About Joanna Gallant
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Joanna Gallant is an experienced, solutions-driven, quality professional with almost 30 years of technical and operational experience within the 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, and continuous improvement, as well as 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.
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Annual Highlights
2023:
2022:
2021:
- Contracted to develop and deliver virtual ILT for GMP management development workshops
- Contracted to deliver remote ILT GMP training course - the first ever! - for an ERP computer system provider
2020 highlights:
- Delivery of webinars for Life Science Training Institute on quality, training and human error topics until their absorption into another company
2019 highlights:
- Ongoing delivery of webinars for Life Science Training Institute on quality, training, and human error topics
2018 highlights:
- Ongoing delivery of webinars for Life Science Training Institute on quality, training, and human error topics
- Provided a 2-hour Master Series session on game design, along with a concurrent session on instructional design at the 2018 GMP TEA Biennial Training Conference. Delivered a concurrent session on Reacting to Human Error on short notice, when asked to fill in as an emergency replacement for another speaker.
- Designed/delivered for new clients:
- An SOP Authoring course/workshop (large multinational/GXP company, NJ)
- 2-day GMP course (API manufacturer, NC)
- Initial GMP training for virtual company on FDA fast-track approval (drug company, NC)
- Full day regulatory inspection preparation course (generic drug client, NJ)
- 2-day deviation/investigation/root cause analysis course (device client, CA)
- Full day medical device GMP/regulatory inspection course for quality personnel (major GXP supplier client, MA)
- Full day GMP refresher course (generic drug client, RI)
- Initial GMP training for startup company initiating clinical trials (drug client, MA)
2017 highlights:
- Continued delivery of webinars for Life Science Training Institute, adding more new GMP/quality system topics (U.S. vs EU GMP; FDA’s Quality Agreement, Process Validation, and Aseptic Processing guidances; new human error content, etc.)
- Presented a 2-day course on medical device regulations (QSR & ISO 13485:2016) to an IVD company in the U.K.
- Presented a 2-1/2 day course on pharmaceutical, device, and combination product regulations, and quality systems for a Mexican company’s startup site
- Delivered a full day training course covering GMP refresher, human error prevention, and data integrity content for company manufacturing including clinical study materials
- Delivered new hire training for existing clients, including two preparing for NDA/MAA submission PAI’s
- Was invited to present a session on Data Integrity at the 2017 LTEN conference
2016 highlights:
- Continued delivery of webinars for the Life Science Training Institute, adding more new CMP GMP/ quality system topics (powering up GMP training, role, and competency based training development/ implementation, final Quality Metrics guidance, etc.), in addition to continuing and 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
2015 highlights:
- Delivered webinars for the 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 a 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
2014 highlights:
- Delivered webinars for the Life Science Training Institute, on multiple GMP/quality system topics (FDA/EMA inspection and 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 and 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
2013 highlights:
- Provided a two-hour workshop on immersive training design as an invited Master Class Speaker, and a one hour session on ICH Q8,9,and 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