Susan B. Cleary, B.Cs, EMBA, is the Director of Product Development at Novatek International. 

Susan has more than 20 years of experience in designing, developing, and implementing large scale quality management and contamination control systems. 
 
Susan works with pharmaceutical, biotech, and medical device companies and specializes in data integrity and regulatory compliance and is highly experienced with streamlining quality processes and digitizing data for GMP systems.

Eur Ing Bob Hayes BSc, CEng, FIMechE, FIET

Bob worked in the Pharmaceutical Industry for over forty years. His experience includes Production and Engineering Management, New Product Development, Factory Design, Supply Chain Management, Validation and a variety of support functions.  He has a special interest in the use of risk management and modern quality methodologies in the various aspects of regulatory compliance.

Since 2003, Bob has been the Vice-Chair, Pharmaceuticals Committee, Institution of Mechanical Engineers (IMechE).  He is a Fellow of the IMechE and of the IET (Institution of Engineering and Technology).

As well as his experience in the Pharmaceutical industry, Bob has also worked in a range of other industries, including: aerospace, precision engineering, FMCG, insurance and e-commerce.

Now pretty much retired, Bob ran SeerPharma (UK) for twenty years.

Luke Palmer is a Senior Validation Engineer at MTL Projects.

Luke has five years of experience in the pharmaceutical industry: two of which were in manufacturing of single use sterile products, with three being in Validation, primarily Sterilisation in Place and Autoclave Qualifications.

MTL Projects Ltd. is an Engineering and CQV company, specialising in sterilisation, depyrogenation, thermal system monitoring, hydrogen peroxide systems, and steam quality testing.

Magnus Jahnsson is Director of Training and Courses at Key2Compliance.

Magnus has worked in the pharmaceutical industry for almost thirty years. During this time, he has worked both for the industry and for a regulatory authority.

He has held positions in Research & Development, Manufacturing Operations, Quality Assurance and Regulatory Affairs, working both as a manager and a specialist.

Previous positions include:

• Scientific Administrator in the Inspections Sector at the European Medicines Agency.
• Director Regulatory Affairs at Pharmadule Morimatsu.
• Project manager in R&D and manufacturing operations at AstraZeneca.

Magnus is an experienced trainer and has given a number of lectures and courses on various aspects of GMP and regulatory compliance for ISPE and other organisations. He has lectured on four continents and is also an experienced GMP and ISO-auditor.

Andreas Hablesreiter, Senior Pharma Expert, is Project Lead at Innerspace – The Simulator Company.

Andreas is educated as a Pharmaceutical Technician and possesses more than 35 years of working experience in the pharmaceutical industry. He has worked in various positions in sterile production departments:

• Leading aseptic filling department of an aseptic processing site in Austria.
• Responsible for validation and qualification as well as training of personnel.
• Lead and co-auditor in auditing Gxp suppliers.

Project experience includes:

• Leading a variety of projects of implementing new aseptic filling machinery.
• Project lead for implementation of VR-Simulator Training from Innerspace at Takeda Austria.
• He work in the methodology team on a risk-based approach for the development of future modules and on the strategic orientation of our portfolio.

In addition, Andreas is at clients’ sites for demo events and workshops in order to find the best possible fit for their future training program.

Enrique Riis is Nordic Manager at Ellab A/S with headquarters in Denmark.

Ellab provides validation and monitoring equipment as well as GMP consulting, Thermal Validation, and calibration services to the life science industry.

Enrique has a B.Sc. in Global Business Engineering and a Graduate Diploma in Business Administration. Enrique has more than 20 years’ experience gathered from his work with the medical device and pharmaceutical industries, based out of Ellab’s offices in the United States and Denmark. This has allowed him to accumulate knowledge of how to apply Ellab’s solutions in for instance sterilization processes, freeze drying, and cold storage

Since the beginning of 2020 Jana-Cathrien Müller works as Sales Manager at Atec Pharmatechnik

GmbH, Germany, where she is responsible especially for the markets in North and South America.

Atec manufactures pharmaceutical processing equipment, such as formulation systems, vessels, CIP/SIP systems, clean room lifts, component processing systems (stoppers, caps, combi-seals etc.), and sterile transfer solutions.

Previously, she worked for GEA Group as project engineer and manager for pharma and

healthcare solutions, mostly in API processing.

She is holding a master degree in Biotechnology and Process Engineering.
She is a passionate traveler preferably with the camper van and in 2016 she travelled around the world.