Regulatory Roundup: Presentations Available from ICH Quality Workshops.

The presentations from the ICH quality-trio workshop series, held in Bethesda, Maryland, Oct. 6–8, are now available on the ISPE website. The workshop featured members of the ICH Quality Implementation Working Group, including representatives from FDA and EMA, and focused on design space, control strategy, quality systems, and risk management. Also on the website is a downloadable copy of the case study used in the workshop. The case study uses a fictional active pharmaceutical ingredient (API) to describe how to implement quality-based approaches to develop pharmaceutical manufacturing processes.