Implementation and Management of GMP Data Integrity
Training
Online
*Indicative price
Original amount in USD:
$ 150
Description
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Type
Training
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Level
Advanced
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Methodology
Online
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Class hours
2h
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Duration
1 Day
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Start date
October
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Virtual classes
Yes
Data Integrity , and discover the Criteria for Data Integrity, and also learn about approaches to improve Data Integrity in a Laboratory Environment.
Facilities
Location
Start date
Start date
Reviews
Subjects
- Compliance Trainings
- Healthcare
- Medical courses
- Online Trainings
- Compliance education
- Industrial courses
- Technical courses
- Fda inspections
- Knowledge
- Financial updates
Teachers and trainers (1)
Adam Fleming
Event Manager
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. . Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements.
Course programme
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.
Areas Covered in the Session:
- 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
Additional information
Implementation and Management of GMP Data Integrity
*Indicative price
Original amount in USD:
$ 150