Igor Gorsky has been a pharmaceutical, biopharmaceutical, and medical device industry professional for over 39 years. He held multiple positions with increasing responsibility at Alpharma, Wyeth, and Shire. He worked in production, quality assurance, technical services, and validation, including as an associate director of global pharmaceutical technology, at Shire, where he oversaw global validation efforts, including analytical methodology, equipment and facilities qualification, process, packaging, shipping, computer and cleaning validation, and environmental monitoring programs. He is currently a senior consultant at ValSource, LLC. Over the years, his accomplishments include validation of all the aspects of pharmaceutical, biotechnology, and medical device production and quality management, technical support of multi-billion-dollar drug product lines, and introduction of new products onto the market.

He developed analytical technology policies, procedures, and master plans for numerous biopharmaceutical firms based on latest global regulation. He also developed analytical technology qualification programs for many pharmaceutical and biopharmaceutical firms. He has published numerous articles and white papers in pharmaceutical professional magazines. He is an author of two books on pharmaceutical scale-up and process validation. In addition, he has been a presenter at PDA Annual Meetings, Interphex, UBM International Workshops, and other forums. He is also very active with PDA and ASTM participating in several task force groups authoring PDA technical reports 29 (Points to Consider for Cleaning Validation), 60 (Process Validation), and 60-2 (Process Validation Annex 1: OSD and SSD Dosage). He leads the PDA water interest group and is also a member of ASTM E55, G122).and participated in the ASTM E3106-18 Standard Guide for Science and Risk-based Approach to Cleaning Validation, and the ASTM E3219 and E3263. He holds a BS degree in mechanical/electrical engineering technology from Rochester Institute of Technology.

Morcos Loka is a training manager and GMP advisor at Minapharm. Over 23 years, Morcos has played different production and quality roles in the pharmaceutical and biopharmaceutical industries. His experience includes the manufacture of sterile and non-sterile products, handling of regulatory and customer audits, conducting internal and supplier audits, GMP gap analysis, GMP training, GMP consultation, establishing quality management systems, management review, quality metrics, establishing quality risk management system, QRM studies including manufacturing of HPAPIs in shared facilities, and design of pharmaceutical and biopharmaceutical manufacturing facilities.
Morcos has an MBA, a BSc with honours in pharmaceutical sciences, two postgraduate diplomas in total quality management (TQM) and train of trainer (ToT), and four professional certificates: ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE), Certified Quality Auditor (CQA), Certified Pharmaceutical GMP Professional (CPGP), and ISPE Certified Pharmaceutical Industry Professional (CPIP).

Morcos is an ASQ, ISPE, and PDA member. He participated in different ISPE and PDA publications and as a speaker in different IVT, ECA, PDA, and ISPE pharmaceutical industry conferences.

Walid El Azab is an industrial pharmacist, a qualified person, and a lean six sigma green belt. He is a technical services manager for STERIS Life Sciences. He provides technical support related to cleaning, disinfectants, sterility assurance, and process validation. Finally, he leads audits at manufacturer sites and workshops to improve processes and inspection readiness levels. Walid is a lecturer at a pharmacy and medicine university. He has published different articles and book chapters, and he is also part of working groups on sterilisation and EU GMP Annex 1 guideline revision. He is a planning committee member of the Annual PDA Conference on Pharmaceutical Microbiology (12th and 13th editions) and part of the editorial committee of the PDA Letter. Walid is an observer member of the ISPE Belgium affiliate board. Finally, he is the secretary of the Belgium Qualified Person Association.

Kevin Owen is an experienced aseptic fill-finish SME with over 30 years’ expertise within pharmaceutical operations and QC laboratory management. A microbiologist by training, Kevin specialises in ensuring aseptic fill-finish processes, QC laboratories, ‘specials’ facilities, and ATMP facilities are compliant to all regulatory requirements. He has managed product life cycle compliance from early-stage clinical trials to full commercial capability. He has experience of installing new lines and equipment within an existing facility whilst still retaining commercial capability. He is regulatory battle-hardened from his time as the client, with expert knowledge of cGMP and current/future compliance expectations, including Annex I. Kevin regularly lectures at international aseptic conferences. He is unique in supporting end-to-end projects from early-stage feasibility to final end-stage CQV practices and operator training. His operational expertise differentiates him. He is always patient centric. Kevin joined IPS in August 2022.

Yossi Shapira is a consultant expert in lyophilization and HPAPI processes containment and exposure solutions, as well as chemical laboratories design. He is the founder and owner of Containment Lyophilization Laboratories.

Yossi served 40 years at TEVA Pharm. Ind., where he gained substantial experience in parenterals production, freeze drying processes, HPAPI handling, and most recently he spent six years in the global engineering department on special projects and technologies.

Overall, Yossi supported investigation development and optimization scaling up of lyophilization methods and safety managing for binary organic solvents solutions, drug substances, and drug products. The lyophilization process requires laboratory studies on critical parameters. Accordingly, Yossi designed and adapted the lyophilization process, trained and taught OJT, and scaled up the tested freeze-drying processes. It was also his responsibility to review new freeze-drying processes design, and he submitted processes to regulatory bodies prior to product file submitting.

Yossi is a member of the International Society for Lyophilization Freeze Drying ISL-FD and has been a guest speaker, lecturer, trainer and chairperson at several international conferences over the years.

Ryan Murray is a quality and manufacturing science Senior Consultant with ValSource, Inc. He is primarily focused in the areas of quality and regulatory compliance, facility design and control, technology transfer, process qualification, and aseptic risk management of both biologics and advanced therapy medicinal products (ATMPs). Ryan is an active member of the Parenteral Drug Association’s Texas Chapter and the International Society for Pharmaceutical Engineering (ISPE). He has a BS in biomedical science and MS in biochemistry and biophysics from Texas A&M University.

Matthias Mikkelsen is a fill-finish machinery expert and has been working with technology companies for more than 25 years, with more than 10 years' experience in the pharmaceutical and medical industries. As part of the Watson-Marlow Flexicon team, Matthias guided well-known biopharmaceutical companies in the design and construction of aseptic fill/finish systems, specifically for RTU small-batch production. He has supported projects from the early stages of containment selection and integration, the user requirement specification (URS) creation, over functional design specification, design qualification, and the final factory acceptance test. Constant technical training and specialist GMP seminars have enabled him to find the best fit solutions for companies looking for fill/finish machines for GMP compliant production. Today he is the EMEA Flexicon System specialist, responsible for the fully automatic product line.

Oliver Stauffer received his Bachelors of Science degree from the University of Michigan and completed his MBA at Georgetown University. He began his career in analytical and R & D laboratories, with a focus on sensory technologies, physio-chemical measurement and test method development specific to package testing. Stauffer joined PTI in 2005 as a member of the research and development team working on non-destructive testing of high-risk pharmaceutical packaging. In 2006, he joined the sales team as applications engineer for PTI Inspection Systems. He held the position of International Business Development Manager for PTI through 2010, followed by COO through 2015, focusing on global quality solutions for package inspection that provide the highest level of measurement accuracy and reliability.   During his time with PTI he has developed several technology platforms, measurement methodologies, and technology patents.  In 2016, he was appointed as CEO.