ARTICLES BY JOANNA

• Taking GMP Training From Painful To Practical

  11/4/2015

  For many, GMP training is an event where attendees are herded into a room and are read the contents of the regulations or asked to watch a video. This video is often the same slides or video year after year.  Then, after this nice little break, everyone goes back to their jobs, forgetting about it until the next time the necessary evil called “GMP training” is required.

• To CBT Or Not To CBT…It Shouldn't Be A Question

  4/15/2015

  Recently, a colleague sent me a question about whether performance assessments as part of training – verification of a trainee’s ability to perform a task in accordance with predefined criteria – were an industry standard. 

• What Management Skills Have The Most Impact On GMP Performance?

  2/12/2015

  Some think the most critical success element in a GMP environment is the technical knowledge of those who perform the tasks, lead, or make decisions. For those in leadership or management roles, it is important to possess technical strength, but there are additional skills they must also have in order to truly be successful. So what specific skills do managers and supervisors need to be successful in a GMP environment?

• Identifying cGMP Issues Caused By “Management Problems”

  12/8/2014

  When asking attendees of my root cause analysis webinars and courses about the root causes of cGMP issues, "Management Problems" are the least frequently identified issues by respondents while “Personnel Errors" are identified as the most. Do managers truly make so few errors in comparison, or are we not correctly identifying situations as “Management Problems” when they occur?

• Human Error Is The Leading Cause Of GMP Deviations – Or Is It?

  5/1/2014

  Think of your company’s deviations. Concentrate on their most common root cause – the one you see most often and have the hardest time fixing. My high-tech-mind-reading-helmet tells me your answer is human error, correct? Magicians aren’t supposed to reveal their tricks, but this one really isn’t much of a trick.  Every company wrestles with human error.  We know humans have error rates – we’re not perfect.  But how many is too many?

• Strong Data Is Generated By Strong People

  3/7/2014

  By Joanna Gallant, Joanna Gallant Training Associates

  In the event you’ve been living under a rock for the last several months, facility inspection information released by FDA has thrust data integrity into the spotlight.  As someone who had responsibility for assuring laboratory data quality in the past, I find the recent spate of issues reported in FDA warning letters and 483s to be extremely disconcerting. Each subsequent revelation becomes more unbelievable. The good news is that steps to ensure data integrity are completely within our control – assuming we will put the time into executing them. 

• The Road To A Culture Of Quality

  Lately, I’m having a lot of conversations about the culture of quality and continuous improvement.  While it seems like everyone wants a culture of quality, the problem seems to be that we don’t understand how to create it. The first piece is to understand the drivers.  Without them, the culture won’t change.  Even with them, achieving cultural change takes time and requires effort—it doesn’t just happen, you have to work at it.