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.

iSpeak Blog

Health Canada on Advanced Manufacturing and Other Trends

22 November 2023

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

ISPE’s Regulatory Commenting Process

14 February 2023

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)...

Wendy McGhee

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