Dr Cornelia Nopitsch-Mai
formerly Quality Assessor
Referent:innen
Dr Thomas Uhlich
Bayer
Dr Josef Hofer
exdra
Dr. Thomas Fürst
Boehringer Ingelheim
Dr Heiko Brunner
Hamburg
Dr Ulli Backofen
Boehringer Ingelheim
Please also see the course “Setting Specifications and Acceptance Criteria” on 03/04 November 2026, which will take place directly before this course. Click here to book both training Courses and save € 400.
Zielgruppe
- Personnel and specialists from QA, QC and Regulatory Affairs departments in the API and pharmaceutical industry
- Personnel from contract development and manufacturing organisations
- Representatives of EU inspectorates and regulatory authorities
Zielsetzung
Analytical methods that were not “stability-indicating” are frequently cited in FDA 483s and Warning Letters. This course will thus address how to set impurity limits for related substances and degradation products based on method capability and stability results.
This course is intended to provide information on different aspects of stability testing. The course will be opened by an overview of stability testing with a special focus on the ICH Guidelines. In the subsequent presentation, important aspects of stability testing for biologicals and throughout drug development are discussed. Another lecture focuses on stability testing for Drug Substances, followed by a talk on Drug Products. In a further presentation, the focus lies on the various aspects of submitting stability data. Finally, statistical considerations will be covered in another lecture.
Programm
Current ICH and CHMP Guidelines for Stability Testing
- Overview of Stability Guidelines
- Concepts of Stability testing
- Retest period and Shelf-life
- Post-marketing Stability Studies
- Future Activities
Stability Testing for Biologicals
- Overview of regulatory requirements
- Types of stability studies for Biopharmaceuticals
- Practical aspects of stability studies with Biopharmaceuticals
- Degradation pathways
- Setting shelf life during early and late stage development
Stability Testing throughout Drug Development
- Must the development stability programme meet ICH Q1A?
- Stability testing from early development to product launch
- Clinical stability for comparators
- Site specific stability
Stability Testing for Drug Substances
- Stability protocols
- Stress testing
- Photostability testing
- Documentation
Stability Testing for Drug Products
- Strategy of Stability Testing
- Performance of new Drug Products
- Related Finished Products with existing substances
- Follow-up Stability Testing
Submitting Stability Data
- Regulatory Strategy Stability
- Drug Substance and Drug Product Stability Data and Evaluation
- Storage recommendations/labelling/SmPC
- Stability studies, commitments post approval
- Typical questions from authorities and answers
Evaluation of Stability Results – Statistical Considerations
- Sample number and replication
- Trend analysis
- Outliers
- Pooling of batch data
- Shelf life prediction
Weitere Informationen
Venue
Barceló Sants Hotel
Plaça dels Països Catalans, s/n
08014 Barcelona
Spain
+34 (93) 503 53 00
sants@barcelo.com
Barceló Sants Hotel
Plaça dels Països Catalans, s/n
08014 Barcelona
Spain
+34 (93) 503 53 00
sants@barcelo.com
Accommodation
CONCEPT HEIDELBERG has reserved a limited number of rooms. You will receive a room reservation form/POG when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.
CONCEPT HEIDELBERG has reserved a limited number of rooms. You will receive a room reservation form/POG when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.
Fees (per delegate, plus VAT)
Non-ECA Members € 1,290
ECA Members € 1,090
APIC Members € 1,190
EU GMP Inspectorates € 645
The conference fee is payable in advance after receipt of invoice and includes dinner on the first day, lunch on the second day and all refreshments. VAT is reclaimable.
Non-ECA Members € 1,290
ECA Members € 1,090
APIC Members € 1,190
EU GMP Inspectorates € 645
The conference fee is payable in advance after receipt of invoice and includes dinner on the first day, lunch on the second day and all refreshments. VAT is reclaimable.
Presentations/Certificate
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
The official conference language will be English.
Contacts
Questions regarding content:
Dr Markus Funk, +49 (0)6221 84 44 40, funk@concept-heidelberg.de
Questions regarding organisation:
Ms Marion Grimm, +49 (0)6221 84 44 18, grimm@concept-heidelberg.de
Questions regarding content:
Dr Markus Funk, +49 (0)6221 84 44 40, funk@concept-heidelberg.de
Questions regarding organisation:
Ms Marion Grimm, +49 (0)6221 84 44 18, grimm@concept-heidelberg.de
Datum & Uhrzeiten
Wed, 04 Nov 2026, 14:00-18:00 h
(Registration and snack 13:30-14:00 h)
Thu, 05 Nov 2026, 08:30-15:00 h
(Registration and snack 13:30-14:00 h)
Thu, 05 Nov 2026, 08:30-15:00 h
Teilnahmegebühr
| ECA-Member*: | € 1090,- |
| Non ECA Member*: | € 1290,- |
| EU/GMP Inspectorates*: | € 645,- |
| APIC Member Discount*: | € 1190,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
Für Lieferanten: Ausstellungs- und Sponsoringmöglichkeiten
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