Breil Yao，Pharmaceutical Industry Expert

Topic: 2^nd Edition ISPE Commissioning and Qualification (C&Q) Change Introduction

Speaker Bio

Breil Yao was the Group SC Director of Xiangxue pharmaceutical Co., Ltd. from Jul 2002 to Mar 2010, he took several positions from Engineer to Senior Supervisor in engineering in Hangzhou MSD pharmaceutical Co. Ltd.; From Mar 2010 to Aug 2018, he took the position as Maintenance Manager/Senior Maintenance Manager, Associate Engineering & EHS Director, and was certified as Six Sigma Black Belt in Lilly Suzhou pharmaceutical Co. Ltd.; And from Sep 2018 to Feb 2019, he took the position as a senior advisor in Suzhou Costar Pharmaeng Co., Ltd.

He graduated from Zhejiang University with bachelor degree of Mechanical Engineering in July 2002; and earned MBA of Zhejiang University from Sep 2005 to Mar 2011; He was certified as Black Belt of ASQ (American Society of Quality) in march, 2016; and was certified in Production & Inventory Management(CPIM) of APICS (American Production and Inventory Control Society) in Sep 2018.

 Presentation Summary

There are many changes in 2^nd edition of ISPE C&Q, most of them are positive but not all. This training will specify all changes, also introduce how to build C&Q system in pharmaceutical site.

There are mainly 6 change in 2^nd edition, including system category, risk evaluation, periodical review and template etc. This training will introduce all these change details. Also, there will be some opinion and thinking based on personal experience for reference.

For C&Q system building, it will be introduced with validation master planning, documentation structure, team and R&R, which will help you to build appropriate system in your site based on actual situation.