Data Integrity and Compliance With CGMP Guideline

Training Provider: Ngee Ann Polytechnic
Course Reference: TGS-2024051631
S$105
Original: S$350
Save S$245

About This Course

Data integrity lapses, such as uncontrolled access to computerized systems, non-contemporaneous record-keeping, and incidents of falsification or manipulation of data, represent a significant portion of regulatory citations in the pharmaceutical and biomedical industries. Given that data strategy is critical to the quality and reliability of processes, this course provides essential knowledge on data protection management and data breach incident management to safeguard company operations. By the end of the course, participants will be equipped to implement data integrity governance programs, enhance data security, and prepare for regulatory audits, safeguarding both the data and the processes that define pharmaceutical and biomedical manufacturing operations.

What You'll Learn

Participants will gain in-depth understanding of process quality management, quality assurance and audit, and the integration of technology infrastructure management with regulatory standards, ensuring compliance with Current Good Manufacturing Practice (cGMP) guidelines. Attendees will learn to develop data governance frameworks that support sustainable and compliant operations, while ensuring seamless integration of advanced systems for technology infrastructure management and integration.

Entry Requirements

Nil

Course Details

Duration 8 hours
Language English
Training Commitment Not specified
Total Enrolled New course
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Note: To apply for this course, visit the SkillsFuture website or contact the training provider directly.

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