About Joanna Gallant

Joanna Gallant is an experienced, solutions-driven quality professional with over 25 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.

Download a short biography of Joanna or visit Joanna’s LinkedIn profile.


Upcoming & Recent Speaking Engagements

Joanna will be giving a “Master Series” session on training game design at the 2018 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!

Recent speaking engagements include:

2018:

Ongoing delivery of webinars for Life Science Training Institute – upcoming sessions include:

Instructional Design for GMP Training – Improve Effectiveness and Measurability – April 24, 2018

New course! Measuring CAPA Effectiveness: Critical Tips in Getting the Right CAPA and Showing It Works – April 25, 2018 (link posted when available)

Root Cause Analysis & CAPA Identification: A Step-by-Step Guide – May 15, 2018

New course! FDA’s Guidance for Industry, “Process Validation: General Principles & Practices” – or, Whatever Happened to IQ, OQ, PQ? – May 16, 2018 (link posted when available)

Designed/delivered an SOP Authoring course/workshop for a new client in NJ

Delivered a 2-day GMP course for a new client in NC

2017 highlights:

Continued delivery 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 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 pharma, device and combination product regulations and quality systems for a Mexican company’s startup site

Delivered full day training course covering GMP refresher, human error prevention and data integrity content for company manufacturing clinical study materials

Delivered new hire training for existing clients, including two preparing for NDA/MAA submission PAI’s

Presented a session on Data Integrity at the 2017 LTEN conference

2016 highlights:

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

2015 highlights:

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

2014 highlights:

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

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,& 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

Academic Institutions:

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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