Innerspace invites you to their event

PDA-Innerspace Webinar - “From FDA Warning Letter to Success: Transforming a Culture Through Training"

About this event

During the coming webinar, we will explore how a team turned a critical FDA warning into a growth opportunity. In August 2022, their site faced serious challenges, including rebuilding a workforce with little to no experience in aseptic practices, maintenance, and quality control. In response, they completely revamped their training and built a culture focused on iterative and continuous improvement throughout all processes.

The results speak for themselves: onboarding and qualification times in aseptic areas were cut by 55%, correct employee behavior improved by 12%, and batch capacity increased by 66%, significantly boosting manufacturing efficiency and revenue. In addition, the Operational Excellence University program trained over 100 personnel in lean manufacturing and complex problem solving. Those graduates of OEU went on to generate more than $3 million each year in site savings through process improvements.

Join Jacob Hughes (Bora Pharmaceuticals, previously Emergent BioSolutions) and Chuck Gagnon (Innerspace) on their detailed dive into the Operational Excellence University case.


Register now to learn from this great success story.


Agenda:

16:00 - 16:05 Welcoming and Speaker Introduction

16:05 - 16:45 Presentation

16:45 - 17:30 Q&A


Format:

The webinar will be held as a live online webinar. The audience will have the opportunity to react, ask questions and interact with polls throughout the webinar.

Hosted by

  • Guest speaker
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    Jacob Hughes Operational Excellence Senior Specialist @ Bora Pharmaceutical

    Jacob Hughes is a seasoned Project Manager and Continuous Improvement specialist with a strong background in chemical processing and manufacturing. He has extensive experience in systems development, project management, and leadership, driving operational efficiency and enhancing business intelligence. Jacob’s career includes leadership roles in several organizations, where he has spearheaded initiatives in Lean Manufacturing, Six Sigma, and process improvement, resulting in measurable gains in productivity and cost reduction. Currently serving as an Operational Excellence Senior Specialist at Bora Pharmaceuticals, Jacob holds a B.S. in Chemical Engineering from the University of Florida.

  • Guest speaker
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    Sabine Hartmann Manager Programs & Events @ PDA - Parenteral Drug Association

  • Guest speaker
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    Chuck Gagnon Key Account Manager @ Innerspace

    Chuck is an accomplished and results-driven sales leader with over 20 years of experience in key account management, business development, and sales strategy across diverse industries, including food processing, pharmaceuticals, and industrial sectors. He joined Innerspace early 2024 and is leading the US-Sales team.

  • Team member
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    Robin Thiedmann Marketing Manager @ Innerspace

Innerspace

Impactful Cleanroom Training

Innerspace helps leading pharmaceutical companies train and assess cleanroom personnel more effectively than before to prevent mistakes and reduce risk.

We offer a scalable and globally implementable cleanroom simulator for training operators.