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Quality, Regulatory, Operations Speaker Series (hosted by the PDA at KGI)

Friday, November 9, 2012 from 1:00 PM to 2:30 PM (PST)

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Quality, Regulator, and Operations Speaker Series Ended Free  

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Event Details

The student PDA chapter at KGI is proud to be hosting our first industry event of the year. We have 3 distinguished guests from Medtronic, Amgen, and Gilead visiting KGI to give a presentation about their careers and respective departments. The names, position, companies, and a list of topics they will be discussing are provided below. We hope everyone can attend.


**Dr. Marsha Hardiman, Senior Manager of Quality, Medtronic
  • With all the turmoil that is currently going on in the medical device industry, what is Medtronic doing proactively to stay as a leader of quality manufacturing?
  • What are some of the biggest hurdles that you have faced in quality?
  • Where do you see the medical device industry growing and what mechanisms do you feel must be put in place to ensure the highest standards of quality?
  • What are some career paths in quality that you see for students from KGI?
  • *Note: She also handles global manufacturing in Asia, Europe, and North and South America. She has a microbiology background, and has a strong background in pharmaceuticals then moved to medical devices, so she knows both of these areas well.
**Dr. Rick Lit, VP of Regulatory Affairs and Chemistry, Manufacturing and Controls (CMC), Amgen
  • When something is changed in the manufacturing process, how do you report that to the FDA and what processes do you have to go through?
  • In regards to the status of biosimilars, could you please discuss Amgen's draft guidances relating to the development of biosimilar products and how that has been received by the FDA.
  • Looking at Amgen's global expansion, how can current students get benefit from this opportunity and growth?
  • *Note: He's interested in post-approval manufacturing changes and he has written many articles in this area.
**Dr. Mickey Yraceburn, Associate Director of Manufacturing, Gilead Oceanside
  • What are the newest areas and advances in bioprocessing, and what innovations do you see coming to the field in the next few years?
  • What are your thoughts about the trend of outsourcing Contract Manufacturing Organization, and what this means for the field?
  • What challenges will manufacturing face in the near future, and how can we prepare?
  • *Note: He has experience in cell culturing and bioprocessing, so anyone interested in these areas, he is a great person to ask any questions.


If you are interested, please register for the event by following the eventbrite link. If you have any questions please contact Michael Choy, Director of Communications for the student chapter (mchoy14@students.kgi.edu)



Student PDA Chapter at KGI


Have questions about Quality, Regulatory, Operations Speaker Series (hosted by the PDA at KGI)? Contact the organizer

When & Where

517 Lecture Room, KGI
517 Watson Dr
Claremont, CA 91711

Friday, November 9, 2012 from 1:00 PM to 2:30 PM (PST)

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Quality, Regulatory, Operations Speaker Series (hosted by the PDA at KGI)
Claremont, CA Events Conference

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