Data Integrity and Compliance With cGMP Guidance

Short Course / 1 day

Course Information
Learning Outcomes
Course Schedule
Lesson Plan
Certification
Course Fees

Course Information

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.

While a few of the lapses are intentional, many are unintentional and reflect a poor understanding and poor implementation of a data integrity system. Data is the fingerprint of the company’s processes and products.

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.

This course will be relevant to all persons responsible for quality in the pharmaceutical or biomedical manufacturing industry; including persons involved in quality assurance, quality control, documentation, inspection and auditing, process development and manufacturing.

Learning Outcomes

  • 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 
Schedule

Course Date: 17 April 2021
Application Period: 1 March to 1 April 2021
Duration: 1 day
Time: 9am to 6pm
Ngee Ann Polytechnic reserves the right to reschedule/cancel any programme, modify the fees and amend information without prior notice.

Lesson Plan

This course consists of 1 modules:

Course participants working in the pharmaceutical / biomedical industry will gain an insight into the data integrity requirements and regulatory expectations, which will enable them to implement data integrity governance systems, methodologies and programmes to avoid data integrity lapses.

Certification

A Certificate of Performance will be awarded to participants who achieve at least 75% attendance and pass all required assessment(s).


Course Fees

Course fee is payable upon acceptance. It is inclusive of 7% GST and subject to review.
The course is eligible for SkillsFuture Credit. For more information on the SkillsFuture Credit click here.
For enhanced training support, enter SME in the promo code during course application.

Union Training Assistance Programme (UTAP)
NTUC members enjoy 50% unfunded course fee support for up to $250 each year (or up to $500 for NTUC members aged 40 years old and above) when you sign up for courses supported under UTAP (Union Training Assistance Programme). Please visit e2i’s website to find out more.

Applicants / Eligibility Fees
Full Course Fee$374.50
Singaporeans and Permanent Residents$112.35
Singaporeans qualified for SkillsFuture Mid-Career Enhanced Subsidy$42.35
Singaporeans and Permanent Residents qualified for Enhanced Training Support for SMEs$42.35