Foundations of GMP: Data Integrity and Computer System Validation
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Course Description
This eLearning course aims to improve your knowledge and understanding of Good Manufacturing Practice (GMP) requirements of computer system validation and data integrity.
Upon completion of this course, you will be able to:
- Understand the data integrity regulatory requirements
- Explain the ALCOA+ principles
- Understand the computer system validation process including policies and procedures, roles and responsibilities, training, supplier management, planning and continuous improvement
Applies to the following audiences
- Manufacturing organizations
- GMP auditors and trainers
- Regulatory professionals and Inspectors
- Students in pharmacy related degrees
Access Duration: Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
Price: $0.00
USPEDU Course ID: GMP-EL-07
Available Languages: English (US)
Version:1.0
Subjects: current Good Manufacturing Practice (cGMP)
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Why Choose USP Education?
USP Education provides year-round courses and programs on how to effectively interpret and apply USP’s internationally recognized quality standards. The standards help ensure the quality and safety of medicines, dietary supplements and foods. USP courses are created by the scientists and experts who help develop the USP standards that are used worldwide. Courses are presented by approved instructors with practical, first-hand knowledge of the subject area and related standards. The insights they share will not only make your daily work easier, but will also connect you to an independent, nonprofit scientific body with the goal of creating a strong foundation for a healthier world.
Content source: U.S. Pharmacopeia - Image courtesy: geralt via pixabay.com
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