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Wednesday, April 11 • 10:30am - 12:00pm
Session R - I.T. Compliance Track

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R-1  Server virtualization, cloud technology and impact to data integrity in regulated environments

Abstract: TBA

Category: TBA

Level of Content: TBA

R-2   Electronic Signatures and how to use them

Abstract:
This is a Case Study on how to obtain digital signatures to eliminate paper documentation.   To start with you must have a work process that is simple to use and eliminates redundancy.  Next, you need to understand the basics of obtaining a digital certificate and how it works.   Now that you have a digital certificate and before you can apply it to a document, that document must be properly prepared to accept the digital certificates.  One the key attributes is to allow multiple signatories the ability to sign a single document and a central site is needed for access, storage  or archive the documents.  Finally, you need to validate the process to Part 11.

Category:
IT Compliance

Level of Content:
Advanced 
Moderators
avatar for Mohammed Imran

Mohammed Imran

Senior Quality Assurance Auditor, Smithers Avanza Biopharmaceutical Services
Mr. Imran has 20+ years working in regulated study environment and a MLS (ASCP)-licensed professional, starting as a research associate to QA in 1999. Responsible for performing quality assurance functions for the Bioanalytical Services Unit for non-clinical and clinical GLP/regulated... Read More →

Speakers
avatar for Dr. Krishna Ghosh

Dr. Krishna Ghosh

FDA
Krishna Ghosh, Ph.D. is a Medicinal Chemist with over 20 years of industry experience in Product Development, Manufacturing /Operation/ Business Management, Quality Assurance, Quality Control and Regulatory Affairs in biotech and pharmaceutical companies. She has extensive experience... Read More →
avatar for Patricia Miller

Patricia Miller

Sr. Mgr, QA IT, Global Quality Systems, Seqirus, Inc.
Ms. Patricia Miller is a Senior Manager of QA IT in the Global Quality Systems Group at Seqirus, Inc. in Holly Springs, NC, where she oversees the compliance and data integrity of regulated computerized systems across the entire company, including the R&D and manufacturing systems... Read More →

Wednesday April 11, 2018 10:30am - 12:00pm PDT
Platinum 3&4
  Concurrent Session

Attendees (40)