SQA Regulatory Surveillance Summary for January 2023 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner China: National Medical Products Administration (NMPA) NMPA Announcement on putting into use the electronic certificates… read more →
SQA Regulatory Surveillance Summary for September and October 2022 Agência Nacional de Vigilância Sanitária (ANVISA) ANVISA’s Questions & Answers (Q&A) on Medical Cannabis for Clinical Investigations, 14 September 2022 ANVISA… read more →
By Gilberto Jimenez, SQA Senior Engineering Director PFMEA is a methodology for analyzing any sort of process. Some reasons to utilize this tool include when a process is being designed… read more →
United States Food and Drug Administration (US FDA) Guidances Use of Electronic Health Record Data in Clinical Investigations: July 2018 US FDA has published a guidance for industry entitled Use… read more →
Imagine a customer approaching your store, a big smile on his or her face. The customer greets the doorman with a cheery “Hello!” and they exchange pleasantries. He or she… read more →
To remain competitive, continuous improvement is necessary in all areas of a company. Too often, focus is kept on product development and customer service, and Supplier Quality Management is neglected… read more →