This Event has Passed
Tuesday, February 25, 2020
1:00 PM - 2:00 PM
1:00 PM - 2:00 PM See all dates and Times
http://bit.ly/30NjtJa
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.
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.
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
• 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
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
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.
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
• 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
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
