Blue Bell Consulting£ºHome > News > 2008 Report of Regulatory and Compliance Training at BBC
News

2008 Report of Regulatory and Compliance Training at BBC

It has been four years since Blue Bell Consulting first started providing its open training services. Thanks to the close attention and support of numerous drug and medical device companies, Blue Bell Consulting’s open training service...

It has been four years since Blue Bell Consulting first started providing its open training services. Thanks to the close attention and support of numerous drug and medical device companies, Blue Bell Consulting’s open training service has not only been a channel for the staff of the industry to learn more about U.S. FDA regulations and guidances, but even more as a window for more communication and collaborations between BBC and those companies in the pharmaceutical and medical device industries. Through this window, BBC has further increased its ties and mutual understanding with domestic enterprises, in particular the ones with intentions to develop internationally, such as the U.S. FDA application or cGMP compliance; meanwhile it allows for BBC’s level of consulting services, pertaining to U.S. FDA drug and medical device application as well as cGMP compliance, to obtain the industry’s recognition and praise. Hence, BBC has been receiving more and more invitations from the companies to conduct in-house training. In addition to having a stronger course direction and more applicants per training course, a significant advantage of in-house training is that BBC can provide the enterprises with advice on how to resolve practical questions and encounters during training. On the basis of in-house trainings, BBC has already collaborated with several companies in different projects, such as the U.S. FDA application and cGMP compliance projects, helping them eventually achieve their target of exporting finished products to the U.S. market.

In order to coordinate the current training service pattern of “in-house training as primary, open training as secondary”, our open training service model has undergone comparatively significant changes. As usual, we will list all of our open training courses, including detailed introduction, on our website. Recently altered, the dates will no longer be set in stone; Before deciding on a set course date, we ask for interested participants to first apply and sign up for their desired training course(s), providing us with a desired time frame they prefer/are available to take the course. After a course has been filled to a certain capacity, we will contact and coordinate with those who applied on a most suitable date for every applicant. It will not only benefit the applicant’s preference on his/her availability in this way, but will also be a convenient way for BBC to coordinate the training date(s) in accordance with a time frame least conflicting with all the applicants’ preferences.