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2022 Volunteer Spotlight: Publishing, Guidance Documents, Technical Communities, & Regulatory

ISPE
2022 Volunteer Spotlight: Publishing, Guidance Documents, Technical Communities, & Regulatory

Meet ISPE volunteers participating in Publishing, Guidance Documents, Technical Communities, & Regulatory.

Dr. Ferdinando Aspesi has been a member of ISPE since 1992 and has volunteered as Chair of the Pharmaceutical Engineering Committee (PEC) for more than 4 years. During that time, Ferdinando has managed the committee work including leading topical and sourcing discussions at meetings to help identify topics of interest for Pharmaceutical Engineering magazine. He has helped source many excellent articles and authors and is a wonderful resource to the editorial staff on subject matter areas. Ferdinando is a great partner to ISPE staff in providing quality content to ISPE members and the industry in Pharmaceutical Engineering magazine.


Erich has been a member of ISPE since 2005. He is the chair of the new ATMP Community of Practice Steering Committee. He has also written articles for Pharmaceutical Engineering magazine, reviewed Workforce of the Future training materials, contributed to the development of the ISPE Baseline Guide - Biopharmaceutical Manufacturing Facilities Task Team, and led the kick-off of two new Communities of Practice. Erich is an experienced Bioprocess SME and internationally recognized authority in the domains of cell therapy, gene therapy, and bioprocessing. He is a published author of over 30 technical papers and a conference presenter on process technologies and operations. Currently, he is the Lead Process Engineer at Regenerative Medicine.


Christine has been a member of ISPE since 2012. She has chaired the Product Quality Lifecycle Implementation (PQLI)® committee since 2018. The PQLI committee develops solutions in emerging regulatory and scientific topics related to CMC and GMP approaches to ensuring product quality. These solutions are delivered via ISPE publications and education. Christine is also a member of the Regulatory Steering Council (RSC) and the Regulatory Quality Harmonization Committee (RQHC). She has been a frequent speaker at ISPE conferences, served on the program committees for several conferences and workshops, and on the ISPE International Board for 2 years. She is currently the Executive Director, External Advocacy & Policy at Organon.


Heather D. Watson has been a member of ISPE since 2001. During that time, she has been an active member of GAMP, serving as chair of the Global GAMP Global Steering Committee, core task team leader of the upcoming second edition of the ISPE GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems, and co-chair of the ISPE GAMP® Good Practice Guide: Enabling Innovation – Critical Thinking, Agile, IT Service Management. Heather has more than 30 years of working in the pharmaceutical industry. Currently, she is a Company Director and Consultant at TenTenTen Consulting Limited. Before this, she was Director, Computer System Quality Assurance, part of the Global Quality Assurance organisation, at GlaxoSmithKline (GSK) R&D based in the UK.


Chip Bennett, PMP, has been a member of ISPE since 2003. He was co-chair of the second edition of the ISPE Good Practice Guide: Good Engineering Practice and is a member of numerous CoPs. Chip is a consultant and a PMI® Certified Project Management Professional (PMP) with over 20 years of experience as a consultant, validation engineer, and project manager in the pharmaceutical and regulated non-pharmaceutical industries. Chip is the CAI lead subject matter expert for Quality Risk Management and commissioning, qualification, and validation program development, and is a subject matter expert in aseptic manufacturing, cleaning validation, quality systems, and owner project management.


Brian Pochini, CPIP, has been a member of ISPE since 2004. He has helped with numerous ISPE Guides, currently as co-chair of the ISPE Good Practice Guide: Membrane-Based Water for Injection Systems and the third edition of the ISPE Baseline Guide: Biopharmaceutical Manufacturing Facilities. In addition to serving as a co-chair of the newest edition of the ISPE Baseline Guide: Water and Steam Systems, Brian was a member of the ISPE Guide: Advanced Therapy Medicinal Products – Autologous Cell Therapy. He is secretary of the Knowledge Network Council. Brian is a Principal Engineer working in Sanofi Specialty Care Operations Engineering. He has 17 years of practical experience in biotechnology, membrane manufacturing/development, and custom chemical industries.