Data Integrity: Hidden issues and Blind Spots
Voices In Validation
English - January 28, 2020 05:00 - 30 minutes - 27.6 MB - ★★★★★ - 8 ratingsChemistry Science Homepage Download Apple Podcasts Google Podcasts Overcast Castro Pocket Casts RSS feed
On today’s episode, Stacey Bruzzese welcomes Dr. Siegfried Schmitt, Vice President Regulatory and Access at PAREXEL. They discuss how to avoid blind spots when it comes to data integrity.
What systems and processes need to be included in my Data Integrity program?
Who is responsible for oversight?
Siegfried talks about a common misconception about electronic data
Are informal notes and brainstorming sessions part of the data integrity equation?
Why are so many of us not adhering to our own internal policies?
How can I increase awareness to potential data integrity issues?
Stacey and Siegfried discuss violations in conduct
What is managements role in these cases?
Siegfried shares some strategies for identifying hidden issues
Dr. Siegfried Schmitt is Vice President, Regulatory and Access, at PAREXEL Consulting, where he has worked at developing and improving quality management systems; including Quality by Design and Control Strategies since 2007. He is a Thought Leader in Competitive Compliance, Data Integrity and Supply Chain, as well as a trusted expert for regulatory, compliance and industry-best-practices projects. Siegfried has more than 30 years’ experience in the healthcare industry, spanning manufacture, analytics, validation and quality assurance. He received his Ph.D. in Organic Chemistry from the University of Berne, Switzerland and is a Fellow of the Royal Society of Chemistry.
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