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!
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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.
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Your presentation got me excited about GMPs – which I won’t admit to too many people!
You did a great job keeping things on track, but still allowing discussion and questions.
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.
Joanna sets the standard for webinars.
Instructor was very eloquent and highly knowledgeable on the subject, but was also entertaining.
Joanna is one of the best GMP instructors around, if not the best.
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.
I can’t say enough about Joanna – how do you maintain this high level of enthusiasm for each class?
You have an impressive skill set and an ability to bring clarity out of confusion.
Thanks for the great effort and outstanding results you have already facilitated by getting these groups to work together.
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.
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.
I liked the way Joanna went over the process/sequence of events and how we should approach problems should they occur.
Great course, excellent presentations, high energy presenter. Exceeded my expectations – thanks for a great GMP course!
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.
You have done it – you’ve found a way to make refresher interesting. Congratulations!
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.
The information you provided could influence the direction we take to validate systems and enforce our own compliance.
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.
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.