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[NP-DIC-F] Data Integrity and Compliance With CGMP Guideline

Offered by School of Life Sciences & Chemical Technology

Certifiable Courses

About Course
Course Structure
Financial Matters
Register Interest
Area of interest
Biomedical Manufacturing, Engineering

About Course

Course Objectives

Data integrity lapses, including the lack of control over access to computerised systems, non-contemporaneous record keeping and deletion, falsification, alteration and manipulation of data, constitute a significant fraction of cited in regulatory audits of pharmaceutical/biomedical manufacturing companies. Some of the lapses are intentional. Many are unintentional reflecting a poor understanding and poor implementation of data integrity systems.

As data is the fingerprint of a company’s processes, it is paramount that all employees working in the pharmaceutical / biomedical industry understand what data integrity is in order to prevent data integrity lapses.
This course will provide details of the data integrity requirements and regulatory expectations to enable implementation of required data integrity governance systems, methodologies and programmes.

Course Description

- Data integrity
- Regulatory requirements of data integrity
- Identification of data integrity lapses
- Causes for the lapses
- Identification of the corrective actions
- Identification of barriers to data integrity
- Ways to reduce data integrity issues

Course Structure

TPG course reference No.

TGS-2024051631

Data Integrity and Compliance With CGMP Guideline
Data Integrity and Compliance With CGMP Guideline (NP-DIC-F)

Financial matters

Course fees payable (incl. GST & excl. supplementary fee)

Description Data Integrity and Compliance With CGMP Guideline Total course fee
Full Course fee $381.50 $381.50
Enhanced Training Support for SMEs for Singapore Citizen $44.45 $44.45
Enhanced Training Support for SMEs - SPR & LTVP+ $44.45 $44.45
SkillsFuture Mid-Career Enhanced Subsidy for Singapore Citizen aged 40 and above $44.45 $44.45
SkillsFuture Baseline Funding for Singapore Citizen Aged Below 40 $114.45 $114.45
SkillsFuture Baseline Funding for SPR/LTVP+ $114.45 $114.45

GST rate

The course fees payable above are inclusive of 9% GST rate.

Payment option

The payment needs to be made upon the application is submitted.

Allowed payment by

Post-Secondary Education Account (Adhoc withdrawal form);Post-Secondary Education Account (Standing order form);SkillsFuture Credits (SFC);Credit card (e-payment);Debit card (e-payment);PayNow (e-payment)

Refund and withdrawal policy

  • Please note that a 100% refund will be available if the withdrawal request is submitted more than or equal to 14 days before the course start date.
  • Please note that a 50% refund will be available if the withdrawal request is submitted less than 14 days before the course start date.
  • Please note that no refund will be available if the withdrawal request is submitted on or after the course start date.