Regulatory Landscape: ECHA, USP, Pharmacopoeias and FDA Enforcement
Monday, 21 September 2026 14.00 - 16.00 h
Course No. 23119
Speakers
Dr Lance Smallshaw
UCB Biopharma SRL
Test for Asbestos in USP Chapters <901> and <1901>
Target Group
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
Objectives
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.
Programme
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.
Further Information
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.
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.
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
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