Dr Rainer Gnibl
GMP Inspector
Referent:innen
Dr Panagiotis Fakitsas
F. Hoffmann-La Roche
Dr Georg Sindelar
Bayer
Hans Steier
Vetter Pharma-Fertigung
Dr Alexander Pontius
Bayer, Norway
Dr Frank Seibel
Roche Diagnostics
All times mentioned are CEST.
Zielsetzung
This 2-day Live Online Training brings together well-experienced experts to discuss the latest expectations and best practices for effective and efficient Quality Oversight processes and how to get there. This will support you turning your company’s quality excellence goals into reality.
Hintergrund
The U.S. Food and Drug Administration FDA frequently criticises pharmaceutical companies for not having sufficient “Quality Oversight“ on their operations and processes. The number of pharmaceutical companies that have received FDA 483s and Warning Letters indicates that management oversight of current good manufacturing practice (cGMP) compliance is a significant and continuing challenge for the industry. On the other hand, FDA’s Gui-dance for Industry on Quality System Approach to Pharmaceutical cGMP, ICH Q9 and Q10 and EU-GMP Guide Chapter 1 have been introducing a new way of quality thinking to the pharmaceutical industry. It is now expected that the various quality systems and quality management elements are integrated and linked.
Aside from being the thesis of major FDA enforcement actions, compliance to GMP regulations is, in fact, a part of normal pharmaceutical business that requires diligent management oversight. Just as it is with other business areas, management has the responsibility to ensure that systems are in place to effectively monitor the state of control in order to intervene with timely decisions to manage risk, achieve goals, and add stakeholder value. It is of utmost importance to detect and heed possible problems early enough.
Aside from being the thesis of major FDA enforcement actions, compliance to GMP regulations is, in fact, a part of normal pharmaceutical business that requires diligent management oversight. Just as it is with other business areas, management has the responsibility to ensure that systems are in place to effectively monitor the state of control in order to intervene with timely decisions to manage risk, achieve goals, and add stakeholder value. It is of utmost importance to detect and heed possible problems early enough.
Zielgruppe
Managers and Executives from pharmaceutical Quality Units but also Senior Management, Business Executives and Production Managers and those involved in improving the Pharmaceutical Quality System.
Date & Technical Requirements
Date
Tuesday, 27 May 2025, 9.00h – 16.15h
Wednesday, 28 May 2025, 8.30h – 16.30h
All times mentioned are CEST.
Technical Requirements
We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programm
Gesamtes Programm als PDF herunterladen
Quality Oversight in the View of an EMA Inspector
- What does Quality Oversight mean in the EU?
- The Basis: Pharmaceutical Quality Systems (PQS)
- Which are the essential PQS-elements?
- QA Management of PQS and the benefit from an inspectors point of view
- Inspectors‘ expectations on EU Quality Oversight
- How to synchronize EU with US?
- EU answer to US-FDAs “Quality Metrics Guideline”
- Which approach makes sense from various experience in inspections?
Current FDA Expectations and future Developments
- Quality Reviews in USA (Overview)
- QA-Department´s Responsibilities in USA
- US-FDA Findings on Quality Oversight
- US-FDA Findings on Management Oversight
- US-FDA „Quality Metrics“-Guideline
- EU-Equivalent to US-FDA´s „Quality Metrics”
Quality Oversight – the Engine in a Multinational Company
- Definition of Quality Oversight
- Elements
- Levels
- Implementation
Pharma Quality System: from Compliance Check to Quality Oversight (how to get you there) – a Case Study in three Steps
In this case study you will see how a multinational pharmaceutical company has gone through the transition from a fragmented Quality System to integrated Quality Oversight processes.
Part 1: Starting Point
Part 1: Starting Point
- The Warning Letter
- GAP Analysis
Part 2: Implementation Phase
- How to establish an appropriate meeting culture
- What we can learn from ISO
- The need to restructure quality departments
- How to implement effective and efficient review systems
- Quality and Management Systems to lead the way to Quality Oversight
Part 3: Performance Review and Monitoring
- The use of Quality Metrics
- Feedback loops
- Lessons learned
Case Study Roche: The Quality Product Leader (QPL) Model
- How a Quality Product Leader acts as a single point of contact for consistent end-to-end product quality oversight and continuous improvement
- Development of the Model
Quality Oversight – the effective Arm in your Transfer and CMO Business
- Design of a Transfer
- Risk Management and Quality Oversight
- The Role of the QTA
- Performance Evaluation
Case Study Vetter Pharma-Fertigung: Quality Oversight in a CMO Business (Sterile Manufacturing)
- Establishing a Quality Oversight system at a contract manufacturer
- Interfaces to other Systems
- How it was seen by FDA
- Person in the Plant Concept: advantages and challenges
Case Study: Quality Oversight at a small Manufacturing Site
- Quality Oversight in Times of digital Transformation
- Dashboarding and Real Time Trending
- Prospective Quality Oversight
- Links to Knowledge Management and Artificial Intelligence (AI)
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager"
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E-Mail: info@concept-heidelberg.de
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