Quality Oversight - Live Online Training Supervision of the Pharmaceutical Quality System: Challenges and Opportunities

16/17 May 2023

Course No 20162

This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager". Learn more.

All times mentioned are CEST.

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Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

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 Frank Seibel, Roche Diagnostics, Germany
Dr Georg Sindelar, msg industry advisors, Germany
Hans Steier, Vetter Pharma-Fertigung, Germany

Objectives

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.

Background

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.

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.

Technical Requirements

We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online- training-technical-information you will find all the information you need to participate in our events 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.

Programme

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.

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

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