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Wednesday, April 11 • 1:30pm - 3:00pm
Session W - I.T. Compliance Track

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W-1  Electronic Data Integrity – Take Action Now

Part 11, Annex 11, and similar regulations have been in place for years to ensure electronic data integrity.  However, the FDA, EMA, MHRA, WHO, and PIC/S have all seen the need to publish additional documents in the last few years to address widespread data integrity issues.
By now many IT and Quality Assurance professionals at GMP, GCP, and GLP compliant organizations are familiar with the acronym ALCOA and know that the ALCOA principles are the keys to data integrity.  They might even be participating in Data Integrity compliance assessments, much like the Part 11 compliance assessments of a few decades ago.  But, what actions will be the outcome? And, can these actions start now?
The answer is ‘yes’.  Unlike the Part 11 compliance initiatives of the 1990s, many actions required to address data integrity vulnerabilities can be addressed without expensive computer system replacement programs.
This presentation will describe actions that organizations can take now to prevent or remediate electronic data integrity gaps in the following 10 critical areas:  security and user access, audit trails, back-ups, record storage, record copies, validation, issue investigation, out-sourced services, out-sourced systems, and training.
And, since much can be learned from FDA Warning Letters about what not to do, we will look at examples of sometimes common and sometimes surprising data-integrity compromising practices that have been cited in the last 2 years.

IT Compliance

Level of Content:

W-2  Do You Really Know What Records You Have? 

One of the primary objectives of a sound records management program is defensible disposition of unstructured electrconic content that has met retention requirements. The challenge often lies with clearly identifying and classifying the content that is, or needs to be, archived. In today's digital world, electronic content is far surpassing physical content which results in storage of records that are duplicative, obsolete, and/or not appropriately classified. This is particularly true following a merger or acquisition when you 'inherit' large volumes of unknown content that must be stored. Now knowing the true nature of the content results in long-term storage of records for far longer than may be required. However, a manual review of large collections of electronic content is not feasible. The goal of this presentation will be to provide a review of an Auto-Classification Proof-of-Concept project that we recently completed.

Scientific Archiving

Level of Content:

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 →

avatar for Deb Bartel

Deb Bartel

Praxis Life Sciences
Deb Bartel is a Partner at Praxis Life Sciences where she is responsible for the company’s Computer System Validation (CSV) and Software Quality Assurance (SQA) practice.  Since becoming a part of Praxis in 2007, she has provided guidance to clients in the pharmaceutical, biotech... 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 1:30pm - 3:00pm PDT
Platinum 3&4