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

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This webinar 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 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 OEU graduates generated 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.

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ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. [email protected]

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

Day 1

Thursday, 17 October 2024

Moderator: Robin Thiedmann, Innerspace

16:00 - 16:05 Welcoming and Speaker Introduction

16:05 - 16:45 Presentation by Jacob Hughes, Bora Pharmaceuticals

16:45 - 17:30 Q&A with Jacob Hughes, Bora Pharmaceuticals & Chuck Gagnon, Innerspace

 

Agenda is subject to change.

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