Joanna Gallant is an experienced, solutions-driven quality professional with over 24 years of technical and operational experience within pharmaceutical, biotechnology, and medical device manufacturing environments. She is a training leader known for designing, developing and delivering strong, interactive and effective GxP/ISO-related training.
Joanna is passionate about quality, problem solving, continuous improvement, and personal responsibility and accountability. Over her career, she has provided regulatory, technical, skill, and management development training support to all operations functions, as well as IT, R&D, customer service, and senior management.
Upcoming & Recent Speaking Engagements
Joanna will be giving a “Master Series” session on training game design at the 2018 GMP TEA Biennial Conference in October 2017. Visit the GMP TEA website for conference details and registration information
Recent speaking engagements include:
Ongoing schedule of webinars for Life Science Training Institute, adding more new GMP/quality system topics (US vs EU GMP; FDA’s Quality Agreement, Process Validation & Aseptic Processing guidances; new human error content, etc.)
Presented a session on Data Integrity at the 2017 LTEN conference
Continued delivery of webinars for Life Science Training Institute, adding more new GMP/quality system topics (powering up GMP training, role & competency based training development/implementation, final Quality Metrics guidance, etc.) in addition to continuing/updating existing courses
Presented “Reacting to Human Error: Moving Beyond “Retraining” as a Response” as a concurrent session at the June 2016 LTEN Annual Conference in the first ever offering of the “Discovery to Commercialization” conference track.
Delivered the first-ever quality training for a startup genetic therapy company heading into safety assessment studies and preparing GMP systems, covering current pharmaceutical quality system paradigm, GLP/GMP requirements and expectations of management.
Delivered a specially-designed webinar for a company manufacturing sterile/aseptic bio/pharmaceutical products on the why’s behind cleanroom behaviors and aseptic techniques with a 2 week turnaround from course development to delivery.
Delivered multiple training sessions for a client’s newly hired staff on the role of the individual in developing a quality culture
Delivered webinars for Life Science Training Institute, adding multiple new GMP/quality system topics (laboratory OOS expectations, preparing staff for regulatory inspections, training effectiveness, reacting to human error, preparing staff for aseptic processing, etc.)
Presented two well-received sessions at the 2015 GMP TEA Biennial Training Conference: “Telling the Tale: What Recent Inspection Observations Can Tell Us About Training System Expectations” and”Happy Endings: Make Your Smile Sheets Sing!”
Invited to speak on GMP inspection trends for a GMP TEA chapter relaunch meeting
Contracted to provide three training courses (Basic GMP, Management GMP, GLP) for a new client
Contracted to provide special, last-minute private offering of ICH Q8, Q9, Q10 webinar to a global clinical quality meeting – delivered with 2 hours notice, exceeding client expectations
Delivered webinars for Life Science Training Institute, on multiple GMP/quality system topics (FDA/EMA inspection & enforcement trends, data integrity, quality agreements, trainer qualification, effective training systems, SOP authoring/implementation, root cause analysis/CAPA)
Multiple training sessions for a client on the role of the individual in developing a quality culture
Delivery of a GMP Refresher session to management staff, obtaining attendee perspectives of where the company was at risk
Data Integrity & Good Documentation Practices training to a site of 600 people to address FDA inspectional observations
Recap of the FDA keynote presentation from the 2013 GMP TEA conference
Provided a two-hour workshop on immersive training design as an invited Master Class Speaker, and a one hour session on ICH Q8,9,& 10 at the 2013 GMP TEA Biennial Training Conference
Three different GMP refresher courses for clients
A primer on competency based training development and implementation as featured speaker at a global training meeting
An interactive session on common international regulatory citings and alignment to ICH Q10
Adjunct professor in the Boston University School of Medicine, providing a full-semester 4-credit course on cGMP & Quality Assurance
Invited annually as a guest lecturer, to provide an intro to US drug regulation & enforcement to Boston University BLCS students
Basic GMP, enforcement and quality topics in the WPI Biomanufacturing Certificate Program
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Joanna is very down-to-earth and speaks to you and with you, not at you.
Your hard work will pay enormous dividends, as we are now much better positioned to execute our training strategy and improve our compliance position.
Joanna has done an outstanding job of building the site’s Development & Training Team and advancing all the site’s learning and development needs.
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.
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.
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’ve attended similar programs over the years at 10 different companies – yours was easily the best and much more engaging than any other.
Emphasized that investigations should focus on HOW problem occurred and prevention.
Great course, excellent presentations, high energy presenter. Exceeded my expectations – thanks for a great GMP course!
I can’t say enough about Joanna – how do you maintain this high level of enthusiasm for each class?
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.
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.
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!
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.
Joanna is one of the best GMP instructors around, if not the best.
Instructor was very eloquent and highly knowledgeable on the subject, but was also entertaining.
The session increased my awareness surrounding patient safety and made me realize how much difference one voice/one person can make!
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 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.