Webcasts

In this presentation, FDA has identify all the changes that have occurred in preparation for fulfilling our GDUFA II commitments for the IID and changes yet to come in 2020.

This webinar is a first-hand account of the challenges to realizing, determining, and confirming the novel status of an inactive ingredient in a Phase III Clinical drug product.

IPEC-Americas members have been busy while quarantined, and several new guides and position papers have been finalized.

This webinar focused on current and emerging CFDA regulatory activities in China related to the use and approval of excipients.

Nitrosamines and related compounds are a hot topic among regulatory agencies in the U.S., Europe, Canada, Brazil and elsewhere.

A comprehensive overview of Excipient World 2020… and walk away with a clear understanding of why you should attend!

The presenter discussed what a pharmaceutical company should do when their excipient supplier won’t allow an on-site audit.

Review of the regulations and guidelines which apply to pharmaceutical excipient use in primary Latin American countries (e.g. Brazil, Argentina, MERCOSUR, Andes, Mexico).

This webcast provides an overview of microplastics and highlights issues that both users and makers can consider when submitting individual company responses to ECHA.

Webinar recording from March 27, 2019. The new topic will address regulatory practices regarding inactive ingredients used in cosmetics, food, dietary supplements and pharmaceuticals.

Titanium dioxide (TiO₂) E171 has been proven to be safe for use in food and pharmaceutical applications by many studies over the years.

The webinar will provide an overview of excipient composition & complexity.

This webinar will review the issues surrounding technically unavoidable particles (TUP) and explain how the TUPPs guide can be used for evaluating visible particles in excipients.

Ralph Lindblad presents: Auditing to Monitor the Excipient Manufacturer; Partnering for success; building relationships with the supplier and excipient assessors. 

This webcast will discuss the importance of additives, impurities and concomitant components to excipient function.

This webcast is an overview of the IPEC guide Qualification of Excipients for use in Pharmaceuticals.

This webinar will provide excipient users with specific, practical advice on the implementation of elemental impurities requirements for finished dosage forms.

Confused by the various excipient GMP standards, schemes and guides? This webcast will set you straight about NSF/IPEC/ANSI 363 Excipient GMPs, EXCiPACT™, and the IPEC-PQG GMPs.

This is a practical introduction to the whys and how-tos of conducting risk assessments for excipients.

(FREE) Find out how the IPEC-Americas Excipient Learning Lab can significantly improve your excipient training and education return on investment (ROI).

Learn how IPEC is helping excipient makers, distributors, users and regulators develop a system of Total Excipient Control.

Every regulatory professional should know the standards, groundwork, expertise and technology required to submit compliant eCTD submissions to FDA.

What are Atypical Actives and How Should They be Regulated: GMP and Regulatory Filing Implications