- Datum:
-
- Webinar
Quality Oversight in Sterile Manufacturing (With 4 Case Studies) - Live Online Training
- Veranstaltungsort:
- online
- Veranstalter:
- CONCEPT HEIDELBERG GmbH
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
CONCEPT HEIDELBERG GmbH
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69123 Heidelberg
Deutschland
Telefon: +49 6221 844415
Telefax: +49 6221 844464
eMail: info@concept-heidelberg.de
Internet: http://www.gmp-navigator.com/
