Quality Oversight in Sterile Manufacturing - Live Online Training
including 4 Case Studies
Wednesday, 3 December 2025 9 .00 - 17.15 h
Course No. 22080
Speakers
Hans Steier
Vetter Pharma-Fertigung
Dr. Florian Witte
Boehringer Ingelheim
Michael Grosser
Lonza Biologics
Svenja Lacher
F. Hoffmann-La Roche
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
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.
Programme
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
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
Further Information
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 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.
Fees (per delegate plus VAT) ECA Members € 1,090 APIC Members € 1,190 Non-ECA Members € 1,290 EU GMP Inspectorates € 645 The conference fee is payable in advance after receipt of invoice
Presentations/Certificate The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
Contacts: Questions regarding content: Mr Clemens Mundo (Operations Director) +49(0)62 21/84 44 42, mundo@concept-heidelberg.de Questions regarding organisation: Ms Sonja Nemec (Organisation Manager) +49(0)62 21/84 44 24, nemec@concept-heidelberg.de.
Date & Time
Wednesday, 3 Dec. 2025, 09.00 – 17.15 h CET
This training/webinar cannot be booked. Send us your inquiry by using the following contact form.
To find alternative dates for this training/webinar or similar events please see the complete list of all events.
For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.
Testimonials
