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. Some 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
Monday, 9:00 am to 5:00 pm
XXX, 9am to 5pm
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
| Applicants / Eligibility | Fees |
|---|---|
| Singapore Citizens (SC) below the age of 40 years | $112.35 |
| Singapore Citizens (SC) aged 40 and above | $42.35 |
| Singapore Permanent Residents (PR) | $112.35 |
| Enhanced Training Support for SME Scheme (for SC & SPR) | $42.35 |
| Others (and Repeat Students) | $374.50 |
| Full Course Fee (Before GST) | $350.00 |