『13: What's hot in QRM?』のカバーアート

13: What's hot in QRM?

13: What's hot in QRM?

無料で聴く

ポッドキャストの詳細を見る

このコンテンツについて

 This episode was originally aired October 19th, 2021

This week, Stacey is joined by Nuala Calnan and Valerie Mulholland for an Ask Me Anything session on Quality Risk Management. 

Resources from this episode:
Risk-Based Decision Making: PODCAST RECORDING
https://www.ivtnetwork.com/article/risk-based-decision-making-podcast-recording
Risk Management, Knowledge Management and the Risk
https://www.ivtnetwork.com/article/risk-management-knowledge-management-and-risk-knowledge-infinity-cycle-risk-revolution
Understanding the Concept of Formality In Quality Risk ...
https://www.ivtnetwork.com/article/understanding-concept-formality-quality-risk-management
Quality Management Maturity – A Pilot Program of the FDA
https://www.ivtnetwork.com/article/quality-management-maturity-%E2%80%93-pilot-program-fda
ICH Q9 R1 concept document
https://database.ich.org/sites/default/files/Q9-R1_Concept%20Paper_2020_1113.pdf
ICH Q14 Concept Paper
https://database.ich.org/sites/default/files/Q2R2-Q14_EWG_Concept_Paper.pdf
2021 Updated PIC/s Aide Memoire on Assessment of QRM Implementation
https://picscheme.org/docview/3823
Sept 24 2021 Pre-post version of USP 1220 Chapter on Analytical Procedure Life Cycle
https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/usp-nf-notices/gc-1220-pre-post-20210924.pdf
QRM: a Case for Convergence:
https://arrow.tudublin.ie/cgi/viewcontent.cgi?article=1160&context=level3

About Our Guest:
Valerie Mulholland
Valerie Mulholland is the CEO of GMP Services Ltd and is a GMP/Quality Consultant in Europe. She is a practitioner in the area of Quality Risk Management and is researching the topic of Risk-Based Decision Making for a Ph.D. dissertation with the Pharmaceutical Regulatory Science Team in TU Dublin.

13: What's hot in QRM?に寄せられたリスナーの声

カスタマーレビュー：以下のタブを選択することで、他のサイトのレビューをご覧になれます。

Audible.co.jp

Amazon.co.jp
レビューはまだありません。