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Home > Voices In Validation > What’s Trending and Timely in Life Sciences?


	Podcast:		Voices In Validation
	Episode:		What’s Trending and Timely in Life Sciences?
	Category:		Science & Medicine
	Duration:		00:39:37
	Publish Date:		2020-02-18 05:00:00
	Description:		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? What’s the new EU guidance around vendors and responsibility? What will the impact be of new Draft PIC/S recommendations on how to demonstrate the effectiveness of a Pharmaceutical Quality System? What are the differences in protocols for QRM systems in digitally enabled and fully automated labs? What’s happening with Annex 1? 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.
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