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

Online
Ask a Question Exhibitor Standard Contract Clause

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!

Contact

Program Inquiries
Sabine Hartmann
Exhibition/Sponsorship Inquiries
Christopher Haertig
Training Course Inquiries
Christopher Haertig
training-europe@pda.org
Registration Customer Care

Standard Registration

Member Price

Complimentary

GovernmentMember Only

Complimentary

Health AuthorityMember Only

Complimentary

Early Career ProfessionalMember Only

Complimentary

StudentMember Only

Complimentary

AcademicMember Only

Complimentary

Non-Member

Complimentary

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. registration-europe@pda.org

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 registration-europe@pda.org 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

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

Agenda is subject to change.

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.


Online, ,