Joanna just completed an 18-month consulting assignment (she was extended twice by the client because of the quality of her work) to develop and implement a full GMP training system at a startup site working under a modified consent decree. As part of that project, she designed, delivered and implemented the site’s GMP training system procedures, an onboarding program, in-depth GMP subpart training, an OJT program with performance assessments and provided rollout support to the functional areas as they implemented the OJT program, and provided direction and support as the company headquarters rolled out a global LMS, as well as mentoring training and other personnel in the facilities. This system underwent FDA inspection at the client site in 2016 with no issues, and was presented as the remediation to a 483 observation on training at a second, established facility in 2017. The client subsequently decided to implement the training system procedures and content globally. Job well done, we’d say…
Links to Joanna’s articles for Pharmaceutical Online are available on the Articles & Posts page – more added as they’re published. Many of Joanna’s articles make Pharmaceutical Online‘s Top 10 Most Read lists each year – see them for yourself! We’ve also converted a variety of Joanna’s earlier articles into whitepapers, available as free downloads through our store.
Joanna recently had the opportunity to provide an in-depth training course to an IVD manufacturer in the UK, and used the QSR version of “You Bet!” to provide a high energy review to end the course – and the attendees LOVED it! Visit our online store to see this and our other available games & puzzles – we’ll be adding more regularly!
Joanna was slated to deliver a Master Series session on training game design, and a session on instructional design at the 2017 GMP TEA Biennial Training Conference – which, due to Hurricane Irma, has been postponed to October 2018. Visit the GMP TEA website for conference details and registration information!
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 helped set the direction and established many key processes including the foundation for an onboarding program that is becoming the global standard for our company.
I liked the way Joanna went over the process/sequence of events and how we should approach problems should they occur.
The session increased my awareness surrounding patient safety and made me realize how much difference one voice/one person can make!
You are truly a great GMP trainer. Your understanding of the content combined with the talent to make the subject easy to understand is a very rare combination. You have helped the people in this company in ways that they have yet to understand.
One of the best programs I’ve attended – I have been to many different training programs and the worst was said to be GMP – this course has proven that wrong!
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.
What a privilege to have been able to work with you! You are truly amazing. I love your combination of integrity, honesty, and professionalism and I will choose to be different because of what I have learned working with you.
We have a new corporate standard for training – Joanna!
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.
Thanks for being SO easy to work with – wish all consultants could be like you!
You spoke in terms of ‘we’, not ‘you’ – this was important for the content.
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.
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.
Joanna sets the standard for webinars.
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.
Instructor was very eloquent and highly knowledgeable on the subject, but was also entertaining.
The information you provided could influence the direction we take to validate systems and enforce our own compliance.
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!
You are very energetic and your knowledge is very broad-based. Your enthusiasm was infectious!