GMP Training
In 2019 personnel qualifications (211.25[a]) were cited as 483 observations 113 times. You need GMP training. Even if you are a virtual company, anyone who signs off on GMP documents from contractors needs to have documented GMP training. Implementing a GMP culture early in your company can facilitate future filings as well, by creating more compliant documentation.
Basic and Refresher Courses for Employees
All pharma manufacturers know they need a GMP training program, and many have their own training department. For smaller companies GMP training – at least annually – is also a requirement, even if no manufacturing is being done. Anyone who is going to make any decisions regarding a drug produced for their company needs GMP training. CMC Compliance Services makes GMP training informative, while also making it interesting enough to keep everyone awake.
GMP Training for Executive Management
It often happens that a position in executive management is filled by someone with a good track record in that position, but not necessarily with experience in that industry. For non-pharma executives moving into the pharma industry this can be a thoroughly perplexing situation, but more importantly it can lead to decisions made without adequate understanding of the industry and regulatory requirements. CMC Compliance Services provides GMP training for executive management that places emphasis on the regulations, how they affect business decisions, and the consequences for executive management for violation of the regulations.