Dr Joachim Ermer
Ermer Quality Consulting
Referierende
Dr Ulrich Kissel
European QP Association (EQPA), KisselPharmaConsulting
Dr. Ralf Schreiner
QProgress
Dr Sue Mann
Sue Mann Consultancy
Ian Pardo
Spires Quality / RareGenix
With a View on the Detailed Commission guideline on GMP for IMPs
- Legal Requirements and Authority Inspections
- GMP Issues and best Practices
- Case Studies and practical Examples
Zielgruppe
This course has been designed for R&D personnel involved in Pharmaceutical Development, IMP Manufacturing, Quality Control, Quality Assurance and Regulatory Affairs.
Zielsetzung
Complex challenges have to be faced and resolved to guarantee high quality products. The safety of the drug and hence also the patient should always be the main focus. Terminated studies or studies without reliable results will lead to extensive extra costs and delays in the whole development and approval process.
This course has been designed by the ECA to broaden your knowledge and to consolidate the various GMP aspects which need to be considered in a successful development of a new pharmaceutical product.
During this course, specialists will share their expert knowledge about all important GMP aspects in Pharmaceutical Development and Investigational Medicinal Product (IMP) Manufacturing. You will be able to elaborate and discuss both EU and FDA requirements.
Programm
Global GMP Requirements from Phase 1 to Scale-up and Transfer
- Global requirements: applicable law, directives, guides and guidelines: what is really required
- A comparison of FDA and European requirements and expectations
IMPs in the Context of ICH Q8-Q10, Q12 and Q14
- How to integrate Quality by Design (QbD)
- Risk Analysis in Pharmaceutical development
- Life cycle concept
Important Documents in Pharmaceutical Development
- Early documentation
- CTD
- PSF: style and Content
- Case studies
Analytical Development (ICH Q14)
- From method development to method validation
- Quality control and IMP release
- Analytical Qualification
Packaging and Supply of Clinical Trial Materials
- GMP requirements
- Quality control of packaging and labelling
- Handling and sourcing of comparators
- Randomisation and blinding
How to handle Deviations in an R&D Environment
- Why we need a process for Deviations
- What we need to know
- How to do it
Change Control for IMPs
- What is required
- What is important
- What are the benefits
- How to implement
IMP Manufacturing: How much Qualification and Validation is needed?
- Qualification vs. Validation
- What can be found in the regulations
- DQ/IQ/OQ of equipment
- How much process validation is needed?
Cleaning Validation / Verification in Pharmaceutical Development
- Cleaning validation vs. cleaning verification
The FDA Pre-Approval Inspection (PAI)
- Involvement of the R&D Department
- What the FDA will look for
- What happens at FDA during and after the PAI
- Responding to FDA after the PAI
The Role of the QP in Pharmaceutical Development and IMP Release
Interactive Sessions
1. Transition of GMP Requirements from Phase 1 to Phase 3 and the Interface to Development Work
- Responsibilities
- Co-operation with Head of Production and Head of Quality Control
- Confirmation of Compliance, certification and batch release
- Comparators
- Complaints and recalls
The GMP/GDP/GCP Interface
- Reconstitution
- Pre-requisites for randomisation and blinding
- Distribution
- Site-to-site Transfers
- Shelf life extension
- The QP: where does the responsibility end?
Interactive Sessions
1. Transition of GMP Requirements from Phase 1 to Phase 3 and the Interface to Development Work
- Challenges and Differences
- How to apply phase appropriate GMPs
- Managing a GMP Lifecycle
2. Stability Studies throughout the Development of a new Product
- Different types of products in CT studies (and support)
- APIs and various dosage forms
- Late stage stability strategies
- New draft ICH Q1 Guideline
3. Data Integrity
- Manufacturer‘s understanding of data integrity, needs and benefit
- Regulatory expectations
- Hybrid systems (paper and electronic records) - how to ensure data integrity?
You will be able to attend 2 of these parallel sessions. Please choose the ones you like to attend when you register for the course.
Weitere Informationen
Venue
Heidelberg Marriott Hotel
Vangerowstr. 16
69115 Heidelberg
+49 6221 90-80
info.heidelberg@marriott.com
Heidelberg Marriott Hotel
Vangerowstr. 16
69115 Heidelberg
+49 6221 90-80
info.heidelberg@marriott.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 EUR 2,490
ECA Members EUR 2,290
APIC Members EUR 2,390
EU GMP Inspectorates EUR 1,245
The conference fee is payable in advance after receipt of invoice and includes conference documentation, dinner on the first day, lunch on both days and all refreshments. VAT is reclaimable.
Non-ECA Members EUR 2,490
ECA Members EUR 2,290
APIC Members EUR 2,390
EU GMP Inspectorates EUR 1,245
The conference fee is payable in advance after receipt of invoice and includes conference documentation, dinner on the first day, lunch on both days and all refreshments. VAT is reclaimable.
Social Event
On 18 November 2026, you are cordially invited to a social event. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
On 18 November 2026, you are cordially invited to a social event. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
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 Andrea Kühn-Hebecker, +49 6221 84 44-40, kuehn@concept-heidelberg.de
Questions regarding organisation:
Sonja Nemec, +49 6221 84 44-24, nemec@concept-heidelberg.de
Datum & Uhrzeiten
Wed, 18 Nov 2026, 10:00-17:15 h
(Registration and coffee 09:30-10:00 h)
Thu, 19 Nov 2026, 09:00-17:00 h
Fri, 20 Nov 2026, 09:00-13:30 h
(Registration and coffee 09:30-10:00 h)
Thu, 19 Nov 2026, 09:00-17:00 h
Fri, 20 Nov 2026, 09:00-13:30 h
Teilnahmegebühr
| ECA-Member*: | € 2290,- |
| Non ECA Member*: | € 2490,- |
| EU/GMP Inspectorates*: | € 1245,- |
| APIC Member Discount*: | € 2390,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Pharmaceutical Development 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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