Petra Barth, QS-Training.de, Germany
Dr Panagiotis Fakitsas, F. Hoffmann-La Roche, Switzerland
Dr Rainer Gnibl, GMP Inspector for EMA, Germany
Dr Alexander Pontius, Bayer, Germany
Audrey Schwebel, Procter & Gamble, France
Dr Georg Sindelar, msg industry advisors, Germany
Hans Steier, Vetter Pharma-Fertigung, Germany
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 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.
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.
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
- How the industry in the U.S. is dealing with this approach
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?
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: Managing Quality Oversight in the Company
- How to evaluate performance of different sites of the company and outsourced activities
- Maintenance, monitoring and feedback
(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
- 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
(2) Case Study Vetter Pharma-Fertigung: Quality Oversight in a CMO Business
- 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) 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) Case Study Procter & Gamble: Quality Risk Management in a complex global pharmaceutical Organisation 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
(5) Quality Oversight for a 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