Sponsoring and Speaking at the 2019 SQA Annual Meeting
By jamiemorris,
This post was recently updated on June 17, 2020
We are excited to be returning as a sponsor at the 2019 SQA Annual Meeting in Atlanta, GA next month. If you are attending this conference, stop by our booth. Our team would love to meet you and answer any of your software quality assurance or computer system validation questions.
Visit us in Booth #309.
Additionally, Deb Bartel will be speaking during the conference. Read more about her session below:
Topic: Lessons from a Data Integrity Auditor
Session W
Date: Wednesday, May 1, 2019
Time: 8:30 AM – 10:00 AM
Room: Marquis B
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 seen the need to publish additional documents in the last few years to address widespread data integrity issues.
By now many Quality Assurance and IT 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. But when it comes to implementing these principles, it can be challenging to know where to start.
Although each GxP organization is working from the same framework of FDA, EMA, MHRA, WHO, and PIC/S guidelines, implementation strategies vary greatly. Auditors see the best approaches to implementing the ALCOA principles; and, auditors also see the worst approaches.
This presentation will share details of 10 critical areas to include in a data integrity compliance program:
- Security and User Access
- Audit Trails
- Back-ups
- Record Storage
- Record Copies
- Validation
- Issue Investigation
- Out-sourced Services
- Out-sourced Systems
- Training
Then, Deb will share examples of best practice (and a few worst practice) implementation approaches in each of the 10 areas to minimize data integrity vulnerabilities, as learned in data integrity audits over the past 3 years.
Key Takeaways
- Awareness of 10 critical areas to address in your data integrity program
- Best practice approaches to minimize data integrity vulnerabilities
- Ineffective approach to addressing data integrity
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, medical device, research, healthcare, and software industries. Her expertise is in building practical, effective approaches to meeting quality and compliance challenges by utilizing LEAN, continuous improvement, and risk-based processes. She has over thirty years of experience leading quality assurance, validation, and technology initiatives. Deb has BS-Information Systems and MBA degrees from the University of Wisconsin.
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