We had a great year in 2016! In April, 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, 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 Joanna’s training system, procedures and personnel training for the site, and found no issues! Huge congratulations to our client – awesome job done by all!
And we’re still hearing rave reviews for Joanna’s webinars through LSTI. A list of currently scheduled courses is available in our list of upcoming speaking engagements.
Joanna will be providing a public offering session of CGMP for Pharmaceutical Lifecycle Management, through the Center for Professional Advancement (CfPA) in New Brunswick, NJ from March 20-22 – visit the CfPA’s course site to find out more and to register for the course.
Additionally, Joanna has been 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 other articles Joanna has written this year on the Articles & Posts page.
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! (coming soon). 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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Thanks for the great effort and outstanding results you have already facilitated by getting these groups to work together.
You have done it – you’ve found a way to make refresher interesting. Congratulations!
Your outstanding presentation was both informative and entertaining. Thank you so much for sharing your time and experiences with us!
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.
You spoke in terms of ‘we’, not ‘you’ – this was important for the content.
Emphasized that investigations should focus on HOW problem occurred and prevention.
I liked the way Joanna went over the process/sequence of events and how we should approach problems should they occur.
Instructor was very eloquent and highly knowledgeable on the subject, but was also entertaining.
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.
Your presentation got me excited about GMPs – which I won’t admit to too many people!
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.
I’ve attended similar programs over the years at 10 different companies – yours was easily the best and much more engaging than any other.
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!
Your project is something that can be studied by the company and used as a model for future change.
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 session increased my awareness surrounding patient safety and made me realize how much difference one voice/one person can make!
Thanks for being SO easy to work with – wish all consultants could be like you!
You have an impressive skill set and an ability to bring clarity out of confusion.
You did a great job keeping things on track, but still allowing discussion and questions.
Great job in pulling together lots of details. Thanks for assembling a complex report so quickly and so well.