Data Integrity Compliance and Key to Reduce Data Integrity Violation Trends
Information
Data integrity is of utmost importance in any CGMP pharmaceutical manufacturing setting now more than ever. Data integrity guidance may not be a new concept but there is increased scrutiny of data integrity and compliance matters are on the rise. This session will benefit manufacturers who are trying to attain a high degree of data integrity, benchmarking regional manufacturers, and this is an open forum to encourage discussions for effective implementation and outlining robust strategies.
This session is sponsored and chaired by NNIT.
Chairperson’s Opening Remarks
Sudjati Rahardjo, Principal Consultant, NNIT Singapore
15:00-15:20
Data Integrity Compliance and Key to Reduce Data Integrity Violation Trends
Hosted by:
Shantha Kumara, Quality Assurance Manager, Strides Pharma, Singapore
15:20-15:40
Statistical Techniques for Product Quality Improvement & Monitoring
You will learn:
Importance of applying statistical thinking to quality improvement
Overview of practical and simply statistical methods used for quality improvement
Practical and statistical considerations when choosing a statistical method to use
Hosted by:
Md. Zakar, Executive Director, Plant Operations, NIPRO JMI Pharma Ltd., Bangladesh
15:40-16:00
Developing a Robust Quality System to Assure Data Integrity
You will learn:
Regulatory trends and guidance in Philippines’ pharma industry
How data integrity and process monitoring are critical to each other for regulatory compliance
Link between data integrity and quality culture
Remaining pain-points in data integrity
Hosted by:
Cloyd Lambojon, Supervisor Production / Site Data Integrity Lead, GSK, Philippines
16:00-16:30
Q&A with the Hosts – Chaired by NNIT
Moderator:
Sudjati Rahardjo, Principal Consultant, NNIT Singapore
Speakers:
Shantha Kumara, Quality Assurance Manager, Strides Pharma, Singapore
Md. Zakar, Executive Director, Plant Operations, NIPRO JMI Pharma Ltd., Bangladesh
Cloyd Lambojon, Supervisor Production / Site Data Integrity Lead, GSK, Philippines
