The intricacies of Computer System Validation in the Pharmaceutical industry
Voices In Validation
English - December 31, 2019 05:00 - 31 minutes - 28.6 MB - ★★★★★ - 8 ratingsChemistry Science Homepage Download Apple Podcasts Google Podcasts Overcast Castro Pocket Casts RSS feed
On today’s episode, Stacey Bruzzese welcomes Chris Wubbolt to talk about validation of manufacturing equipment, processes and computer systems – both hardware and software.
Stacey and Chris talk about a variety of topics:
Chris gives a brief overview of CSV and why it’s important to the integrity of the product
Chris explains why, in an FDA regulated laboratory, CSV is not only concerned with computer hardware and software
What is the impact on the Pharma industry of going paperless and relying more on computer documentation?
What are some of the biggest hurdles for compliance?
What are some of the best practices for big data and data integrity?
How will implementing more technologies like IoT and AI impact CSV?
Where does Chris see things heading in the future?
Chris has over 25 years’ experience in regulated industry and has provided compliance, quality assurance and computer validation consulting services. He remains current in industry trends and requirements and frequently speaks or provides workshops at leading industry conferences and programs. Chris has a master’s Degree in Quality Assurance and Regulatory Affairs and a BS in Physics and Computer Engineering, along with a Six Sigma Black Belt Certification.
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.