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
Case Studies
(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 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) 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
(5) Quality Oversight in Times of digital Transformation
- Dashboarding and Real Time Trending
- Prospective Quality Oversight
- Links to Knowledge Management and Artificial Intelligence (AI)