Dr Simone Biel
Merck
Referierende
Dr Desmond G. Hunt
United States Pharmacopeia (USP)
Will Parker
West Pharmaceutical Services
Highlights
- Understanding USP <665> and <383>
- From E&L Risk Assessment to Testing Decisions
- Designing extractables studies following the risk-based approach
- Understanding USP <665> and <383>
- From E&L Risk Assessment to Testing Decisions
- Designing extractables studies following the risk-based approach
Zielgruppe
The course is designed for personnel of pharmaceutical companies and their suppliers who
- are responsible for setting up E&L studies and E&L testing
- work in quality control of packaging materials
- specify and select polymeric and elastomeric materials, devices and Single Use (SUS) equipment in process development and manufacturing
- develop material sourcing strategies
Zielsetzung
In this Live Online Training you will learn
- How to evaluate potential risk factors associated with Extractables & Leachables (E&Ls)
- How to design extractables studies following the risk-based approach in USP <665>/<1665> and ICH Q3E
- How to control and manage the life cycle of E&Ls
The specific kind of extractable/leachable can vary from organic oligomers and catalyst residues to heavy metals – to name a few. Due to the resulting complexity, it is very important to consider the potential risk factors associated with leaching substances already at a very early stage in process development. Therefore, the ICH is currently working on a new ICH Q3E Guideline for Extractables and Leachables (E&Ls) to “assist both applicants and regulators by providing focus on critical aspects, and improving transparency in requirements for medicinal products including drug delivery device components”.
Programm
Understanding USP <665> and <383>: Standards for Plastic and Elastomeric Manufacturing Components
- Overview of USP <665> and USP <383>
- Implementation and alignment with existing practices
- Awareness, challenges, and areas where further clarification is needed
From E&L Risk Assessment to Testing Decisions: Does ICH Q3E Address All Uncertainties?
- Risk assessment approach to evaluate the level of test requirements of potential leachables
- SUS supplier approach to support with USP <665> standard extractables protocol
- ICH Q3E, is it conflicting with USP <665> or complementing?
- Some insights into the ICH Q3E comments provided via EMA and FDA: uncertainties, open questions
Designing extractables studies following the risk-based approach in USP <665>/<1665> and ICH Q3E
- How risk assessment and scoring determine what needs to be tested
- What are the differences between USP<665> and ICH Q3E that are relevant at this point?
- Selecting relevant extraction media, extraction conditions, and instrumentation
- How does this data fit into the eventual leachables testing that needs to be done on the finished product?
Weitere Informationen
Technical Information
We use Webex for our live online training courses and webinars. At 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)
Non-ECA Members EUR 890.-
ECA Members EUR 790.-
APIC Members EUR 840.-
(does not include ECA Membership)
EU GMP Inspectorates EUR 445.-
The conference fee is payable in advance after receipt of invoice.
ECA Members EUR 790.-
APIC Members EUR 840.-
(does not include ECA Membership)
EU GMP Inspectorates EUR 445.-
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.
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:
Dr Andrea Kühn-Hebecker, +49 6221 84 44-35, kuehn@concept-heidelberg.de
Questions regarding Organisation:
Ms Sonja Nemec, +49 6221 84 44-24, nemec@concept-heidelberg.de
Datum & Uhrzeiten
Wed, 20 Jan 2027, 12:45-17:00 h
All times mentioned are CET.
All times mentioned are CET.
Teilnahmegebühr
| ECA-Member*: | € 790,- |
| Regular Fee*: | € 890,- |
| EU/GMP Inspectorates*: | € 445,- |
| APIC Member Discount*: | € 840,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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E-Mail: info@concept-heidelberg.de
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