When handling a pharmaceutical or medical device, it is imperative in the eyes of the regulator, such as the TGA or FDA, that people within your organisation are assigned appropriate roles and responsibilities. One of the most important roles is that of the Authorised Person, who is responsible for authorising steps of the manufacturing process,...
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...
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.
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.
We’re proud to announce that Andrew Giles will be joining SeerPharma as a Senior Consultant based out of our Melbourne office from 21st of March 2016.
How is GMP training managed within your organisation?
There are in essence two ways in which training is delivered to companies; online or instructor-led.
How does each one provide value to your organisation?
The Quality / GMP stream hosted by ISPE at this year’s ARCS congress was a great opportunity to explore the latest issues and trends. Feedback and questions raised during the Quality / GMP sessions identified three current areas of interest to many involved in this area of work. Namely the approach and use of Quality Management Systems, Validation...
Are you a manufacturer working in a regulated environment? Wondering if there is any value on bringing in a GMP consultant? Start with our 5 best tips on choosing and securing a budget for GMP consulting support for your business.
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