Right-sizing GMP and Compliance

13/14 March 2025, Barcelona, Spain

Course No. 21671

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Speakers

Dr Anke von Harpe

Dr Anke von Harpe

QProgress

Cecilie Hejlskov

Cecilie Hejlskov

Syntese

Arnoud Herremans

Arnoud Herremans

Lean Kaizen Consultant

Dr Frank Seibel

Dr Frank Seibel

Roche Diagnostics

Christof Langer

Christof Langer

OSConsulting

Objectives

Learn how to design lean, efficient and compliant Quality and GMP-Systems that will support you in turning your quality goals into reality.

Background

Good Manufacturing Practices (GMP) in the pharmaceutical industry are designed to ensure that products are consistently produced and controlled according to defined quality standards. However, some companies tend to overinterpret regulations, leading to unnecessary processes that can inflate costs and reduce efficiency. To right-size GMP and compliance, and move towards lean GMP-systems while still adhering to regulations and being compliant, companies can consider several strategies and use various tools. By focusing on these, companies can develop lean GMP-systems that are not only compliant but also optimised for efficiency and effectiveness. It's about finding the right balance between ensuring product quality and safety while eliminating unnecessary costs and processes.

Target Group

Managers and Executives from pharmaceutical Quality Management and Assurance, Business Executives and Production Managers and those involved in continuous improvement projects.

Programme

Right-sizing GMP and Compliance

Seminar Programme as PDF

Less is more: Insights from continuous Improvement to bring GMP to the Size you need
  • What does lean thinking mean (and what does non-lean thinking mean)?
  • Role of Quality functions
  • Customer value
  • Examples for problem solving Tools
  • Continuous improvement
Lean Process Management: Case Studies & Template Tools
  • PfC Analysis
  • Process Competent Assessment
  • Effectiveness Check
  • Templates
Linking Lean and Quality
  • Using Lean Thinking for Improvements in the Quality Management System (QMS)
  • Potential Target Areas of Lean
  • QC Backlog
    - Timely deviation closure
    - Batch Record Review
    - “Non Make/Assess/Release”- Areas
    - Lean leadership
Interactive Sessions:
Coaching and Mentoring your People towards better GMP Improvements
Learn and discuss the A3 lean thinking approach as a learning practice, problem solving tool and knowledge sharing.

Lean Process Management: Workshop with Theory and Group Excersises
Learn to manage your quality processes in a practical and lean way through an interactive workshop with theory and group exercises.

Right-sizing GMP and Compliance
  • The ‘What’ vs the ‘How’ - what is the right ratio?
  • How to apply ‘Ensuring’ and ‘Controlling’ in a balanced manner
  • The ‘7 deadly sins’ of right-sized compliance
  • Ways to implement
Lean (Documentation) Systems
  • Background
  • Tools and structural elements for efficient GMP documents
  • Training – how to ensure the right level for each role
  • Case study: Batch Record Review to the point
Kaizen as a Powerful Tool for Optimisation of Complex Processes
  • Does the system fit to the company?
  • Methods for determining needs and finding Solutions
  • Customer-oriented project planning as a central success factor
Using LEAN Thinking for Improvements in the Quality Management System (QMS)
  • Experiences in using LEAN/Six sigma methodology for QMS improvements
  • Examples of process simplifications
  • Deep dive in creating a LEAN CAPA process

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This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager" Learn more

ECA-Member*: € 1690,-
Non ECA Member*: € 1890,-
EU/GMP Inspectorates*: € 945,-
APIC Member Discount*: € 1790,-

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
American Express Visa Mastercard

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Further dates on-site
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Recording
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Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

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Testimonials about our courses and conferences

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023

 

“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024

 

“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024

 

 

“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
Live Online Training – QP Education Course Module A, November 2023