Target Group
Objectives
- What has to be considered when starting materials have to be defined
- How risk assessment can be applied
- Which aspects have to be taken into account when applying for a CEP
- How quality agreements should look like
- How post approval changes can be handled and
- How impurities in starting materials can be controlled
Furthermore, you will have the opportunity to join two case studies about
- How to define suitable starting materials in API syntheses
- How to defend the choice of the starting material in the submission
Programme
- API Regulatory Starting Materials – overview of guidelines
- Definition according to the guidelines
- Global guidelines (ICH Q7 and Q11)
- US, EU and Japan guidance
- How to use the term “significant structural fragment”
- Distinguishing starting materials from raw materials, reagents and solvent
- Selection of an appropriate starting material
- Starting material specification
- Differences between the expectations of health authorities
- Consequences in case of changes
- Practical experiences
- Regulatory background
- Scope of the CEP procedure
- Provisions of the Guideline PA/PH/CEP (14) 06 “Use of a CEP to describe a starting material in an application for another CEP“
- Important points to be considered for defining an API starting material
- What kind of changes could occur?
- How to classify these changes?
- What information to submit?
- Criticality analysis methods (HAZOP, FMEA etc)
- Critical quality attributes (CQA) and critical process steps (CPS)
- Linking CQA and synthesis steps
- Critical impurities
- Critical raw materials
- Process criticality analysis; example
- API synthesis: How to define suitable starting materials
- How to defend the choice of the starting material in the submission
- How to control impurities in a starting material
- Analytical techniques
- Optimisation of chromatographic methods
- Downstream experiments
- Validation of analytical procedures
- Qualification of starting materials
- Impact of ICH Q7 Q&A and ICH Q11 on auditing starting material manufacturers
- Health authority and regulatory expectations
- Risk-based approach on “How to “ audit starting materials
- Development and use of the APIC guideline on auditing starting materials
- Practical examples and case studies
Further Information
Technical Requirements
We use Webex for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Fees (per delegate plus VAT)
ECA Members € 1,890
APIC Members € 1,990
Non-ECA Members € 2,090
EU GMP Inspectorates € 1,045
The conference fee is payable in advance after receipt of invoice.
Presentations/Certificate
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
Contacts:
Questions regarding content:
Ms Anne Günster (Operations Director) +49(0)62 21/84 44 50, guenster@concept-heidelberg.de
Questions regarding organisation:
Mr Niklaus Thiel (Organisation Manager) +49(0)62 21/84 44 43, thiel@concept-heidelberg.de.
Date & Time
Thu, 26 February 2026, 09:30 - 16:30 h
Costs
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
(All prices excl. VAT). Important notes on sales tax.
not available
not available
This course is part of the GMP Certification Programme "ECA Certified Regulatory Affairs Manager"
Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
Testimonials
