This chapter is taken from the book Risk-Based Compliance Handbook
Readers may well be familiar with the concept of risk management but not necessarily so with the concept of Process Analytical Technology (PAT). As this
book is addressing risk from a lifecycle perspective, which in turn requires a profound understanding of the processes, and more importantly the quality
attributes of the product, it is obvious that PAT needs to be addressed in this context.
Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: Digital PDF (1 file - 112 KB)
About the Authors
Siegfried Schmitt, Principal Consultant, joined PAREXEL
Consulting in 2007. He provides consulting services to the medical device and
pharmaceutical industry on all aspects of regulatory compliance, particularly
the design and implementation of Quality Management Systems and Competitive
Compliance. Dr Schmitt`s areas of expertise include all aspects of quality and
compliance for the product lifecycle, from R&D, to clinical trials, to
commercialisation and post-marketing studies. He has previously held positions
in industry as Senior Production Chemist with Roche and global Quality Director
with GE Healthcare, and as Validation Manager with Raytheon and Senior Lead
Consultant with ABB. Dr Schmitt is an active member of various industry
associations, including DIA, PDA, RAPS and ISPE, conference presenter and
organiser of international events. He is also an accomplished author and editor,
having won the coveted `distinguished PDA author / editor award` for 2008.
Dr
Schmitt is a Chemist by background and holds Chartered Chemist and Chartered
Scientist status. He is fluent in English and German. He is the author of The
Manager`s Validation Handbook: Strategic Tools for Applying Six Sigma to
Validation Compliance and Understanding
Active Pharmaceutical Ingredients.
Jennifer Thompson (previously Methfessel) is an IT and
computer systems compliance expert with more than 15 years of experience across
a wide range healthcare companies, system suppliers and service providers in the
UK, Europe and USA. She joined ABB eight years ago where she is a Principal
Consultant in Validation and Compliance Consultancy and works closedly with the
ABB Process Analytical Technology Centre of Excellence. She has a special
interest in PAT as she has a Ph.D. in physics, specialising in spectroscopic
techniques. She is a Member of the Institute of Physics, chartered physicist and
has a Diploma in Business Management. An active member of ISPE and GAMP, she
regularly writes articles and presents at international conferences. Jennifer
particularly enjoys applying her business knowledge and scientific training in
working with clients to develop and implement risk-based strategies for PAT,
business systems and IT and computerised systems compliance, validation and
qualification.