This 2-day Live 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.
Background
The U.S. 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 Gui-dance 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.
Target Group
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.
Date & Technical Requirements
Date Tuesday, 27 May 2025, 9.00h – 16.15h Wednesday, 28 May 2025, 8.30h – 16.30h All times mentioned are CEST.
Technical Requirements We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
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
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 (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
Quality Oversight in Times of digital Transformation
Dashboarding and Real Time Trending
Prospective Quality Oversight
Links to Knowledge Management and Artificial Intelligence (AI)
This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager" Learn more
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Testimonials
Seminar Programme as PDF