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The Annual Meeting program is subject to change. Speakers are added as confirmations are received.
Please  note that Quality College workshops require separate registration.

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Monday, April 9 • 1:00pm - 5:00pm
Workshop 11 - GLP 203: Intermediate GLP Archiving (1/2 day)

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RQAP re-registration units: 1 GLP, non-GCP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Description
This course will provide participants with a detailed overview of archiving and the regulatory landscape.

Objectives
At the end of the course, the participants shall be able to: 
  • Identify GLP risk areas in an archive
  • Develop a robust chain of custody process for the transfer of archived material
  • Provide value to his/her site by educating internal and external clients on archiving requirements

Target Audience
Archiving 201 is targeted for seasoned archivists with a more detailed look at the regulatory landscape and agency expectations.

Agenda
  • 1:00-1:10 Welcome, Logistics and Introductions
  • 1:10-1:15 Regulatory Landscape
  • 1:15-2:15 My archive is moving. What should I do and expect?
  • 2:15-3:00 Records Management - A corporate approach
  • 3:00-3:15 Beverage break
  • 3:15-4:30 Electronic Archiving
  • 4:30-5:00 Q&A and Wrap up

Speakers
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 Kathryn Newland

Kathryn Newland

DSRD Global Compliance & Records Management Lead, Pfizer
Kathryn Newland is the Global Compliance & Records Management Lead with Regulatory Strategy and Compliance in Drug Safety Research & Development at Pfizer, Inc. Her responsibilities include leadership and management of the combined Compliance & Records Management organization, setting... Read More →
avatar for Thomas Purdue

Thomas Purdue

QA Compliance Analyst V, Boehringer Ingelheim Pharmaceuticals, Inc
Mr. Purdue is a Registered Quality Assurance Professional in GLPs (RQAP-GLP) and has over 25 years of experience in performing GLP audits of facilities and studies to comply with U.S. FDA, EPA, European, and Japanese GLP regulations. He has 10 years’ experience in GMP Quality Assurance... Read More →

Monday April 9, 2018 1:00pm - 5:00pm PDT
Platinum 10
  QC Workshop, QC Workshop - 1/2 Day - PM

Attendees (7)