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.
UPCOMING LIVE COURSES
101 INTRO LEVEL COURSES
View all 101 Level Courses.
STAY TUNED WITH US
Subscribe for the latest pharmaceutical, biotechnology, and medical device training courses and special offers.
When looking at most job descriptions in GMP companies, they now require a college degree. This leads to the question: Are we overvaluing educational degrees and undervaluing experience in our hiring practices and position expectations?
Small to midsize pharmaceutical or biotech companies (small pharma) are enjoying the best of times. However, from a quality systems perspective, it could be the worst of times. Many have weak quality systems, are not following global regulatory authority regulations and/or guidance, or lack the level of documentation required to reconstruct every aspect of clinical trials.
This article describes the basic principles of inductively coupled plasma mass spectrometry (ICP-MS), which is one of the recommended techniques for carrying out the elemental determinations.
Are you ready to give the FDA more? “What?” you ask, as a manufacturer of API and finished goods. Are you ready to give them more data and information about your manufacturing process? You think, “Don’t they get all the necessary information from me during their inspections and from my filings?” Well, the answer is yes and no.
The draft guidance document provides recommendations regarding the testing for RCR during the manufacture of retroviral vector-based gene therapy products, and for follow-up monitoring of patients who have received retroviral vector-based gene therapy products.
The FDA recently issued for public comment six draft guidance documents intended to serve as part of a modern, comprehensive framework for how CBER will help advance the field of gene therapy. This article summarizes the first of those draft guidances, Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs).
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.