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.

Andrew Walsh is president of the Center for Pharmaceutical Cleaning Innovation (CPCI™), a not-for-profit research and educational organisation and laboratory whose purpose is to support pharmaceutical, biologics, cosmetic, and medical device companies in the implementation of the science, risk, and statistics-based approaches of the ASTM E3106 "Standard Guide on Science-Based and Risk-Based Cleaning Process Development and Validation". CPCI supports companies through its research into developing new technologies (two patents), its educational offerings (courses, workshops, and publications), and internship opportunities for students. 

Prior to joining the pharmaceutical industry, Andrew worked for 10 years at the Colgate-Palmolive and Clorox companies as an analytical chemist and microbiologist. Andrew then worked in the field of validation for over 30 years for major pharmaceutical companies; Johnson & Johnson (RWJ Pharmaceutical Research Institute, Ortho-McNeil, and Ortho-Biotech), Schering-Plough, and Hoffmann-La Roche.  

After leaving Hoffmann-La Roche in 2007,  Andy founded Clean6Sigma, LLC, to provide consulting services in cleaning process development, and cleaning validation to pharmaceutical, biotech, and medical device companies using lean and six sigma techniques. 

In 2008, Andrew became a full-time professor at Stevens Institute of Technology in their pharmaceutical manufacturing and engineering program, where he developed and taught validation and lean six sigma in pharmaceutical manufacturing courses until 2015. In 2019, Andrew joined the Temple University school of pharmacy regulatory affairs and quality assurance program to teach a graduate level course in cleaning validation. Andrew recently published a textbook,  "Cleaning Validation:  Science, Risk and Statistics-based Approaches", for use in his classes.  

Andrew is very active in developing industry consensus standards with the American Society for Standard and Materials (ASTM International) and has led the teams writing the E3106 "Standard Guide on Science-Based and Risk-Based Cleaning Process Development and Validation", the E3219 "Standard Guide for Derivation of Health-Based Exposure Limits (HBELs)", the G121 "Standard Practice for Preparation of Contaminated Test Coupons for the Evaluation of Cleaning Agents", the G122 "Standard Test Method for Evaluating the Effectiveness of Cleaning Agents and Processes", and the E3263 "Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues". Andrew was also a co-author of the ISPE "Risk-based Manufacture of Pharmaceutical Products Guide" (Risk-MaPP) and is on the team updating the PDA Technical Report No. 29 on cleaning validation. 

Andrew has a master’s in biology (microbiology) and is a certified lean six sigma black belt and an accredited trainer. Andrew can be contacted at [email protected]. 

Ester Lovsin Barle, DVM, MSc, PhD, MScTox is the global head of product sustainability and stewardship and at Takeda Pharmaceuticals. She lives in Zurich, Switzerland.

Ester is passionate about generating value with product safety and sustainability. She is leading the cross-organizational product sustainability workstream sustainability by design for the planet pillar of purpose-led sustainability in Takeda. Her responsibilities also include product stewardship topics, such as safety data sheet process, maintaining article and material regulatory compliance and scientific development and cross-organisational implementation of health-based exposure limits (HBEL) in support of research and manufacturing in Takeda globally. Previously she has held corporate positions at Lonza and Novartis. She has been working in the pharmaceutical industry for over 15 years. She received her PhD in veterinary sciences from University of Ljubljana, Slovenia, and a second master’s degree in toxicology and risk assessment from Medical University in Vienna. Ester is a certified toxicologist.

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.

Thomas Altmann has 22 years’ experience in cleaning chemistry, cleaning process, cleaning validation, and regulatory compliance. As technical consultant and validation manager, he provides technical consultation on cleaning and sanitisation process optimisation for pharmaceutical, API, biotechnology, and personal care manufacturers in Europe, Middle East, Asia Pacific, North America, and Africa. In his role, Thomas is a subject matter expert in cleaning validation for product contact surfaces across all types of pharmaceutical and personal care production equipment.

Andreas Schreiner graduated from the University of Erlangen, Germany, in 1996 in chemical engineering. After a PhD and a scholarship at the University College London, he joined Roche Vitamins as head of solids processing. Since 2006, Andreas has worked for Novartis in various departments with increasing responsibilities from project leader to global technology platform leader; currently, he is heading the validation activities for pharmaceutical production of solid dosage forms. Andreas is an appointed board member at various scientific organisations, including the Executive Board of European Federation of Chemical Engineers (EFCE), Swiss Society for Process Engineers (SGVC), Industrial Society for Pharmaceutical Engineering (ISPE), and Swiss Laboratory of Material Science and Technology (EMPA). Since 2013, he has worked for the manufacturing science and technology department as validation head for solid dosage forms.

Sunil has over 17 years of experience working in the engineering and validation fields of cGMP / FDA / EU / ISO regulated industry sectors.  

Sunil has a strong background in Cleaning Validation (CIP, COP, Manual), Process Validation, Process Design, Clean Utilities (WFI, PW, Clean Steam, Clean Air, Clean Gases), HVAC, Project Management, Sterilization and Processing Equipment Validation. Further expertise includes Process Optimization/Improvement, Regulatory Compliance and Risk Management methodologies for the pharmaceutical and biologics industry.  

Prior to joining Valgenesis, Sunil has had variety of Validation roles as consultant and corporate employee with increased responsibilities within Pharmaceutical and Biologics industry including Catalent, Eisai, Pfizer, Teva and Novartis.  

Fred Ohsiek is the senior global technical manager, life science (cleaning validation) for Ecolab in North America. His focus at Ecolab is to assist customers with cleaning validation/cleaning challenges and cleaning process optimisation.

He earned his bachelor’s in chemistry from University of South Florida. His professional work experience includes seven years of R&D performing enzymatic digestion, ultrafiltration and fermentation on citrus peel while working for the USDA and over 22 years of cleaning validation while working for Catalent Pharma Solutions, Amylin Pharmaceuticals, Boehringer Ingelheim, Teva Pharmaceutical Industries, Astellas Pharma Technologies Bayer (biotech division), and Novo Nordisk.

His cleaning validation experience includes risk assessments, cleaning development, validation, and monitoring of cleaning processes for equipment used in small molecule (oral dose - solid and liquid - and parenteral), peptide hormone encased (parenteral), and large molecule (biotech) pharmaceutical, OTC, and nutritional product manufacturing.

The scope of his work involved drug substance and drug product manufacturing startup; remediation and legacy justification; creating/improving routine monitoring programs; and increasing manufacturing capability. He has also introduced and incorporated methods to lean the CV footprint by reducing documentation and execution.

He was one of the authors on the new ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls and the cleaning validation acceptance criteria chapter lead.

Sophie is a senior cleaning process development scientist at the Center for Pharmaceutical Cleaning Innovation (CPCI™), where she has been doing research on cleanability studies for pharmaceuticals, biologics, and medical devices and developing mathematical models of cleaning processes. Ruijin is also engaged in the development and design of an automated high throughput cleanability testing device, the automation of a model CIP system, and using the design of experiments to optimise cleaning processes of pharmaceutical products. Ruijin has presented at two industry conferences on cleaning process development and published three research articles last year on selecting "Hardest-to-Clean" products based on cleanability, the selection of cleaning agents, and "Time-to-Clean" studies and the cleaning assurance level (CAL). Sophie has a master’s degree in chemical engineering from Columbia University.