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
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Course Date: TBC
Application Period: TBC
Duration: 1 day
Time: 9am to 6pm
Delivery Mode: Classroom
Venue: TBC
This course may be conducted online subject to Covid-19 guidelines.
Ngee Ann Polytechnic reserves the right to reschedule / cancel any programme, modify the fees and amend information without prior notice.
Lesson Plan
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
Certification
A Certificate of Performance will be awarded to participants who achieve at least 75% attendance and pass all required assessment(s).
Entry Requirements
Course Fees
Course fee is payable upon acceptance. It is inclusive of 7% GST and subject to review.
Funding period for this course is from 7 Aug 2020 to 30 Sep 2024.
SkillsFuture Credit
All Singaporeans aged 25 and above can use their $500 SkillsFuture Credit from the government to pay for a wide range of approved skills-related courses. Visit the SkillsFuture Credit website to choose from the courses available on the Training Exchange course directory.
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.
Enhanced Training Support
For enhanced training support, enter SME in the promo code during course application.
Ngee Ann Polytechnic reserves the right to reschedule / cancel any programme, modify the fees and amend information without prior notice.
| Applicants / Eligibility | Fees |
|---|---|
| Full course fees after GST | $374.50 |