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.
And we’re still hearing rave reviews for Joanna’s webinars through LSTI. A list of currently scheduled courses – which includes three new sessions on the FDA’s finalized Quality Agreement guidance, a comparison of the US & EU GMP expectations, and a followup to her popular human error course – 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?
Subscribe to Our Newsletter!
Our periodic newsletter includes information on newly released products and articles, regulatory updates, hints, tips, and the newsletter-only
"GMP Training Tips & Tools"!
Loading - Please wait
You have an impressive skill set and an ability to bring clarity out of confusion.
You spoke in terms of ‘we’, not ‘you’ – this was important for the content.
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.
Joanna is the complete package – she can do it all. From the day-to-day detail work to identifying improvement needs and developing strategy for the future, designing and delivering training to planning LMS upgrades and the associated validation work – if I need it, she can do it, and do it well. She’s one of a kind!
I liked the way Joanna went over the process/sequence of events and how we should approach problems should they occur.
Emphasized that investigations should focus on HOW problem occurred and prevention.
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.
Thanks for the great effort and outstanding results you have already facilitated by getting these groups to work together.
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.
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.
I can’t say enough about Joanna – how do you maintain this high level of enthusiasm for each class?
This team was a great example of working together, cross functionally, to achieve a goal. We have a complete URS for the LMS, and a foundation at all of the sites to build upon. This team was a key enabler to make this a reality and we learnt much from this.
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.
Fantastic job – people are saying yours was the best webinar they’ve attended in years. Universally outstanding feedback! Clearly you know what’s going on and you have your finger on the pulse of the industry.
Joanna is very down-to-earth and speaks to you and with you, not at you.
Thanks for being SO easy to work with – wish all consultants could be like you!
Everything was covered with real life examples. There was a lot to digest, but variety and mixing it up with activities kept it from getting boring, and it was able to keep my interest and attention. The informal approach made it relaxed and easier to learn.
Your hard work will pay enormous dividends, as we are now much better positioned to execute our training strategy and improve our compliance position.
Your outstanding presentation was both informative and entertaining. Thank you so much for sharing your time and experiences with us!
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.