Christa Myers has been in the pharmaceutical industry for over 25 years and is a leader and subject matter expert. Christa is a well-recognized speaker at conferences and is frequently on-stage teaching others about regulatory requirements, operational issues and what to expect in the future of the in­dustry. Christa champions approaches that integrate strong project execution and technical solutions. Christa is on the steering committee for the ISPE community of practice for sterile products processing, a certified ISPE instructor of the sterile product processing baseline guide, the chair of ISPE’s women in pharma group, as well as an author of the most recent ISPE sterile processing baseline guide. Christa provides guidance and leadership to clients on how and when to utilise common or innovative solutions and continuously promotes the technical growth of people willing to learn more to advance the industry. She was recently awarded an honour as one of the 2019 Influential Women in Manufacturing.

James L. Drinkwater is the ex-chairman and an honorary member of the Pharmaceutical and Healthcare Sciences Society (PHSS), a not-for-profit educational platform for GxP and current leader of PHSS special interest groups on aseptic processing and biocontamination. He's the PHSS co-lead of Annex 1 revision (sterile medicinal product manufacturing) focus group and contamination control strategy (CCS) guidance initiative. James is also the current head of GMP compliance at Franz Ziel GmbH and actively involved in pharmaceutical, biologics, and ATMP product manufacturing as well as fill and finish projects. Based in the UK, James has a global support role and is also a qualified trainer on aseptic processing.

Richard Denk has studied mechanical engineering and did an examination on experts of GMP, qualification and validation, pharmaceutical auditing, phar­maceutical engineering, and quality control at the University of Applied Sciences in Albstadt/Sigmaringen, Germany. Richard works at SKAN AG, headquartered in Allschwil, as the head of sales containment. He founded the expert con­tainment group of the ISPE DACH eight years ago. The containment group published the containment manual in September 2015. Richard has spent nearly 20 years working with highly active/highly hazardous substances and has developed the containment pyramid.

David Dunne is a highly experienced Equipment, Cleaning, and Process Validation Lead with over 28 years of experience in the pharmaceutical and biotechnology industry. He has been extensively involved in start-up projects for biologics, vaccines, and sterile manufacturing across multiple multinational organizations. His professional background spans chemical, pharmaceutical, biopharma, and animal health sectors. David Dunne brings 14 years of people management and leadership experience. He has held diverse roles across design, engineering, technical operations, validation, and quality functions.

Biologist with a Master’s Degree in Pharmaceutical Industry and a Master’s Degree in Business Administration, with over 20 years of experience in the pharmaceutical and life sciences industry.

Recognized expert in Quality Assurance, Digital Transformation, Data Integrity, and GXP Compliance, with a strong background in sterile manufacturing, automation and innovative pharmaceutical quality management. Lead compliance projects and strategic transformations, ensuring alignment with ICH Q10, GMP, GAMP5, CSA, Annex 11 and Data Integrity.

Vice-president in the Spanish Association of Industry Pharmacists, active participant in ISPE and PDA, speaker in international conferences, and associate professor in Pharma Business Schools.

Dr Anne Orillo started her carrier in Pharma as a Post-Doc researcher in immunology at Otago University, New Zealand following her Pharmacy qualification and PhD at the Free University, Berlin.  From 2006, experiences across Technical R&D in Biologics formulation development followed by Technical Operations Supply Chain Management preceded later roles in Steriles production.  Since 2022, Anne has focused on the process transfer of Sterile products as Site Validation Lead at Novartis Stein. More recently she is directly involved in Health Authority audit site representation and Regulatory Filings. 

Terri Love is a Senior Biomanufacturing Engineer within the Manufacturing and Sciences Technology team at Merck KGaA, based in Ireland. With a BSc in Industrial Biochemistry from the University of Limerick, she began her career at Lonza Biologics in the UK before returning to Ireland to join Merck.

With over 23 years in the biopharma industry, Terri has spent nearly 20 years as a field-based Biomanufacturing Engineer at Merck KGaA. Her role involves collaborating with Irish biopharma customers on technology transfers, scale-up processes, and implementation strategies. Notably, she has worked on final fill tech transfers, specifically with single-use assemblies, and refining PUPSIT procedures. Additionally, Terri has experience with troubleshooting design issues related to filter assemblies, leaks, and integrity testing, ensuring compliance with aseptic processing standards.

Dr. Stefan Schneid is currently the Scientific Lead Parenterals in CMC Drug Product and Science Fellow at Bayer AG. He is responsible for scientific and strategic advancement of formulation and process development for novel biological entities, small molecules and new modalities. He is involved in parenteral development and marketed projects from the preclinical stage up to transfer to commercial production. Previously, Stefan worked as a Laboratory Head in Bayer’s parenteral formulation development group. Prior to joining Bayer, he was a R&D manager at Syntacoll, where he was responsible for developing novel formulations for drug-containing biodegradable implants. Stefan spent one year as a visiting scientist in Prof. Michael Pikal’s lab at the University of Connecticut. He holds a degree in pharmacy from the University of Munich and a Ph.D. in pharmaceutics from the University of Erlangen.

Srdjan is a pharma professional specializing in contamination control and aseptic facility design. With a Master’s degree in Mechatronics, Robotics, and Automation Engineering, he brings extensive expertise in cleanroom qualification, HVAC systems, and GMP compliance for large-scale CAPEX projects. At Lonza, Srdjan oversees front-end quality for global investments, ensuring regulatory compliance and lean operations. He has extensive experience in cleanroom performance qualification in line with ISO14644 standards and is committed to advancing contamination control practices within the pharmaceutical industry.

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.

Dr. Birte Scharf has eleven years of pharmaceutical background and six years working experience in aseptic processing technologies; Birte combined her passion for science and technology through working for Franz Ziel GmbH, a manufacturer of isolator technology and GMP compliance service provider. As a Senior scientist in GMP Compliance Team she focusses on GMP compliant process integration and on science and compliance of R&D projects at Franz Ziel. Birte received her PhD in pharmaceutical Biology working on treatments against uropathogenic E.coli at the University of Muenster.