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Sudhakar Nagaraj
Principal Scientist: SLS – Global Regulatory and Validation Consulting Group - Pall Biotech
Professional Bio
Sudhakar Nagaraj has been in Biopharmaceutical industry for over 21 years and has held positions of increasing responsibility in Pharmaceutical QA/QC, Validations and Regulatory support. He joined Pall during 2006 in Scientific Laboratory Services (SLS) organization as a technical leader in microbial contamination control and has extensive experience with sterile and virus filtration applications. He has also been involved in updating Pall’s technical support
portfolios with rapidly evolving end-user and regulatory requirements, to streamline customer selection, adoption and successful regulatory approval of Pall technologies.
Currently, he is part of SLS Global Regulatory and Validation consulting team, which is focused to provide streamlined technical guidance, scalable, customer-focused solutions to facilitate customer specification, qualification, validation and regulatory approval with Pall technologies. Examples of customer-focused solutions include application of risk assessments for adoption of Pall technologies, development of improved Extractables and Leachables validation service, high risk fluids filter validation service (SOAR), customer-aligned change management model, online access to controlled filter integrity test values, standardized material compatibility information, Biotech material resins repository, BPOG & USP extractables datasets and QbD/QRM support packages.
He is an active member of PDA & ISPE, representing Pall in Asia. He has completed postgraduation in Microbiology and based at Bangalore, India.
portfolios with rapidly evolving end-user and regulatory requirements, to streamline customer selection, adoption and successful regulatory approval of Pall technologies.
Currently, he is part of SLS Global Regulatory and Validation consulting team, which is focused to provide streamlined technical guidance, scalable, customer-focused solutions to facilitate customer specification, qualification, validation and regulatory approval with Pall technologies. Examples of customer-focused solutions include application of risk assessments for adoption of Pall technologies, development of improved Extractables and Leachables validation service, high risk fluids filter validation service (SOAR), customer-aligned change management model, online access to controlled filter integrity test values, standardized material compatibility information, Biotech material resins repository, BPOG & USP extractables datasets and QbD/QRM support packages.
He is an active member of PDA & ISPE, representing Pall in Asia. He has completed postgraduation in Microbiology and based at Bangalore, India.