Quality Oversight in Sterile Manufacturing - Live Online Training
Wednesday, 3 December 2025 9 .00 - 17.15 h
Course No. 22080
Speakers
Hans Steier
Vetter Pharma-Fertigung
Dr Bettina Rietz-Wolf
Regierungspräsidium Tübingen
Michael Grosser
Lonza Biologics
Dr. Florian Witte
Boehringer Ingelheim
Svenja Lacher
F. Hoffmann-La Roche
Note: All times mentioned are CET.
Objectives
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
Background
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.
Target Group
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
Production
Quality Assurance
Microbiology
Technical Requirements
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.
The PQS (Pharmaceutical Quality System) as a Basis
Requirements acc. to Annex 1
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)
Testimonials
Seminar Programme as PDF