New course!
As the healthcare product development and manufacturing industry embarks on its digital transformation journey, the role of data has become more crucial than ever. Good data forms the bedrock for successful technology adoption and regulatory compliance. While expectations around good documentation practices and data integrity have been in place for years, their significance and implementation have gained new depth in today's landscape.
We are delighted to present an insightful virtual training session on Data Integrity and Good Documentation Practices, designed to help you understand their importance and provide practical insights on how to fortify these aspects across your organization. This session will equip you with the knowledge and tools needed to build a strong foundation for effective digital transformation in healthcare product development and manufacturing. Real-world examples including regulatory trends will help clarify the concepts.
At the end of this session, attendees will:
1. Gain a better understanding of data integrity and good documentation practices and their role in digital transformation.
2. Learn practical tips and strategies to strengthen data integrity and good documentation practices across your organisation.
3. Discover simple, everyday matters that can lead to data integrity issues and how to avoid them.
4. Engage in interactive discussions with indistry experts and peers, sharing best practices and lessons learned
This training is for professionals working within the pharmaceutical, life science, clinical trials, and medical device sector. This session is applicable to those working in GMP, Regulatory Affairs, Medical Devices, Pharmacovigilance, Medical Operations, Clinical Research or Quality. 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.
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 19 Apr
ARCS member - $120
Non-member - $180
Standard - from 20 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.
Quality Management Systems – General Principles and Implementation
29 April - 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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