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Tuesday, April 10 • 3:30pm - 5:00pm
Session H - I.T. Compliance Track

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H-1  The Role of Metadata and Audit Trails in Ensuring Data Integrity 

Audit trails and other metadata are rightfully given significant attention in regards to their ability to explain data and support its integrity. These records are generated by computerized systems and tell the story about how the data was collected and used. However, systems used in GxP regulated activities generate audit trails that span the spectrum in regards to their content, organization, and usefulness. They can range from meeting the bare minimum of regulatory requirements (or maybe less) to recording nearly every keystroke.  This session will explore the role of metadata in the data lifecycle and how it can be used to evaluate data for integrity. In addition, approaches towards reviewing metadata and audit trails will be discussed in order to more efficiently and effectively use these records.

IT Compliance

Level of Content:

H-2   SEND – from zero to a converted (outsourced) study – a case study 

The requirements to submit non-clinical data using the SEND standard are here and in force.
Guidance for business process implementation has been scarce and we’ve all been learning as we go.
This presentation explains the process that was followed by one company to be in a position to confidently provide a SEND converted study to a sponsor in a timely fashion.
We will walk through the process from the rationale to outsource, supplier selection, pilot tests through to a completed study and all the steps in-between.

IT Compliance

Level of Content:

H-3  What you need to know about GDPR! 

The EU GDPR will go into effect in May 2018 and will require businesses to focus on identifying and protecting sensitive personal data of EU Citizens. In this session, we will share practical insights for what, as a quality assurance professional, need to know about the regulation and what to look at during an audit to improve data governance, reduce the risk of data loss and ensure compliance.
We will discuss the following Points as they relate to the EU data protection regulation:
-The role of data classification in protecting critical data assets.
-Data security.
-Transfer of data outside the EU.
-Pseudonymizing / anonymization.
-Joint Controllers
-Data Protection Officer (DPO)

IT Compliance

Level of Content:

avatar for Joseph Whittemore

Joseph Whittemore

Sr Manager, Enterprise Records & Information Management, Pfizer
Joe Whittemore is a Sr. Manager, Enterprise Records & Information Management at Pfizer. In his current role, he manages the archival of inactive, electronic content across the enterprise. He has over 27 years of experience in the pharmaceutical industry. Throughout his career he has... Read More →

avatar for Vince D'Angelo

Vince D'Angelo

VP Global QA, Instem
Vince D’Angelo FRQA has worked in the pharmaceutical software industry for over 30 years, including over 20 years’ experience in Computer Systems Validation and is currently VP Global Quality Assurance at Instem plc, who provide pre-clinical and clinical software solutions as... Read More →
avatar for Joe Franchetti

Joe Franchetti

Managing Consultant, JAF Consulting, Inc.
As JAF Consulting Incorporated’s Managing Consultant, Joe Franchetti is an industry leader and teacher for Data Integrity, 21 CFR Part 11, Annex 11, and Computer System Validation in regulated environments. For over twenty-five years, Joe has been involved with the development... Read More →
avatar for Matt Hansen

Matt Hansen

Matt Hansen is the Senior Manager of R&D Labs Global QA Support at Covance and is responsible for providing quality assurance oversight for computer systems and electronic records. Mr. Hansen has over 12 years of QA experience in GxP environments, much of that time focusing on compliance... Read More →
avatar for Joanne Tyas

Joanne Tyas

Director Quality Assurance, ITR Laboratories Canada Inc.
Joanne Tyas is the Director of Quality Assurance at ITR Laboratories, a pre-clinical contract research organization in Canada. She has over 22 years of experience of working in a GLP environment. Throughout her career Joanne has worked on multiple computer validation projects and... Read More →

Tuesday April 10, 2018 3:30pm - 5:00pm PDT
Platinum 3&4