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Tuesday, April 21, 2020
1:00 PM - 2:00 PM
1:00 PM - 2:00 PM See all dates and Times
https://bit.ly/2yb07DJ
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OVERVIEW 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.
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.
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
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
Use Promo Code TDES20 and get flat 20% discount on all purchases.
To Register (or) for more details please click on this below link:
https://bit.ly/2UAFUyB
Email: [email protected]
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882
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.
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
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
Use Promo Code TDES20 and get flat 20% discount on all purchases.
To Register (or) for more details please click on this below link:
https://bit.ly/2UAFUyB
Email: [email protected]
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882