Dr. Rainer Gnibl
GMP Inspektor, Regierung von Oberbayern
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
Zielsetzung
This 2-day 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 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 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.
Technical Details
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Programm
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
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.
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
- 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 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
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
Case Study Vetter Pharma-Fertigung: Quality Oversight in a CMO Business
- 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 for an interface GMP/GDP-process: Offshoring of Complaint-Handling to Shared Service Centers
- Establishing a tailor-made, novel QMS incl. corresponding processes and procedures
- Qualification and training of personnel for the new units
- Implementing variants for multi-national and multi-language purposes
- Concept for process validation and hypercare Phase
- Making the new units ready for Quality audits
- Several aspects of Quality oversight beyond GxP
Case Study: Quality Risk Management as enabler for Knowledge Management and Quality Oversight
- How to implement QRM oversight: harmonisation as one of the key elements
- Management of risks
- Example of implementation of an IT tool enabling a better overview
- Delimitation of responsibilities and interfaces over the product life cycle
Recording from 16/17 May 2023
Duration of the recording: approx. 8 h 30 min.
Duration of the recording: approx. 8 h 30 min.
| ECA-Member*: | € 1590,- |
| Regular Fee*: | € 1790,- |
| EU/GMP Inspectorates*: | € 895,- |
| APIC Member Discount*: | € 1690,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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