Integrity of Quality and the Quality of Data Integrity
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Overview
Product quality is fundamental in regulated industries such as the pharmaceutical, food, and cosmetics industries. Furthermore, the proof of quality depends on reliable data.
Not maintaining healthy data reliability (Data Integrity) can lead to a rough consensus with regulators.
Health authorities have written methodical official guidelines, such as 21 CFR Part 11, to ensure that manufacturers present them with reliable and accurate data to justify their decision-making. And since 2013, the authorities have been updating other core guidelines to focus on Data Integrity more than ever before.
Although the requirements are loud and clear, we still find that the managers in charge of deploying the principles face challenges that arise from multiple gray areas.
Therefore, Data Integrity training became mandatory for any organization committed to this subject.
In this webinar, we will explore ways to implement Data Integrity principles within the organization fundamentally and use them as internal training.
We will discuss the principles represented by ALCOA(+), which you can also apply to everyday decisions. As such, it strongly relates to the organizational quality culture and the successful deployment of quality processes.
The webinar includes a historical overview of the development of the requirements and Data Integrity principles dealing with maintaining the quality and reliability of data.
It includes a comparison of the various regulations, as well as recommendations for the successful implementation of a shared organizational culture.
By the end of the webinar, you will be able to explain and account for the rationale behind the required Data Integrity regulations.
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Who Should Attend:
Quality Professionals
- Skill Level: Novice, Intermediate , Expert
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Topics:
1. Quality Culture for Data Integrity
2. Regulatory Update - Diving into Data Integrity basic aspects
3. Validation as continuous improvement -
Special event information:
A complimentary certificate of attendance will be available for all attendees, courtesy of our sponsor, Qualio.
Speaker
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Galit LisaeyData Integrity ConsultantGalit Lisaey is a Data Integrity Consultant who helps organizations
implement reliable, tailor-made, and accurate tools to meet Data
Integrity standards.
With 20 years of experience as Information Technology Project
Manager and CSV Expert.
Galit Lisaey established Gal.IT Data Integrity Consulting, out of the
realization that many organizations lack the understanding of the
need for Data Integrity support unit. The goal is to help them
implement this activity through an in-house unit.The contents of her lectures and courses over the years contribute
greatly to helping organizations to meet this requirement.
Partner
Qualio
Website
https://qualio.com/Founded in 2012, Qualio is the first cloud quality management software for all Life Sciences companies. Medical device and pharmaceutical companies need a secure and scalable quality management system with the flexibility to support their evolving needs. Qualio meets that challenge by cutting through the complexity to optimize and automate critical quality processes. The remote-first, Qualio team is distributed across North America and Europe.
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