Data integrity lapses, eg lack of control over access to computerised systems, non-contemporaneous record keeping, deletion, falsification, alteration or other manipulation of data, have often been cited in regulatory audits of pharmaceutical / biomedical companies. Some of the lapses are intentional but many are unintentional. As data is the fingerprint of the company’s processes and products, it is paramount that all employees working in the pharmaceutical / biomedical industry understand what data integrity is in order to avoid data integrity lapses.

Objective

This is an interactive 1 day workshop that aims to equip participants with a good knowledge and understanding of data integrity as it pertains to the pharmaceutical / biomedical industry. There will be case studies to help participants internalise the learning and apply what they have learnt to identify and reduce / eliminate data integrity issues.

The workshop will cover :
- Explanation of what data integrity is
- Explanation of why data integrity is important
- Regulatory requirements of data integrity
- Barriers to data integrity
- Ways to reduce data integrity issues

Case Studies throughout the workshop for the participants to internalise the learning through :
- Identification of the data integrity lapses
- Identification of the causes for these lapses
- Identification of correct approaches

Who should attend

This workshop is suitable for QA, QC, production and other associates working in the pharmaceutical, biomedical industry and anyone else who may be interested in data integrity. It is also important for anyone moving into the pharmaceutical / biomedical industry as data integrity is core to the industry.

Methodology

Agnes Lim's Profile

Armed with a BSC (Hons) from the National University of Singapore, a MBA from the University of Hull and an Advanced Certificate for Training and Assessment (ACTA) by Institute of Adult learning (IAL), Agnes Lim has more than 30 years of corporate experience in the biomedical industry of which 20 years were in middle and senior management.

Adept at people management, she has more than 20 years experience in hiring, managing, training and developing staff and more than 10 years experience in succession planning at the site leadership level. She is able to connect with people across different levels in the organisation having worked up the levels in her career. She has conducted more than 300 interviews ranging from junior management staff to site leadership team members to scholarship aspirants at her previous companies.

Being in a technical department, Agnes is equally well versed in technical report writing and technical presentation, having created and reviewed many thousands of technical reports and presentations throughout her career.

Agnes has developed and conducted numerous trainings and coached learners on both technical and soft skills. Examples of trainings that she has conducted include, How Managers and supervisors can Develop Career of their Staff, Hire Right, Managing your Career Development for Success, Technical Writing Skills, Technical Presentation skills, Auditing Skills, Investigations Skills, Data Integrity, Quality Risk Assessments amongst others.

A comfortable and confident speaker, she was invited to speak at BioBiz at NUS previously to help the students have a better understanding of the career opportunities in the biomedical / pharmaceutical industry. She has also shared her educational choices with students at Raffles Girls School (Secondary), her alma mater.

Agnes is passionate about developing and cultivating talents within the organisation. She believes that a keen focus on talent development differentiates organisations and is a competitive advantage.

With a passion for youth and education, she currently volunteers with ACTS Singapore.