On this episode, Stacey Bruzzese is joined by Karen Ginsbury, President & CEO of PCI Pharmaceutical Consulting Israel. Stacey and Karen talk about what’s new with global systems and regulatory guidelines.

 What’s new in Quality Management System

• For Virtual companies, what are their responsibilities in terms of quality systems?

More information on the topics discussed can be found at:

ISO 18091:2019

Quality management systems — Guidelines for the application of ISO 9001 in local government

     https://www.iso.org/standard/72808.html

Validation Week 2020

       http://www.cbinet.com/conference/pi20083

FDA Information on PQS

      https://www.fda.gov/media/92818/download

ICH Q10 Quality Management

      https://www.fda.gov/media/71553/download

IT and Computerized Systems Conference

     http://www.cbinet.com/conference/pi20045

ICH guideline Q10 on pharmaceutical quality system

 http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002871.pdf

ICH guideline Q9 on quality risk management

     http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002873.pdf

Karen has over twenty years of experience in the pharmaceutical industry. ... After leaving Teva, Karen set up her own consultancy company, PCI Pharmaceutical Consulting Israel Ltd which has been providing services to the pharmaceutical industry worldwide for the past 14 years.Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.