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2023 PDA How to Meet the Regulator’s Expectation for cGMP Compliant Training

Oct 09, 2023
2:30 PM
-
4:00 PM
| Central Europe Standard Time
Online
  • Virtual
  • Webinar
  • Online
  • Europe

Overview

Dear Colleagues,

We'd like to invite you to our upcoming webinar about "Meeting Regulatory Requirements for cGMP-Compliant Training". The session is divided into two parts:

Part 1: How Human Factors Influence Inspection Outcomes – Insights From a Former Inspector

In this first segment, we'll be taking a look at how human factors influence inspection outcomes. Tracy Moore, an accomplished quality professional with over 32-year experience in pharmaceutical manufacturing, will share valuable insights gained from her role as a former inspector. Explore how culture, human factors, and training all play a role in achieving successful inspections. Additionally, we will discuss some practical tools and techniques designed to mitigate human errors and offer recommendations based on real inspection findings.

Part 2: Myths in Training – Insights From a Trainer's Perspective on How Training Transfer to Manufacturing Can Succeed

In the second part of our webinar, we encourage you to challenge some common misconceptions in training. By questioning the idea that training should always cover the same content and focus exclusively on processes, our training expert, Sebastian Scheler, will provide valuable insights on how to effectively transfer training to the manufacturing sector. Additionally, a showcase of real-world case studies will highlight the possible advantages of using immersive technologies for training.

We look forward to your participation!

Agenda

  • 14:30 – 14:40
    Welcome and Introduction


    14:40 – 15:30
    Part 1: How Human Factors Influence Inspection Outcomes – Insights From a Former Inspector

    • Understanding the inspection goal regarding culture, human factors & training
    • Different aspects to minimize human error: Tools and techniques for effective human error reduction
    • Insights and findings from inspections – recommendations, practical advice and pitfalls to avoid

    Presenter: Tracy Moore, TM Pharma Group


    15:30 – 16:00
    Part 2: Myths in Training - Insights from a Trainer's Perspective on How Training Transfer to Manufacturing Can Succeed

    "Every training should always cover the same content" – How to find meaningful standardization categories in training development.

    "Training should just focus on our processes" – How to define learning objectives that cover both fundamentals and process-specific knowledge and skills.

    "Immersive technology is not mature enough" – Case-Studies on successful implementation and advantages of VR simulators.

    Presenter: Sebastian Scheler, Innerspace


    16:00 – 16:30
    Poll Questions and Q&A

Highlighted Speakers

Tracy Moore
Tracy Moore
TM Pharma Group Ltd
Sebastian Scheler
Sebastian Scheler
Innerspace GmbH

Registration Fees

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Registration Type Price
All Participants Complimentary

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