In April 2016, Joanna took on a challenging consulting assignment to develop and implement a full GMP training system at a startup company working under a modified consent decree. In November 2016, the FDA approved the site after performing an inspection that yielded NO 483 observations! During that process, 2 ex-FDA and 3 current FDA investigators looked at the training system, procedures and personnel training for the site, and found no issues! Huge congratulations to our client – awesome job done by all! – And in early 2017, the client decided to implement Joanna’s GMP training system across all three of their finished product manufacturing facilities globally. The same training system procedures are available in our online store, for those who may be interested.
And we’re still hearing rave reviews for Joanna’s webinars through LSTI. A list of currently scheduled courses – which includes new sessions, including a comparison of the US & EU GMP expectations, a followup to her popular human error course and forthcoming courses reviewing the FDA’s Process Validation & Aseptic Processing Guidances – is available in our list of upcoming speaking engagements.
Additionally, Joanna was approached and asked to provide a session on data integrity expectations at the 2017 LTEN Annual Conference in June 2017. Visit the LTEN Annual Conference website for conference information.
And, Joanna will be giving a “Master Series” session on training game design at the 2017 GMP TEA Biennial Conference in September 2017. Visit the GMP TEA website for conference details and registration information
Another one of Joanna’s articles made Pharmaceutical Online‘s top 10 most read list for 2016 – “The 5 Basic Tenets Of Data Integrity — And How Failures Occur” was the #5 most read article for the year! See this and Joanna’s other articles on the Articles & Posts page – more added as they’re published.
In what little free time we’ve had, we’ve been working on a new addition to our drug & device training games & puzzles – a 21CFR 210 & 211 version of “You Bet!”. Visit our online store to see this and our other available games & puzzles – we’ll be adding more regularly!
We’ll be sending our next “GMP Training Tips & Tools” newsletter shortly. Sign up for future issues using the widget on the right side of the screen so you don’t miss future training tips & tools!
Please get in touch if we can assist your organization — use our contact form or call us to let us know how we can help you!
What Do We Do?
JGTA, LLC is a consulting business focused on GMP-related training in the pharmaceutical, medical device and biotechnology industries, in compliance with US and international regulatory requirements.
Our ultimate goal is to ensure your personnel are prepared and able to perform GMP tasks with the appropriate levels of knowledge and skills.
Functions/services we provide include:
Our sample projects list provides examples of some of our consulting projects.
How can we help you today?
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The session increased my awareness surrounding patient safety and made me realize how much difference one voice/one person can make!
I’ve attended similar programs over the years at 10 different companies – yours was easily the best and much more engaging than any other.
You have an impressive skill set and an ability to bring clarity out of confusion.
Your hard work will pay enormous dividends, as we are now much better positioned to execute our training strategy and improve our compliance position.
I have to say thank you – our client took a class of yours on training systems, and they have used a lot of your principles – thanks to you, they have a good foundation, which has made this project easier.
I attended your Root Cause Analysis & CAPA Identification webinar on 12-Nov-2014. As a result, we are planning on overhauling our entire non-conformance system to incorporate some of the valuable information we learned in your seminar.
You are very energetic and your knowledge is very broad-based. Your enthusiasm was infectious!
The way this class was put together caused us to review GMP activities that needed to be reviewed, but the review was very entertaining and the game format made us try very hard to understand the content to win the game. It is by far the best refresher I have attended, both for learning and wanting to participate – it really made us think hard!
The instructor presented real life examples which were easy to relate in our own jobs. The course enabled us to review the areas where the FDA finds most issues to verify that we are in compliance.
In all my years of seeing various different GMP training courses, yours demonstrate the best overall grasp of GMP and what it means on the floor and in practice.
Your outstanding presentation was both informative and entertaining. Thank you so much for sharing your time and experiences with us!
Thanks for your energy and focus to drive this process forward. I could not have anticipated just how complicated this change would be. You’ve done a terrific job of pulling lots of different people together to get them to solve a challenge that has been very costly.
The information you provided could influence the direction we take to validate systems and enforce our own compliance.
Most valuable part to me was the complete overview of why we must do certain things. I have been with the company for 28 years, and I knew WHAT we needed to do – now I know WHY.
Thanks for the great effort and outstanding results you have already facilitated by getting these groups to work together.
Great job in pulling together lots of details. Thanks for assembling a complex report so quickly and so well.
You did a great job keeping things on track, but still allowing discussion and questions.
To me, the most valuable part of the program was the teamwork in developing the answer – no one knew all the answers, and the teamwork make it easier and more fun to contribute. This was easily the best GMP program I’ve ever attended.
This was quite an animated presentation for such a difficult topic. Joanna, the passion you have for this topic shows through – one can only hope that others who pass through the class take that enthusiasm with them.
You spoke in terms of ‘we’, not ‘you’ – this was important for the content.