Kerstin Hurst, F. Hoffmann-La Roche,Switzerland
Heide Nagel, Novartis Pharma, Switzerland
Dr Bettina Rietz-Wolf, GMP Inspector, Local Authority of Baden Württemberg, Germany
Hans Steier, Vetter Pharma-Fertigung, Germany
Dr Florian Witte, Boehringer Ingelheim Pharma, Germany
- Learn about the US FDA‘s expectation of a Quality Oversight programme
- Is Quality Oversight just an FDA expectation? What are the expectations of European Inspectors?
- Quality Oversight; only a regulatory expectation? What advantages can you gain from the implementation for your own company?
- How are Quality Oversight requirements implemented in sterile production? In 4 case studies, you will be presented with concepts and implementation Options
In the „Guidance for Industry - Sterile Drug Products Produced by Aseptic Processing“ published in 2004, the FDA clearly formulated the expectations for Quality oversight. The aim should be to ensure regular and independent checks of the processes and personnel involved in aseptic manufacturing and thus reduce the risk of product contamination. In several warning letters in recent years, companies have been criticised for insufficient „quality oversight“.
In addition, against the background of new or revised European regulations, e.g. Annex 1 or Annex 15,
EU GMP Guide Annex 15 „1.3 ...However, there should be appropriate quality oversight over the whole validation life cycle“.
every European company faces the question of how the American demands for Quality Oversight will also be taken up in the regulatory environment here in the future.
The Live Online Training is aimed at responsible employees in sterile production who are involved in the planning, establishment and implementation of a Quality Oversight programme in their companies. The following areas are specifically addressed
- Quality Assurance
For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At https://www.webex.com/test-meeting.html
you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Quality Oversight and GMP in the EU
- Overview of regulatory requirements in the EU
- The PQS (Pharmaceutical Quality System) as a Basis
- Requirements acc. to Annex 1 (Draft)
Expectations of an Inspector
FDA Guidance for Industry „Sterile Drug Products Produced by Aseptic Processing” (2004)
„Similarly, the quality control unit should provide regular oversight of adherence to established, written procedures and aseptic technique during manufacturing operations“.
Quality Oversight in Aseptic Manufacturing: FDA Expectation and Requirements
- FDA regulatory requirements
- Expectations regarding Quality Oversight: Requirements and Principles
- Background for FDA Quality Oversight Requirements
Implementation of Quality Oversight: Case Study Boehringer Ingelheim. Opportunity forContinuous Improvement or Formal Compulsion?
- Learn how to implement Quality Oversight efficiently by means of concrete examples
Case Study Vetter Pharma-Fertigung: Quality Oversight in Sterile Manufacturing
- Establishing a Quality Oversight system at an CDMO in sterile manufacturing
- FDA expectations and audit experiences
- Interfaces to other Quality system
- PIP - Person in the Plant Concept
- Advantages and challenges
- Regulatory outlook, Annex1 - Quality Oversight elements
Case Study Roche
- Quality Oversight – Definition
- Quality Oversight Strategy at Roche Kaiseraugst
- Implementation of Quality Oversight at Roche Kaiseraugst
- Prerequisites, opportunities and risk of Quality Oversight
Aseptic Operator Certification Programme in Sterile Production within the Scope of QA-Oversight
- Training programme
- Certification and Re-certification procedure
- Training videos
Case Study Novartis: QA-Oversight in Sterile
- QA Oversight concept
- Training of QA-Oversight personnel (Train-the-Trainer)
- Procedure in case of QA-Oversight observations