New course!
Documents and data are not only the backbone of compliance in the regulated industry but also a tool for building customer confidence and trust. As global collaborations expand and companies adopt digital technologies, it is vital to comprehend the true meaning of documents and records and how they are controlled.
We are excited to present a comprehensive virtual training on Document Control for Regulatory Compliance, designed to help participants grasp the concepts and documents and their control. This training will provide valuable guidance on manual, electronic, and hybrid document management systems, ensuring that you are well-equipped to navigate the complexities of the industry.
At the end of this session, attendees will:
1. Gain a deeper understanding of the document hierarchy,its management, and various stages of the document life cycle
2. Learn about regulatory requirements surrounding document management and how to ensure compliance.
3. Discover best practives for managing manual, electronic, and hybrid document management systems.
4. Engage in interactive discussions and explore real-word case studies of document management 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 understanding document management or working on introducing electronic Document Management Systems. This session is applicable to those working in GMP, Regulatory Affairs, Medical Devices, Pharmacovigilance, Medical Operations, Clinical Research or Quality.
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 10 May
ARCS member - $120
Non-member - $180
Standard - from 11 May
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)
Good Documentation Practices and Data Integrity
17 May 10:30-12:00 (AEST)
Writing Effective and Compliant SOPs and Work Instructions
28 June - 10:30-12:00 (AEST)
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