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Introduction by Merck KGaA
Regulatory Considerations for Single-Use Manufacturing
Jessica Shea
  • Jessica Shea (Emprove® Program Manager at MilliporeSigma)

    Jessica Shea

    Emprove® Program Manager at MilliporeSigma

    Jessica Shea is the Emprove® Program Manager responsible for Filters, Single-Use and Chromatography resin portfolios within our company. Previously, she was responsible for Extractables and Leachables Global Support for the BioReliance® Validation Services. She has more than 15 years of E&L experience, including method validation, designing of custom testing, and interpreting industry and regulatory guidance. Jessica has a Bachelor of Science in Biochemistry and a Master of Business Administration.

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Break
Patient Safety Evaluation: Risk Assessment and Evaluation of Analytical Evaluation Threshold for Single-Use Manufacturing
Ramesh Raju
  • Ramesh Raju (Head of Operations, Validation Services Lab at Merck KGaA)

    Ramesh Raju

    Head of Operations, Validation Services Lab at Merck KGaA

    Ramesh Raju is the Head of Operations, Validation Services Lab at Bangalore which provides aseptic filter validation services to Asia & Oceana, Middle East and Africa, LATAM, Mexico and TRUE along with the Indian subcontinent. Previously he was managing the Technology management team in India. He has 25 years of experience in aseptic processing and validation of injectables. He is currently pursuing his Doctorate program in extractable and leachable from Kuvempu University.

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Lunch & Network
Pre-briefing for workshop
Ramesh RajuJessica Shea
  • Ramesh Raju (Head of Operations, Validation Services Lab at Merck KGaA)

    Ramesh Raju

    Head of Operations, Validation Services Lab at Merck KGaA

    Ramesh Raju is the Head of Operations, Validation Services Lab at Bangalore which provides aseptic filter validation services to Asia & Oceana, Middle East and Africa, LATAM, Mexico and TRUE along with the Indian subcontinent. Previously he was managing the Technology management team in India. He has 25 years of experience in aseptic processing and validation of injectables. He is currently pursuing his Doctorate program in extractable and leachable from Kuvempu University.

    More information about speaker
  • Jessica Shea (Emprove® Program Manager at MilliporeSigma)

    Jessica Shea

    Emprove® Program Manager at MilliporeSigma

    Jessica Shea is the Emprove® Program Manager responsible for Filters, Single-Use and Chromatography resin portfolios within our company. Previously, she was responsible for Extractables and Leachables Global Support for the BioReliance® Validation Services. She has more than 15 years of E&L experience, including method validation, designing of custom testing, and interpreting industry and regulatory guidance. Jessica has a Bachelor of Science in Biochemistry and a Master of Business Administration.

    More information about speaker
Knowledge sharing exercise (4 case studies)
Wrap up and Close
Transport to Facility
Facility visitsMerck M Lab™ and Korea NIBRT

The facility visits will be at the following:

M LAB™ COLLABORATION CENTERS allow you to engage with experts, explore novel modalities, and advanced techniques, to help bring therapeutics to more patients, more efficiently, with more confidence.
Location: 24th fl., Bldg. M,Songdo Techno Park IT Center 32, Songdogwahak-ro, Yeonsu-gu, Incheon, 21984

K-NIBRT is the Korean branch of Ireland National Institute for Bioprocessing Research and Training.
Location: 21983 Freedom Hall B, 85, Songdo Gwahak-ro, Yeonsu-gu, Incheon (Postal) 21983

For more information please click on the 'Facility Visits' tab on the site menu.