CEU Morning Education Event: 8:30 am – 12:00 pm

• This is an opportunity to earn up to 4.0 professional development hours on the morning of the ISPE DVC Symposium & Exhibition
• Registration starts at 8:00am
• Breakfast and Lunch will be served
  • Breakfast 8:00am to 9:00am
  • Lunch 10:45am to 12:00pm
• Location: South Lounge Suites

Educational Topics

8:30am – 9:30am: ISPE’s New Critical Utilities GPG – Sustainability

• Critical utilities within pharma manufacturing environments are traditionally expensive to own and to operate with a significant environmental impact. This new Good Practice Guide, prepared by the Critical Utilities COP, is slated for publication in mid-2026 and targets improved sustainability across critical system life-cycles; including design and operation, of water, steam and process gas systems. This guide’s focus supplements the recently published Sustainability Guide prepared by the newly established Sustainability COP. This guide discusses various technology options to improve carbon footprint, GHG reduction, energy savings and overall improved environmental responsibility.

Joseph Manfredi

President & CEO, GMP Systems, Inc.

Internationally recognized for his expertise in pharmaceutical processing, Mr. Manfredi has spent more than 45 years designing systems, overseeing fabrication and installation, trouble shooting, training and providing consulting services for most of the world’s major health science manufacturers.

A graduate of the Newark College of Engineering (NCE) at NJ Institute of Technology, Mr. Manfredi was instrumental in establishing the Pharmaceutical Engineering Masters of Science Program there and taught many of the “core” courses while serving as Chair of the Pharmaceutical Engineering Advisory Committee.

A member of many professional and industrial associations including PDA, ISPE, AWS, ASME and NJBIA, he is often asked to lecture, train welders and lead courses both domestically and internationally.

9:30am – 9:45am: BREAK

9:45am – 10:45am: Advancing Decon: Use and Validation of 7% Vapor Phase Hydrogen Peroxide in Isolated Fill-Finish Systems

• This case study explores the development and use of novel rapid low-concentration vapor phase hydrogen peroxide (VPHP) in an isolated fill-finish manufacturing setting. Effective decontamination protocols using hydrogen peroxide are common in sterility strategies but impose significant operational constraints, including HAZMAT requirements and hours of operational downtime, due to factors such as method of application, solution potency, and volume applied during decontamination. Conventional methods using high-concentration hydrogen peroxide vapor—with risks to staff and sensitive equipment, and significant off-gassing—have been considered unavoidable. Recent advancements in decontamination technology, however, have focused on process, efficiency, and safety improvements that are both regulatorily robust and consider manufacturing realities around new products like highly targeted, time-sensitive liquid pharmaceuticals.
• In this presentation, validation data will be used to assess the effectiveness of low-concentration, low-volume VPHP in achieving >6-log reduction, reducing outgassing (PPM over time), expanding material compatibility, and decreasing manufacturing downtime. Educational objectives include:

• • Assessing needs and opportunities for advancement within the pharmaceutical manufacturing industry.
  • Analyzing new multi-application research on the use of low-concentration VPHP to achieve 6-log reduction.
  • Reviewing validation approaches and considerations for implementing low-concentration VPHP in a fill-finish manufacturing setting.

Josh Russell

VP of Technical Sales, AST

Josh Russell has been leading the design and implementation of new, innovative technologies within the life sciences for over 20 years. In that time, he’s worked towards developing solutions that support breakthroughs in patient-centered medicine, including spearheading the design and development of adaptive robotic systems for aseptic processing that are now widely used throughout the industry.

After earning his bachelor’s degree in mechanical engineering from St. Martin’s University, Josh designed complex industrial machinery and systems early in his career for a variety of industries, including aerospace, hygiene, and life sciences. He quickly grew a passion for developing solutions that address the emerging challenges brought on by the biopharma industry’s shift toward more personalized patient-specific therapies.

With AST, Josh advocates for intelligent, intuitive, and innovative solutions for safe, effective drug product manufacturing.

Jason Rossi

Principal Commissioning, Qualification, and Validation Engineer, AST

Jason Rossi has over 30 years of operational expertise and leadership in various capacities throughout the pharmaceutical manufacturing industry. His experience includes project management, GMP facility and equipment design and installation, technology transfer, targeted drug manufacturing, and onsite CQV program development. Jason has been at the forefront of drug development, playing pivotal roles in bringing innovative new products to market, including first-generation gene-based hemophilia therapeutics.

At AST, Jason leads team efforts to ensure that AST’s products, systems, and processes meet the highest standards of quality and compliance, and spearheads on-site CGMP strategies in line with the latest regulations, technological advancements, and best practices for documentation, quality risk management, and validation.

Prior to AST, Jason held operational and leadership roles at leading pharmaceutical companies, including serving as Fill-Finish Manager at Pfizer, Head of Microbial Contamination Control at Lonza, and, most recently, Global Assistant Director of Engineering at Catalent, where he led cell and gene therapy development initiatives.

10:45am – 11:00am: BREAK & LUNCH SERVED

11:00am – 12:00am: Review of new ISPE Good Practice Guide Standardized Methodology for the Evaluation of Pharmaceutical Airborne Particle Emissions from Containment Systems

• This presentation provides an overview of the newly revised ISPE Good Practice Guide SMEPAC 3rd edition, which offers a standardized approach to evaluating airborne particle emissions from containment systems used in pharmaceutical manufacturing. The session will focus on the guide’s key updates, including enhanced testing methodologies, improved evaluation criteria, and alignment with pharmaceutical company and containment equipment vendor requirements. Abstract: The revised ISPE Good Practice Guide: Standardized Methodology for the Evaluation of Pharmaceutical Airborne Particle Emissions from Containment Systems introduces enhanced guide for assessing airborne particle emissions in pharmaceutical containment systems. Since the publishing of the second edition of this Guide, pharmaceutical industry professionals have performed numerous CPAs following the criteria outlined in the Guide. These CPAs have provided significant data and lessons learned for the various equipment tested. The introduction of more complex equipment systems, additional information regarding the selection of surrogates, and experience with data interpretation necessitated the writing of a third edition.

George S. Petroka

CIH, CSP, LWSMS, Principal IES

Mr. Petroka has over 40 years of experience in environmental, health and safety (EHS), industrial hygiene, and process safety within the process industries. His career includes key roles at Sanofi, Sterling Winthrop, Sunoco, and Pennsylvania Manufacturers Insurance Company (PMA). He has extensive expertise in the pharmaceutical sector, having managed EHS programs at Sanofi and Sterling Winthrop. As a Principal at IES, George is responsible for BioPharma business development, as well as the execution and management of BioPharma and EHS services. He has conducted numerous potent compound assessments, industrial hygiene surveys, process improvement evaluations, and containment performance assessments for pharmaceutical and biotechnology clients. George is an active member of the ISPE Containment Community of Practice (CCOP) and led the development of the ISPE Good Practice Guide Containment Guide. He also recently co chaired the third revision of the ISPE Good Practice Guide SMEPAC. Mr. Petroka holds an M.S. in Environmental Science and Engineering from Drexel University, as well as a B.S. in Safety Management and a B.A. in Biology from Indiana University of Pennsylvania. He is a Certified Industrial Hygienist (CIH), a Certified Safety Professional (CSP), and a Legionella Water Safety Management Specialist.

Morning Education Cost: $80 per ISPE Member; $110 per Non-Member; $45 for ISPE Emerging Leader/Student until July 30^th. After July 30^th, each ticket increases by $30 for late registration pricing.