Dr Lance Smallshaw
UCB Biopharma SRL
Referierende
Shortcuts: Compact learning units of 1–3 hours. Book online, receive access within minutes and benefit from 7 days of on-demand availability, giving you maximum flexibility in your day-to-day work.
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 are covered:
- Asbestos forms and health-risk context
- ECHA / EU regulatory and scientific Framing
- USP monograph, analytical methods and laboratory verification
- Stakeholder implementation reality
- Reference standards and laboratory governance
- Global pharmacopoeial context and comparison
- FDA enforcement and CGMP expectations
- Integrated action plan
Weitere Informationen
The purchase process for the GMP & GDP Shortcuts is handled via the sales platform Digistore24 (www.digistore24.com). Please understand that it is not possible to place an order on account in this case.
By clicking the “Book now” button at the top right, you will be redirected to Digistore24. After successful payment, you will automatically receive a confirmation email from Digistore24 and an email from Memberspot (our streaming provider) asking you to register.
Afterwards, you will have access to the purchased video for 7 days.
Please note: The booking is valid only for the registered participants. The use by other persons is prohibited and constitutes an infringement of copyright.
Presentation and certificate:
Starting from the purchase date, the presentation will be available for you to download in Memberspot for 7 days. Afterwards, the participants can download a certificate of attendance.
Contacts
Questions regarding content:
Dr Markus Funk, +49 6221 84 44-40, funk@concept-heidelberg.de
Questions regarding organisation:
Ms Sonja Nemec, +49 6221 84 44-24, nemec@concept-heidelberg.de
Duration of the Shortcut: 1h 25m
Recorded in September 2026
Please note:
When you click on "Register", you will be redirected to www.digistore24.com. Once your payment has been successfully completed, you will immediately receive 7 days’ access to the Shortcut you ordered via the Memberspot streaming platform. We kindly ask for your understanding that payment by invoice is not possible.
Teilnahmegebühr
| Regular Fee*: | € 399,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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