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Advances & New Frontiers in Sterile Manufacturing Technology

17th & 18th April 2020, Mumbai, India

AUTOMATION IN STERILE PROCESSING

Ganadhish Kamat Global Head Quality & Executive Vice President, Dr. Reddy's Laboratories

Mr. Kamat will talk about how Automation can help in Sterile Processing. He will also share the challenges faced, lessons learned and how automation has helped the company achieve excellence 


Ganadish Kamat is currently Global Head of   Quality & Executive Vice President at Dr. Reddy's Laboratories and has   30+ years of experience in leadership roles in the pharmaceutical industry in   various leading Indian and International companies in India and the US. 


Mr. Kamat holds a Master's degree in   Pharmacy and a Diploma in Business Management. 

He is a member of the International Society for Pharmaceutical Engineering (ISPE), the expert committee of Indian Pharmacopoeia and the Quality Forum of the Indian Pharmaceutical Association (IPA). 

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the Monitoring of a Sterile Manufacturing Environment

Data Management throughout the Monitoring of a Sterile Manufacturing Environment

During this presentation we will discuss:

  • Types of data generated on the manufacturing floor and in the lab
  • Data Lifecycle for the types of data generated
  • Criticality of the data – Reportable data vs Informational
  • Data strategy for removing paper from the process associated with the raw material handling, manufacturing process and laboratory handling of the samples
  • Integrity of the data generated through the process
  • How do you select and implement systems that will maximize the value of your data and successfully execute on all of these various priorities?
  • Can you navigate moving from a paper based or out dated system to newer technologies?

Attendees will be able to evaluate the existing data processes and systems in their facilities and understand the steps needed to bring the facility up to date, while recognizing that these improvements can provide a tangible benefit, rather than simply a cost.

Ultimately, what is the value of your data?

Rob Lutskus is a subject matter expert on laboratory informatics within quality control for the bio-pharmaceutical industry. Currently, Associate Director, Commercial Operations for Lonza Bioscience Informatics.

Rob has worked in QC laboratories and Laboratory Informatics for almost 20 years, originally a QC microbiologist; Rob has worked for Merck, Hoffman La Roche and Baxter before joining ImClone Systems in Branchburg, NJ.   In 2007, Rob led the original implementation of MODA EM™ as a custom solution.  The custom solution was upgraded to the first release of the commercial solution, shortly after.  He joined Lonza in 2010.  Since joining Lonza he has worked with numerous quality organizations to implement best practices while executing their MODA-EM™ projects.   Rob is an active member in a variety of industry organizations, including the Parenteral Drug Association and ISPE.  He is also a contributing author to Environmental Monitoring: A Comprehensive Handbook, Volume 3.

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