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Alfredo Canhoto, Ph.D
Alfredo has been involved with the ASTM Standards creating process since its beginnings in 2007. Alfredo is a Director of Quality Assurance Operations at ITF Therapeutics, LLC and has over 20 years of industry and consulting experience specialized in biopharmaceutical validation, process and cleaning validation, development and program implementation, laboratory experimentation and instrumentation qualification, authoring articles and chapters and speaking on the same. |
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Parth Desai
Parth is Process Development Manager at Alkermes. Prior to Alkermes, Parth worked for Nostrum Laboratories for 13 years as Validation and OpEx Manager. While working at Stevens Pharmaceutical Research Center (SPRC), Parth managed three (3) studies on visual inspection, the development of Total Organic Carbon and conductivity analyses, and the application of Design of Experiments in cleaning process development for a cosmetic product. Parth's visual inspection studies were published in Pharmaceutical Online in 2017. Parth has over 13 years of experience in the pharmaceutical industry. Parth holds an MS in Pharmaceutical Manufacturing and Engineering from Stevens Institute of Technology. |
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Ovais Mohammad
Ovais has been involved with the ASTM Standards creating process since its beginnings in 2007. Ovais is a Subject matter expert on cleaning/process validation, quality assurance and quality risk management with more than 20 years of experience working in regulated pharmaceutical environments and has published several articles on cleaning validation issues. Ovias' technical expertise covers many areas of product/process development, validation and quality assurance including – life cycle management of product and processes, quality by design, quality risk management, quality planning, root cause analysis, formulating corrective and preventive actions, technology transfer, equipment qualification, validation of cleaning and manufacturing processes, and dossier preparation and review. Ovais has extensive experience in technical writing including authoring policies, master plans, protocols, company procedures and reports. |
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Portia Munhuweyi
Portia brings 16 years of diverse pharmaceutical industry experience spanning validation, regulatory affairs and pharmacovigilance across regional and international frameworks including SADC, EMA, WHO, FDA, and ICH. Her technical proficiency includes development of Health Based Exposure Limits (HBELs), Process and Cleaning Validation, Equipment Qualification and lifecycle management of validated systems, dossier preparation and regulatory submissions and pharmacovigilance systems. She has collaborated with multinational pharmaceutical companies and contributed to regional regulatory guidelines. Portia has worked on optimizing validation and compliance programs through strategic planning and cross-functional team leadership. Portia has also been involved with lean system development, operational excellence and capacity-building initiatives across Africa and beyond. |
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Osamu Shirokizawa
Osamu has been involved with the ASTM Standards creating process since its beginnings in 2007. Osamu is President and CEO of LifeScientia a consulting company in the Life Sciences in Japan. In addition to being a CPCI™ Board Member, Osamu is also on the Board of Directors of the Parenteral Drug Association (PDA) |
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Ruijin Song, MS
Ruijin is a Senior Validation Specialist at Beigene supporting cleaning validation at their new facility in Hopewell, New Jersey. Prior to her position at Beigene, Ruijin was a Senior Cleaning Process Development Specialist at CPCI™ for 7 years where she was engaged in extensive research on cleanability studies, including determination of "hardest-to-clean" products, cleaning agent selection studies, "time-to-clean" studies, and design of experiments to optimize cleaning processes for internal research and for CPCI™ clients. Ruijin also has extensive experience in TOC and UV-Vis method development and validation, swab recovery studies, and the qualification of Visual Inspection. Ruijin has an MS in Chemical Engineering from Columbia University and an MS in Material Science from Tongji University. |
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The Center for Pharmaceutical Cleaning Innovation is a Non-Profit Research Organization providing research and educational opportunities in Cleaning Process Development and Validation
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