Aseptic Academy has chosen very carefully its trainers.
All of them have a deep and thorough knowledge of the “aseptic world”, they all have lived the difficulties during their professional careers, as well as the challenges.
Founder of NOSIS
Main Consultant of NOSIS GMP Compliance and Quality Partners, a consulting company for the GMP regulated sectors
Chemical Engineer from URLl (Universidad Ramón Llull) at the IQS (Institut Químic de Sarrià)
Over 30 years of experience in the EU and US cGMPs regulated environments in both site-operational and corporate positions with Boehringer Ingelheim.
Major accomplishments include designing and constructing a new greenfield site as well as site improvement projects, leading GMP Quality Systems improvement projects, ensuring they are compliant with the regulations and the authorities’ expectations, and 15 years of conducting auditing GMP-related companies worldwide for both human and veterinary products.
Passionate for the sterile world, particularly in aseptic processing be it liquid or Freeze-Dried products.
Associate Director at Boehringer Ingelheim
Certified Training Director and Quality Compliance Sr. in Boehringer Ingelheim. Professional with broad training management.
Degrees in Microbiology and Latin American Studies from the University of Pittsburgh, managed QA, Microbiology QC, Global Compliance Audit, Consulting and Training functions
Over 30 year’s extensive training and development. Personnel and project management experience with Bayer, Mylan, and Boehringer Ingelheim pharmaceutical companies.
Major accomplishments include development, implementation and management of several major global quality, safety and training programs such as GMP Auditor, Qualified Trainer (OJT Train the Trainer), Corporate Biosafety, and ASTA (Aseptic Simulation Training).
Broad human and animal health pharmaceutical experience with a focus on aseptic processing of parenteral drugs and vaccines
Manage and direct training department activities, programs, personnel, policy and practices, including curriculum development. Training module design, delivery and management
Besides their excellent professional background, they are excellent trainers, able to motivate the attendants, making them to participate and to work in the practical exercises.
Founder of Claudia Sigg Consultancy
Principal Consultant and founder of Claudia Sigg Consulting company for the GMP regulated sector.
Degree in Pharmaceutical Chemistry at the NTA Prof. Dr.Grübler, Isny.
Responsibilities for strategic and tactical planning and execution for quality in FDA-regulated companies serving global markets. Responsible for establishing and maintaining global quality processes, ensuring functional performance, driving continuous improvement, ensuring oversight and governance for global quality systems, and establishing regulatory risk management. Part of many major capital investment projects for both modernizations of existing facilities as well as construction of new Greenfield sites.
Major accomplishments include development and implementation of FDA Warning Letter remediation programs of a Corporate Quality Culture program across 20+ manufacturing sites and all hierarchy levels and of Third Party and Product Oversight programs
Passionate about a culture of quality especially in aseptic manufacturing and biotechnology.
CEO & Founder of COMSER
CEO at COMSER, consulting company for the GMP regulated sector.
Degree in Chemical Engineering from the ETSE (UAB).
Associate professor at the Polytechnic University of Catalonia (UPC) from 2008 to 2015 integrated into the business management department.
More than 20 years serving the GMP regulated industry and medical device manufacturing companies through the qualification of equipment and facilities and validation of computer systems according to GAMP 5
Expert in Freeze Dryers and development of lyophilization processes under aseptic conditions.
GMP consultant and trainer at COMSER
GMP consultant for Qualifications/Vaidations and Trainer for GMP regulated industries.
Biology Degree from USAL, MSc and MBA in pharmaceutical industry
Experience as GMP consultant and Qualification & Validation technician. Main roles: qualification of equipment and facilities, validation of methods and processes, Validation of computer systems according to GAMP 5
Passionate about teaching and sharing the importance about quality in the pharmaceutical world.