Andreas Schreiner graduated from the University of Erlangen, Germany, in 1996 in Chemical Engineering. After a Ph.D. and a scholarship at the University College London, he joined Roche Vitamins as Head of Solids Processing. Since 2006 Andreas Schreiner 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 Schreiner is appointed board member at various scientific organisations (Executive Board of European Federation of Chemical Engineers (EFCE), Swiss Society for Process Engineers (SGVC), Industrial Society for Pharmaceutical Engineering (ISPE), Swiss Laboratory of Material Science and Technology (EMPA)). Since 2013 he works for the Manufacturing Science & Technology Department as Validation Head for Solid Dosage Forms. 

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.

Dr. Tim Sandle has over twenty-five years of experience in microbiological research and biopharmaceutical processing. Dr. Sandle is a member of several editorials boards, and he has written over six-hundred book chapters, peer-reviewed papers, and technical articles relating to microbiology. Dr. Sandle works for a pharmaceutical manufacturer in the UK and is a visiting tutor at both the University of Manchester and UCL. 

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.