Start Date

19 March 2026

End Date

19 March 2026

Start Time

11:30

End Time

13:00

Venue

ARCS Virtual Classroom

Who Can Register?

Anyone

Topic 2 – Building foundations for Pharma 4.0- Data Governance and Data Integrity Practices

 

Overview: Adoption and implementation of digital technologies is no longer a nice to have in the life science sector. It has become a necessity. Regulatory authorities around the world have recognized the role and benefits of going digital and have started publishing several guidelines on the same. But successful implementation and subsequent effectiveness of digital tools rely on good data governance and management.

 

In this session, we will understand the concepts of data governance, management and integrity. We will also discuss the ALCOA principles, their practical applications and learn  simple tips to eliminate data integrity non-compliances.

 

Learning Objectives:

At the end of this session, attendees will:

1. Gain a foundational understanding of data governance, data management and data integrity.
2. Improve knowledge about the ALCOA principles & their application in both manual and electronic systems
3. Identify common reasons of recurring data integrity issues.
4. Learn about commonly cited data integrity & software implementation issues during inspections
5.  Get actionable strategies to improve compliance.

Who Should attend:

This training is for professionals working within the pharmaceutical, life science, clinical trials, and medical device sector. It is particularly beneficial for individuals who are responsible for regulatory compliance as well as those participating in the implementation of digital solutions. A prior basic knowledge of GMP document control will be useful, however, it is not mandatory.

Speaker:

Antiksha Joshi is an accomplished quality systems professional with over 20 years of experience in the pharmaceutical and life science industry. Throughout her career, she has demonstrated a strong commitment to ensuring compliance, efficiency, and excellence in quality management systems (QMS). With a passion for improving organizational processes, Antiksha has played a pivotal role in implementing and enhancing QMS at various organizations. Her expertise has been instrumental in leading successful regulatory audits and inspections, contributing to the overall success and reputation of the companies she has worked with. As the founder and leader of her consulting firm, Urmi Quality Management Consulting Pty Ltd, she is dedicated to supporting pharmaceutical and life science companies in achieving compliant, robust, and user-friendly quality systems. She also actively gives back to the community as a volunteer mentor for STEM students, inspiring and guiding the next generation of aspiring professionals in science, technology, engineering, and mathematics.  

Registration fees:

ARCS member - $180 +GST
Non-member - $255 + GST