course topics, from R&D and clinical trials to manufacturing, global regulatory, and post-market concerns.
instruction from the best Subject Matter Experts in pharma, biotech, and med device.
content that provides you with practical solutions to the toughest challenges.
features for the adult learner including polling, break-outs, and assessments.
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101 INTRO LEVEL COURSES
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We control our processes through our SOPs, as we should. But where many of us have gone wrong is that we teach people to blindly follow the SOP.
Have we as an industry eroded — or worse, driven out — people’s ability and motivation to think?
While a high percentage of FDA 510(k) submissions are rejected the first time (69%!), yours doesn’t have to be one of them.
Without an outcomes based approach where you are ensuring training effectiveness, your employees’ performance will continue to suffer and so will your quality.
An intro to the FDA’s new draft guidance for Technical Considerations for Additive Manufactured Devices.
This article will provide regulatory context, address confidentiality concerns, and walk through an application based on an actual FDA 483.
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Thanks to our relationship with LSTI and an outstanding team here at Accelovance, we have built a training program that is able to be leveraged moving forward to address an industry need.
My main reason for taking the course was to re-evaluate quality agreements and how to improve our current template. Coming out of this, I would like to compare a few of our supplier quality agreements against the structure and checklist given in the course to see how they align.
Cook Pharmica LLC
All parts of the training were useful, including the topics of Documentation, Change Control and Revisions. I will now review our current Quality Agreement to make sure the requirements are included, and if not, add them.
I took the course to get a better understanding of FDA requirements. As an ISO 9001 registered organization, we need to control and cooperate with suppliers and this gave me some ideas on more formal ways to do that. The webinar was easy to attend with clear audio.