The US Food & Drug Administration (FDA), European Medicines Agency (EMA) and other global regulators require that employees in the pharmaceutical, medical device and biotech industries are trained to meet compliance standards and have fundamental job knowledge. The Life Science Training Institute (LSTI), a division of Life Science Connect, has developed curriculum that is impactful, convenient and affordable.
Browse our upcoming medical device, biotechnology and pharmaceutical training courses and start on the path to career advancement!
After countless hours putting together your 510(k) submission, the last thing you expect is to get a rejection letter from the FDA. However the odds are against you — between January and June of 2015, 69% of 510(k) applications were rejected their first time. Here are four reasons why your submission might get rejected, and tips to avoid making these mistakes.
In the past 10 years, continuous manufacturing (CM) has gone from theoretical discussion to manufacturing reality. However, the pharmaceutical industry has not yet explicitly defined the term “continuous manufacturing,” nor has it ensured that the term’s usage is aligned with other industries.
It amazes me that, with all the data integrity issues highlighted in regulatory agency inspections over the last several years, very few people I talk with today are familiar with the court case that set the legal precedent for data integrity standards. To me, this is one of the reasons why we see so many data integrity issues — those who forget the past are condemned to repeat it.
Training effectiveness seems to be a topic that is percolating, especially in GMP environments. Yet, it’s shrouded in mystery. No one is clear on what it is, how to implement it, and what the regulators are looking for when it comes to effective training.
Accelovance, Inc. (Accelovance), a global contract research organization (CRO) focusing in vaccines, oncology, and general medicine clinical research held a graduation ceremony yesterday for Accelovance Academy's inaugural class of Clinical Research Associates (CRAs).