Dr. Svenja Lacher, 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 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
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
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
Recording from 17 November 2022
Duration of the recording: approx. 5 h 5 min