conducted against US FDA 21 CFR Part 820 – Quality System Regulation (21 CFR 820). SeerPharma reviewed relevant documentation remotely and then spent three days on-site...
KENX is a leading knowledge exchange network in the life sciences industry, at the forefront of coordinating and running events focused on making pharmaceuticals and devices safer. The organisation achieves this by bringing together regulators and industry leaders to address the latest industry trends, regulatory changes, business challenges and...
In 2014, the FDA issued a guidance document for the Management of Cybersecurity in Medical Devices – Content of Premarket Submissions. Since then, technologies and the interconnectivity of medical devices have evolved rapidly. In response, the FDA released a new draft guidance in April 2022, for comment purposes only - Cybersecurity in Medical...
Chemika is an independently owned chemical analysis laboratory located in Girraween, Sydney, and is licensed with the Therapeutic Goods Administration (TGA) and the Australian Pesticides and Veterinary Medicines Association (APVMA). Chemika provide chemical testing services to manufacturers of human therapeutics and veterinary medicine. Services...
Pharmaceutical firms in India have turned to SeerPharma for assistance on matters of Quality Assurance and GMP compliance.
SeerPharma (Singapore) was engaged by a company in Singapore to help implement cGMP for a new clinical trial packaging facility and obtain international certification of conformance to FDA, EMA and PIC/S GMP.
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...
As a manufacturer or sponsor of a pharmaceutical and/or medical device, you need to ensure control over component and product quality, as well compliance with legal and customer requirements. Establishing and maintaining a supplier quality assurance program can be a challenge, with regulatory requirements and supply chain complexity continuing to...
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.
Copyright © SeerPharma
