The FDA Enters Education E-Style

Written by Nancy Tomoney - Associate Validation Manager, QPharma

The FDA, in its process improvement program, is enhancing education for companies and consumers on the FDA website, www.FDA.gov.

CDRH is the first center to add course material at CDRH Learn, www.fda.gov/Training/CDRHLearn.  Most material is available in three languages: English, Spanish and Chinese.  Courses offered are in most medical device regulations, regulated software, BIMO and the 510K process.  The e-learning posted represents the areas that lead in lack of compliance for medical device folks with the code of federal regulations.  Most educational courses that are currently listed are focused on the health care industry, manufacturers and clinicians.

For those of use seeking to enhance our knowledge on regulations, it represents a good starting point.  However, it will not stop the foolish manufacturers who continue to rack up 483s, Warning Letters and other noncompliance notifications by willful violation.  It may assist the unwitting violator, who broke the regulations because they were unclear or unlearned.  The courses do not replace annual site training in the good manufacturing practices.

Can we guess why FDA has done this? We shouldn't have to.  Over the last two decades, many companies have reduced their budgets for employee education.  This has become evident by the fall-off in professional conference attendance.  Companies don't have the time to train employees in groups on site, and conference costs continue to rise. A company may send one employee to a conference and expect them to return to the site and train others. - a common practice that often falls short in follow-through and substance.  Trying to bring a conference on-site also becomes expensive.

QPharma offers both Lunch & Learns and customized onsite training, as well as compliant e-Learning for the entire organization.  Lunch & Learns consist of one hour programs on hot button FDA topics; never a sales pitch and as the name states, lunch is on us.  Customized training solutions are offered on a fee basis.  They represent truly site specific training.  They are more detailed, transparent to the client’s own education platforms and tailored for the client site’s processes.  They represent better value as the instructor is not lecturing to a mixed audience, but a group with specific needs; and since CDRH is the only FDA center offering e-learning, QPharma can supply your needs from specifics on the other centers, such as CDER, CVM and CBER. We take education seriously, considering the environment we come from!