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Wednesday, April 11 • 10:30am - 12:00pm
Session T - Roundtables Track

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T-1   Archiving Electronic Data – Black and White and Shades of Gray

​​​​Abstract:
Rapidly advancing technology seeking breakthroughs for treating diseases with medical devices, drugs, and combination products, requires access to  and increasing use of computerized systems in GLP studies. Data types run the gamut from proprietary software used for physiological monitoring,  advanced imaging systems data, clinical pathology data,  digital images (photographs and micrographs), and systems to collect comprehensive preclincal data sets just to name a few. The array of electronic data coupled with different system owners, server access limitations, varied data collection procedures, storage capacity, stability of media, and ability to read the data for the period required for retention are some of the challenges faced as electronic data becomes the norm. The Medical Device Specialty Section, Computer Validation Initiative Committee, and Scientific Archiving Specialty Section will discuss the issues and recommend best practices for archiving electronic data in compliance with 21 CFR Part 58 and Part 11.

Category:
Scientific Archiving

Level of Content:
Intermediate

Moderators
FR

Felice Randi LaMadeleine

Manager - Quality Assurance, Toxikon Corporation
Ms. LaMadeleine has over 25 years of experience in the medical device, pharmaceutical, industrial chemistry, and biotech industry, with the last 16 years in Quality Assurance. She joined Toxikon Corporation as a Data Reviewer/Auditor in 2000, then became a Quality Assurance Officer... Read More →

Speakers
avatar for Debra Bridges

Debra Bridges

GLP Consulting Services
Debra Bridges is President of GLP Consulting Services and former Associate Director of Operations and Regulatory Compliance for the Texas A&M Institute for Preclinical Studies. She has over 25 years of quality assurance, regulatory compliance, and combined research experience in industry... Read More →
avatar for Arif Demirel

Arif Demirel

Senior Manger, Archives, Charles River Labs
Arif Demirel is the Senior Manager of Archives at Charles River Laboratories and oversees the global archiving operations for Charles River. He has served in various roles, including reporting and GLP auditing. He is the current SASS chair and IACUC chair at Charles River - Horsham... Read More →
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 →


Wednesday April 11, 2018 10:30am - 12:00pm
Platinum 9&10

Attendees (34)