Dr Rainer Gnibl
GMP Inspector
Referent:innen
Dr Panagiotis Fakitsas
F. Hoffmann-La Roche
Dr Georg Sindelar
Recipharm
Hans Steier
Vetter Pharma-Fertigung
Dr Alexander Pontius
Bayer, Norway
Dr Frank Seibel
Roche Diagnostics
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.
Zielsetzung
This 2-day Master Class 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 help you turn your company’s quality excellence goals into reality.
Background
The US 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 problem in the industry. On the other hand, FDA’s Guidance 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 management elements are fully integrated and interconnected.
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.
This course explores the issues that can affect the ability of management to detect the warning signals of significant cGMP compliance problems and offers suggestions on how to gain control over this essential part of the Business.
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.
This course explores the issues that can affect the ability of management to detect the warning signals of significant cGMP compliance problems and offers suggestions on how to gain control over this essential part of the Business.
Programm
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 inspector‘s 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
- How the FDA defines Quality Oversight and what FDA expects from management and the Quality Control Units (QCU)
- Where to find expectations and requirements: 21 CFR 210 and 211, rules and guidance, Warning Letters etc.
- Typical problems FDA sees
- How the industry in the U.S. is dealing with this approach
Quality Oversight – Motor in a Multinational Company
- Implementation of a successful Quality Oversight strategy and program
- The role of the Quality Assurance Department
- Definition of critical processes and integration of a management control and reporting System
- Management of significant cGMP internal compliance problems and of a “warning system”
- One company with various sites: how to keep quality oversight
- The link to continuous improvement
Quality Oversight – the Effective Arm in your Transfer and CMO Business
- Best practise - designing and integrating Quality Oversight in transfer and Outsourcing
- Risk management and quality system oversight in the third party manufacturing Network
- How to deal with the various quality and documentation systems at different CMOs
- How to evaluate CMO Performance
Workshop: Performance Review and Monitoring
- Approaches to selecting and calculating KPIs
- Inputs / Outputs
- Meetings und Reports
- Aggregation for higher Management Oversight
Case Studies:
(1) Pharma Quality System: from Compliance Check to Quality Oversight (how to get there)
In this case study you will see how a pharmaceutical Company has gone through the transition from a fragmented Quality System to integrated Quality Oversight processes.
- Elements of an integrated QMS oversight concept
- How to implement effective and efficient review Systems
- Quality and Management Systems to lead the way to Quality Oversight
- The use of Quality Metrics
- Lessons learned
(2) 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
(3) Case Study Roche: The Quality Product Leader Model
- How a Quality Product Leader acts as a single point of contact for consistent end-to-end product Quality oversight and continuous improvement
- Monthly Product Quality Report
- Annual Product Quality Plan
(4) Oversight at a small Manufacturing Site
- Managing Quality Oversight by a small Company-internal Quality Unit in a Complex CMO Network
(5) Quality Oversight in Times of digital Transformation
- Dashboarding and Real Time Trending
- Prospective Quality Oversight
- Links to Knowledge Management and Artificial Intelligence (AI)
Weitere Informationen
Venue
Radisson Blu Scandinavia Hotel
Amager Boulevard 70
2300 Copenhagen S
Denmark
+45 (0)33 96 50 00
Radisson Blu Scandinavia Hotel
Amager Boulevard 70
2300 Copenhagen S
Denmark
+45 (0)33 96 50 00
Accommodation
CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.
CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.
Fees (per delegate, plus VAT)
ECA Members € 1,890
APIC Members € 1,990
Non-ECA Members € 2,090
EU GMP Inspectorates € 1,045
The conference fee is payable in advance after receipt of invoice and includes conference documentation, dinner on the first day, lunch on both days and all refreshments. VAT is reclaimable.
ECA Members € 1,890
APIC Members € 1,990
Non-ECA Members € 2,090
EU GMP Inspectorates € 1,045
The conference fee is payable in advance after receipt of invoice and includes conference documentation, dinner on the first day, lunch on both days and all refreshments. VAT is reclaimable.
Social Event
In the evening of the first day, you are cordially invited to a social event. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
In the evening of the first day, you are cordially invited to a social event. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Presentations/Certificate
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site.
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site.
After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
Contacts
Questions regarding content please contact:
Mr Wolfgang Schmitt, +49 (0)6221 84 44 39, w.schmitt@concept-heidelberg.de
Questions regarding organisation:
Ms Isabell Helm, +49 (0)6221 84 44 49, helm@concept-heidelberg.de
Questions regarding content please contact:
Mr Wolfgang Schmitt, +49 (0)6221 84 44 39, w.schmitt@concept-heidelberg.de
Questions regarding organisation:
Ms Isabell Helm, +49 (0)6221 84 44 49, helm@concept-heidelberg.de
Datum & Uhrzeiten
Wed, 17 June 2026, 9–17:30 h
Thu, 18 June 2026, 8:30–15:30 h
Thu, 18 June 2026, 8:30–15:30 h
Teilnahmegebühr
| 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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