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.

Alberto is a pharmacist with 15 years of multinational experience in the pharma and biotech industries.

In his first roles he was responsible for Quality Assurance, Quality Systems and Quality Compliance for sterile products.

In his current position with Takeda’s Global Sterility Assurance and Microbiology team he has had a pivotal role on the company-wide implementation of Annex 1. His expertise lies with Aseptic Process Simulations, Contamination Control Strategies and application of Quality Risk Management to aseptic production. This can be summarized in his motto: “Think Aseptic”.

He is an invited speaker at industry conferences and is active in industry collaborations.