iSpeak Blog
On the closing morning of the 2025 ISPE Europe Annual Conference, Jackson presented MHRA’s Policy for the Future and Globalized Industry.
Wendy McGhee
ISPE
Health Authority Outreach Manager- Regulatory Affairs
My name is Wendy McGhee, I am the Health Authority Outreach Manager on the Regulatory Affairs team for ISPE. I have worked in Quality and Regulatory compliance for many years. Prior work includes Quality Engineering, Legal contract writing, Quality Manager and Auditor for 1SO9001, 14001, 13485, 21 CFR 820, 21 CFR 210-211, CAPA, Recall notices, Root Cause, FMEAs, Software and Equipment Validation.
Related Articles
iSpeak Blog
The presentation by Ian Deveau, PhD, from the US Food and Drug Administration (US FDA) Office of Compounding Quality and Compliance at the 2024 ISPE Annual Meeting & Expo on 15 October 2024 provided an in-depth look at the US FDA’s perspective on drug compounding, its regulatory framework, and the significant events that have shaped current practices. Here is a summary of the key points...
iSpeak Blog
This blog summarizes a presentation by Rick Friedman, Deputy Director of the US FDA Office of Manufacturing Quality, on 17 April 2024 at the 2024 ISPE Europe Annual Conference in Lisbon, Portugal. The...
iSpeak Blog
Carla J. Lundi, US Food and Drug Administration (FDA) Senior Consumer Safety Officer, Division of Quality Intelligence II, FDA, presented the regulatory keynote at the 2024 ISPE Facilities of the Future...
iSpeak Blog
On Wednesday, 18 October 2023, Dr. Celia Lourenco, Associate Assistant Deputy Minister of Health Canada's Health Products and Food branch, presented a keynote address titled “Advanced Manufacturing and Other Trends Supporting Access to Medicines for Patients” at the
iSpeak Blog
What is Commenting?
As regulatory agencies invite public comment on a new or revised regulation or guidance, they look to ISPE for input on the latest scientific and technical developments. ISPE submits official comments when we are able to provide that input.
ISPE’s commenting process is overseen by ISPE’s Regulatory Quality Harmonization Committee (RQHC)...