Dr Ulrich Rose
Straßburg
Referierende
Marieke van Dalen
MARA Consultancy
Zielgruppe
This ECA course is designed for all persons involved in the manufacture of APIs, especially for persons from production, quality
control, quality assurance, technical and regulatory affairs departments. We are also addressing interested parties from the pharmaceutical industry as well as GMP inspectorates.
control, quality assurance, technical and regulatory affairs departments. We are also addressing interested parties from the pharmaceutical industry as well as GMP inspectorates.
Zielsetzung
This ECA course provides an overview of the EU Pharmaceutical Legislation Reform and its impact on the API industry – from a regulatory and GMP point of view. During interactive sessions you will get to know:
- Which GMP and regulatory aspects have to be considered to successfully submit a change
- How to introduce a new intermediate manufacturer
- How to deal with a new impurity in your API and what actions have to be taken
- How to define critical quality attributes, critical process parameters, critical material attributes and an accurate control strategy
Furthermore, you will have the opportunity to reach clarification on ambiguous issues by bringing your questions up for discussion during the so-called break-out sessions.
This ECA course ideally complements the following 28th APIC/CEFIC Global GMP & Regulatory API Conference.
Programm
An Overview of the EU Pharmaceutical Legislation Reform
- Background of the revision
- Key elements of the proposal
- Important Changes for the API industry
- the revision of the variations guideline
- the introduction of the API certificate
Handling Revisions of CEPs at EDQM
- Impact of the EU guideline on classification of variations on the EDQM guideline for revisions of CEPs
- Key aspects to submit successfully a change
API Changes: Validation and Implementation
- Defining critical quality attributes, critical process parameters, critical material attributes and accurate control strategy
- Eudralex Vol 4 Annex 15 on process validation
- Implementation steps and performance monitoring
- Use PV and scientific knowledge to implement Lean GMP Systems
Case Studies
Introduction of a new Intermediate Manufacturer
- What to do in house: how to validate this change?
- What regulatory actions to take?
Finding a new Impurity in your API
- What to do in house: how to qualify this impurity?
- What regulatory actions to take?
Weitere Informationen
Date ECA course
Tuesday, 21 October 2025, 09.30 - 17.15 h
(Registration and coffee 09.00 - 09.30 h)
All times mentioned are CEST.
Venue
Barceló Sants Hotel
Plaça dels Països Catalans, s/n
08014 Barcelona
Spain
Phone: +34 (93) 503 53 00
sants@barcelo.com
Datum & Uhrzeiten
The API world is changing rapidly. Nowadays, changes are a daily business in the API industry. Companies are struggling with the challenge of how to implement the new regulations and requirements caused by e.g. reforms of the guidelines. To ensure the quality of their products throughout their life cycles, API changes need to be validated, submitted and implemented successfully. On the one hand, the theoretical obligations need to be considered and well known, while on the other hand the practical implementation needs to be beneficial and manageable in day-to-day API work.
Hot topics are presented in three lectures and two case studies. Additionally, you will have the chance to discuss your own topics with the speakers during the break-out sessions. Besides explaining the requirements of the guidelines of e.g. the revised variations guideline, for the respective themes, the speakers will share their approaches, experiences and best practices on these API related quality and regulatory Topics.
Teilnahmegebühr
| Regular Fee*: | € 1290,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
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E-Mail: info@concept-heidelberg.de
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