Dr Lance Smallshaw
UCB Biopharma SRL
Referierende
Test for Asbestos in USP Chapters <901> and <1901>
Zielgruppe
- Laboratory managers, supervisors, and analysts in pharmaceutical quality control (QC) departments
- Formulators and scientists in pharmaceutical development / product development
- Analytical chemists and other scientists
- Personnel from Quality Assurance (QA), Regulatory Affairs (RA), and contract laboratories / CROs
- Representatives from inspectorates and regulatory authorities
- Excipient and pharmaceutical manufacturers
- Academics and researchers
Zielsetzung
Talc is a naturally occurring hydrated magnesium silicate that plays an important role as an excipient in pharmaceutical formulations. Regulatory pressure on talc is driven by three primary factors: hazard classification, impurity control, and enforcement actions.
First, the European Chemicals Agency (ECHA) has recommended classifying talc as a Category 1B carcinogen, raising concerns about potential intrinsic health risks. Second, the United States Pharmacopeia (USP) has updated the talc monograph to strengthen asbestos detection and impurity control. These changes introduce stricter analytical expectations that pharmaceutical companies must implement to demonstrate the suitability of talc for use in drug products. Third, the U.S. Food and Drug Administration (FDA) has increased enforcement activity through Warning Letters and inspection findings, highlighting shortcomings in current industry practices related to talc testing and verification.
Together, these elements create a regulatory landscape that requires pharmaceutical manufacturers to maintain robust quality systems. Companies must not only meet specific analytical requirements, but also demonstrate a risk-based, end-to-end understanding of talc-related hazards within their quality system.
Programm
The following topics will be covered:
- Introduction to talc in pharmaceuticals
- ECHA classification and scientific basis
- USP monograph and analytical requirements
- FDA enforcement and compliance implications
A Q&A session will follow the presentation, giving participants the opportunity to ask questions.
Weitere Informationen
Technical Requirements
Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
Presentations/Certificate
The presentations for this event will be available for you to download and print before and after the event. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
The presentations for this event will be available for you to download and print before and after the event. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
Fees (per delegate, plus VAT)
Non-ECA Members EUR 399
ECA Members EUR 349
The conference fee is payable in advance after receipt of invoice. VAT is reclaimable.
Group Participation (fee per delegate, plus VAT):
3-10 Persons EUR 359,10
11-20 Persons EUR 319,20
more than 21 Persons EUR 279,30
Contacts
Questions regarding content:
Dr Markus Funk +49 6221 84 44-40, funk@concept-heidelberg.de
Questions regarding organisation:
Ms Marion Grimm +49 6221 84 44-18, marion.grimm@concept-heidelberg.de
Datum & Uhrzeiten
Mon, 21 Sep 2026, 14:00–16:00 h
All times mentioned are CEST.
Teilnahmegebühr
| ECA-Member*: | € 349,- |
| Non ECA Member*: | € 399,- |
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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