10 Sure-Fire Tips for Implementation and Management of GMP Data Integrity Any Investigator Would Love
01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes
Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar
"Danielle DeLucy Owner, ASA Training and Consulting, LLC"
Understanding of the regulatory expectations for Data Integrity
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 CGMP for US FDA regulated industry. Data integrity and security infractions are not only 21 CFR Part 11 issues but also severe CGMP violations.
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.
In this webinar attendees will obtain an understanding of the regulatory expectations for Data Integrity. The information provided at the webinar will enable the attendees to review practices at their own site and identify gaps in their own practices.
• 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 improve data integrity in a laboratory environment
• Part 11 compliance
• FDA citations related to data integrity issues
• And much more !
Who will Benefit
The following professionals from FDA regulated industries will benefit from this training:
• Site Quality Operations Managers
• Quality Assurance personnel
• Plant Managers and Supervisors
• Manufacturing Superintendents and Managers
• Regulatory Affairs Manager
Industries who can attend
This 90 minute online course is intended for professionals in the Pharmaceutical and Biopharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel