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 level. 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 secretary of the Belgium Qualified Person Association.

Jernej has a Master's degree in pharmaceutics. He has been in Novartis for eight years in MS&T (Manufacturing science and technology) department and has expertise in Product Validation, Packaging Validation, and Cleaning Validation.

Fred Ohsiek is the Sr Cleaning Validation Specialist for Novo Nordisk in Clayton, NC. He earned his Bachelor in Chemistry from the 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 20 years of cleaning validation while working for Catalent Pharma Solutions, Amylin Pharmaceuticals, Ben Venue Laboratories, Teva Pharmaceutical Industries, Astellas Pharma Technologies Bayer (biotech division), and Novo Nordisk. He was considered a subject matter expert in cleaning validation in most positions held.

His cleaning validation experience includes developing, validating, and monitoring cleaning processes for equipment used to manufacture small molecule [oral dose (solid and liquid) and parenteral], peptide hormone encased (parenteral), and large molecule (biotech) pharmaceutical, OTC, and nutritional products. The scope of his work involved API and finish product manufacturing start-up, remediation, legacy process justification, and increasing manufacturing capability. He has authored documents and executed in every aspect of the cleaning validation process.

He has conducted risk assessments for initiation of cleaning validation program/scope, determining cleaning monitoring frequency, and dated cleaning validation packages.

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

20+ years of expertise as a toxicologist specialized in risk assessment of pharmaceutical excipients, impurities, and leachables from materials of construction used in medical devices and drug/device combination products. Member of the International Standardisation Organisation Technical Committee 194 working group for several biocompatibility standards of medical devices (ISO 10993 series). Assessment of pharmaceutical excipients, impurities, and leachables from materials of construction used in delivery devices and manufacturing of drug products. Driver of innovation in strategies and development of state-of-art practices for health risk assessment of polymer materials.

Mr. Vashi is a proven leader & a change agent with over sixteen (16) years of experience in validation, risk management, product transfer & technical project management for the pharmaceutical (injectable, OTC & solid dosage) and medical device industries. He is a value-focused professional with experience in implementing streamlined processes/procedures to facilitate robust Quality Management Systems ensuring operational efficiency, user/patient safety while meeting regulatory requirements.

Senior Director, Science & Marketing 20+ yrs pharmaceutical, cGMP, analysis, cleaning, process, and cleaning validation, sterility, and risk assessment. Jeff worked with companies such as Wyeth, Pfizer, Roche, Watson, Stryker, and many others.

Riffard Jean-Gilles is the Senior Director of Field Applications Science at Unchained Labs. He has served in various leadership and technical roles at Unchained Labs. Prior to Unchained Labs, he worked as an applications scientist at Malvern Instruments, earning several company awards. He worked in R&D at GE’s Global Research center, publishing several patents and publications on optical materials development and worked on multiplex antibody platform developments. Additionally, he’s published and holds patents in protein functionalization and biomaterials development for artificial tissue engineering. He holds graduate degrees in Chemistry and biotechnology management from Villanova University and Harvard University.