A16. Fundamentals of Digital Transformation
Tracks
GMP/Manufacturing
Wednesday, June 12, 2024 |
2:45 PM - 3:45 PM |
C2.5+C2.6 |
Chair & Speakers
Antiksha Joshi
Director
Urmi Quality Management Consulting Pty Ltd
Chair: Fundamentals of Digital Transformation
Biography
Antiksha Joshi is an accomplished quality systems professional with over two decades 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 & simplifying organizational processes, Antiksha has played a pivotal role in implementing and enhancing QMS at various organizations (big & small). 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
Ian Lucas
Director/training Manager
SeerPharma Pty Ltd
Preparing for Industry 4.0
Biography
Ian has over 35 years of experience with software development and implementing computerised systems. He has successfully designed and implemented many quality management and manufacturing solutions for the pharmaceutical industry and other regulated industries. Ian manages the Training Department and also works closely with customers to deliver fully validated customer-focused automated solutions.
Recently, Ian has been educating the industry on Industry 4.0 concepts, processes and technologies.
Ian regularly presents training courses and seminars on practical approaches to computer validation.
Dr Robert McDowall
Director
R.D.McDowall Limited
Digital Transformation - A case study of Quality Control Laboratory
Biography
Bob McDowall is an analytical chemist with over 50 years’ experience including 15 years working in the pharmaceutical industry and over 30 years’ working for the industry as a consultant. Bob has been involved with the automation of laboratories and validation of computerised systems for over 35 years. He edited the first book on Laboratory Information Management Systems (LIMS) in 1987 and is the 1997 LIMS Awardee. Bob is also is the author of two editions of a book on the validation of chromatography data systems and one on data integrity and data governance for regulated laboratories. He writes the Questions of Quality column for LCGC International and Focus on Quality column for Spectroscopy. Bob was a subject matter expert input and review contributor to the GAMP Records and Data Integrity Guide and two of the data integrity Good Practice Guides.