Course No 15179
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Dr Rainer Gnibl, GMP Inspector for EMA
Dr Panagiotis Fakitsas, F. Hoffmann-La Roche
Dr Rodrigo Pereira, Bial - Portela & Cª
Dr Jürgen Schmickler, ex.bros swiss
Dr Georg Sindelar, Chemgineering Business Design
Hans Steier, Vetter Pharma-Fertigung
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 support you turning your company’s
quality excellence goals into reality.
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 the new 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 cGMP 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 conference 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.
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.
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
Quality Oversight in the View of an EMA Inspector
The Basis: Pharmaceutical Quality Systems (PQS)
Essential elements of PQS to achieve EU GMP compliance
Management of PQS and their benefit from an inspectors point of view
Inspectors‘ expectations on Quality Oversight
Tools for Quality Oversight – is Quality Oversight really new?
Side glance to US-FDAs view on Quality Oversight – what are the differences?
Quality Oversight – Motor in a multinational Company
Implementation of a successful Quality Oversight strategy and program
Definition of critical processes and integration of a management control
and reporting system
Management of significant cGMP internal compliance problems and of a
Maintenance and monitoring
Information and communication
The link to continuous improvement
Quality Oversight – the effective Arm in your Transfer and CMO Business
Outsourcing and transfer strategies and business
Requirements, barriers and risks
Best practise - designing and integrating Quality Oversight in transfer and
Risk management and quality system oversight in the third party manufacturing network
Managing Quality in different Quality Cultures
Differences in culture and quality culture: what are the challenges?
Quality Operations in different continents: considerations, examples and best practices
(1) 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
The Warning Letter
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
(2) Case Study Vetter Pharma-Fertigung
Establishing a Quality Oversight system at an contract manufacturer
Interfaces to other systems
How it was seen by FDA
Person in the Plant Concept: advantages and challenges
(3) Roche Case Study: 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 while integrated in a technical product management set up.