Dr Rainer Gnibl
GMP Inspector
Referierende
Dr Panagiotis Fakitsas
Senior Quality Product Leader
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
- Senior Management, Business Executives and Production Managers involved in improving the Pharmaceutical Quality System
Zielsetzung
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.
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 challenge for 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 quality management elements are integrated and linked.
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 challenge for 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 quality management elements are integrated and linked.
Programm
Highlights
- FDA and EU Expectations
- Managing Quality Oversight
- Case Studies
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: 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
- Managing Quality Oversight by a small Company-internal Quality Unit in a Complex CMO Network
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
Technical Requirements
Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
Fees (per delegate, plus VAT)
ECA Members EUR 1,890
QP Association Members EUR 1,890
APIC Members EUR 1,990
Non-ECA Members EUR 2,090
EU GMP Inspectorates EUR 1,045
The conference fee is payable in advance after receipt of invoice.
Presentations/Certificate
The presentations for this event will be available for you to download and print before and after the event. After the event, you will automatically receive your certificate of participation.
Conference Language
The official conference language will be English.
Contacts
Question regarding content:
Mr Wolfgang Schmitt,+49 6221 84 44-39, w.schmitt@concept-heidelberg.de
Questions regarding organisation:
Mr Max Bauer, +49 6221 84 44-25, bauer@concept-heidelberg.de
Participant Feedback from previous Courses:
„Overall the whole course was a very interesting topic and provided a lot of valuable information on Q-Oversight and I would always recommend this course to others - to colleagues interested in Q-Oversight.”, Stefan Trentmann, DAIICHI SANKYO Europe GmbH, Germany
Datum & Uhrzeiten
Tue, 20 April 2027, 09:00–16:15 h
Wed, 21 April 2027, 08:30–16:30 h
All times mentioned are CEST.
Wed, 21 April 2027, 08:30–16:30 h
All times mentioned are CEST.
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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