Data Integrity for the Laboratory and Beyond - Careful Considerations for Your Next Audit
from Armaya SmithOVERVIEW
Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both.
To assure the quality of raw materials, in process materials and finished goods, laboratory data integrity is assuming greater importance in current Good Manufacturing Practices (CGMP) for US Food and Drug Administration (FDA)-regulated industry. Data integrity and security infractions are not only 21 Code of Federal Regulations (CFR) Part 11 issues but also severe CGMP violations.
The reasoning behind this complex issue is quite simple: if the integrity of laboratory data is compromised, batches of finished goods may not comply with regulatory authorization terms and, consequently, will not be released for sale.
WHY SHOULD YOU ATTEND
In recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections. This is troubling because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs, biologics and medical devices.
These data integrity-related CGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees. Attendees will obtain an understanding of the regulatory expectations for data integrity compliance.
AREAS COVERED
• Understand the current regulatory position on data integrity
• Discover the criteria for data integrity
• Recognize what needs to be addressed to ensure data integrity within a regulated GXP laboratory
• Learn about approaches to data integrity risk assessment
• Learn about approaches to improve data integrity in a laboratory environment
LEARNING OBJECTIVES
The information provided at the webinar will enable the attendees to review practices at their own site and identify gaps in their own practices for maintaining data integrity compliance.
WHO WILL BENEFIT
• Site Quality Operations Managers
• Quality Assurance personnel
• Plant Managers and Supervisors
• Manufacturing Superintendents and Managers
• Regulatory Affairs Managers
SPEAKER
Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet regulatory compliance.
To Register (or) for more details please click on this below link:
http://bit.ly/30ZhEt3
Email: [email protected]
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882 (from )
-
This event has passed.
February 25, 2020 from 1:00 to 2:00 pmFebruary 25, 2020 01:00 to February 25, 2020 02:00 -
26468 E Walker Dr, Aurora, Colorado 80016
26468 East Walker Drive, Aurora, CO -
Contact Training Doyens for more information
+1-720-996-1616 or [email protected] -
This listing has not been linked to an event on Facebook.
Suggest a Facebook event for this listing
Directions are calculated based on the address provided by the event submitter and may not be precise. Please contact the event coordinator for more detailed information.