Topic 1 – Quality Management Systems & GxP– Foundations for Compliance and Operational Excellence
Overview: In the past couple of years, regulatory expectations around holistic quality management have seen an increase. New & updated regulatory guidelines have repeatedly used the phrase overall quality management. Combine these expectations with a volatile life science ecosystem, and it is clear that life science organizations need to change their mindset from “compliance only” to “quality always”.
In this virtual training session, we help you understand what holistic quality really means, and the steps involved in implementing a quality system that helps achieve not just regulatory compliance but also improve operational efficiencies. Using real world examples and case studies, we will understand the difference between a quality and compliance mindset and how the two can be leveraged together to improve operations as well as regulatory compliance.
Learning Objectives:
At the end of this session, attendees will:
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Gain a deeper understanding of the similarities and differences between Quality Management System (QMS) and GxP
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Identify the different quality tools that can be leveraged for improving quality & compliance.
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Learn how to implement a holistic quality approach within your organization.
Who Should attend:
This training is for professionals working within the pharmaceutical, life science, clinical trial and medical device sector including senior managers, quality & operations managers as well as those interested in improving organizational quality practices and processes. This session is also suitable for STEM graduates looking to work within the regulated industry and wanting to gain foundational knowledge of QMS.
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
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