New course!
Clear, concise, and unambiguous procedures and instructions are vital for minimizing human errors and ensuring smooth operations in any organisation. As organizations increasingly adopt AI and ML technologies, the ability to understand what effective Standard Operating Procedures (SOPs) and Work Instructions look like is critical.
We are excited to present a comprehensive virtual training session on crafting documents for excellence, designed to equip participants with the skills and tools required to create high-quality SOPs and Work Instructions. This training will feature a blend of instructional sessions, discussions, and case studies, ensuring that you gain practical knowledge and hands-on experience.
At the end of this session, attendees will:
1. Learn the importance of process mapping and flow charts as well as the human learning styles in generating SOPs, streamlining your operations and improving efficiency.
2. Master the art of writing well-structured SOPs by identifying their key features and compoents.
3. Gain a better understanding of the correlation between written information and its utilization by
AI/ML technologies, ensuring seamless integration optimization.
4. Draft example SOPs and Work Instructions, applying your new found skills in a practical context.
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 drafting and review of SOPs and Work Instructions. 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 31 May
ARCS member - $120
Non-member - $180
Standard - from 1 Jun
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)
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)
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