New course!
In the rapidly evolving landscape of healthcare product development and manufacturing, the post-pandemic era has brought about unprecedented challenges and opportunities. Businesses of all sizes and operational scopes are now required to adapt swiftly to ever-changing requirements, all while maintaining unwavering product quality and patient safety. To thrive in this new environment, companies must embrace holistic approaches to manage their business operations effectively.
The journey to mastering these new dynamics, integrating technology, and overcoming the challenges of supply chain and workforce dynamics, begins with a holistic approach to your business operations. It's time to transcend traditional boundaries and harness the power of comprehensive quality management systems (QMS). Achieving regulatory compliance, operational excellence, and unwavering customer satisfaction is no longer an aspiration—it's a necessity.
Our virtual session is designed to support you in this transformation journey. Our expert combines the principles & tools from the ISO 9001 as well as the regulatory quality systems to show what holistic quality approach looks like. The session will highlight how these principles are not just theories, but actionable strategies that can move your company towards regulatory compliance, operational excellence and customer satisfaction.
At the end of this session, attendees will:
1. Gain a deeper understanding of QMS and how it applies to their organization.
2. Understand the core elements of a QMS.
3. Learn how to implement an effective QMS within their organization.
4. Hear real-world case studies of successful QMS implementation, including challenges and solutions.
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. The course is applicable to those working in GMP, Regulatory Affairs, Medical Devices, Pharmacovigilance, Medical Operations, Clinical Research or Quality. This session is also suitable for STEM graduates looking to work within the regulated industry and wanting to gain foundational knowledge of QMS.
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.
Course fees (incl. GST):
Early bird - until 1 Apr
ARCS member - $120
Non-member - $180
Standard - from 2 Apr
ARCS member - $150
Non-member - $225
This course is one of a four-part series. To see other sessions in this series, please use the links below. Receive a 20% discount when registering for the entire series: click here.
Building strong foundations for Digital transformation: Good Documentation and Data integrity practices
17 May 10:30-12:00 (AEST)
Document Management and Control
7 June - 10:30-12:00 (AEST)
Writing effective and compliant SOPs and work instructions
28 June - 10:30-12:00 (AEST)
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