Regulatory Compliance Training in Bio/Chemical Engineering Courses

Arthur Felse

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Conference: 2012 ASEE Annual Conference & Exposition
Location: San Antonio, Texas
Publication Date: June 10, 2012
Start Date: June 10, 2012
End Date: June 13, 2012
ISSN: 2153-5965
Conference Session: New Classrooms, New Challenges I: Novel Approaches to Courses
Tagged Division: Chemical Engineering
Page Count: 13
Page Numbers: 25.1111.1 - 25.1111.13
DOI: 10.18260/1-2--21868
Permanent URL: https://peer.asee.org/21868
Download Count: 436

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Arthur Felse Northwestern University

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P. Arthur Felse is a lecturer in the master's of biotechnology program and the Department of Chemical & Biological Engineering at Northwestern University. His responsibilities include teaching, student advising, coordinating master’s research training, and managing the biotechnology teaching laboratory. Before joining Northwestern University, Felse completed his postdoctoral training at the Polytechnic Institute of New York University, where he was awarded a NSF fellowship. He and his colleagues at Polytechnic Institute received the EPA’s Presidential Green Chemistry Challenge Award in 2003 for their work on mild and selective polymerizations using lipases.

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Abstract

Regulatory Compliance Training in Bio/Chemical Engineering CoursesRegulatory compliance (RC) refers to a set of federally mandated guidelines under whichindustrial processes and scientific experiments are planned, conducted, monitored, recorded, andreported. RC is typically achieved through Good X Practices (or GXP) guidelines where X canbe Laboratory, Manufacturing, Clinical or Tissue. Executive federal agencies such as the Foodand Drug Administration and the Environmental Protection Agency are responsible formonitoring and enforcing regulatory codes and each agency has its own independent GXPguidelines. Direct cost involved in assuring RC can be between 20 – 50% of operating costs andthe penalty of non-compliance can be of the order of several million dollars. Since RCinformation is publically available, non-compliance events can lead to indirect penalties throughloss of investor funding and lack of confidence in the general population.Regulatory compliance is an inseparable part of the chemical/pharma/biotech industry. A strongworking relationship between engineers, RC personnel and regulating agencies is crucial anenterprise to thrive in these areas. Consequently, a successful career for bio/chemical engineerswill require an adequate functional knowledge of RC guidelines. With many engineers migratingto highly regulated industries, training in RC compliance is necessary and appropriate inbio/chemical engineering courses. An exposure to RC guidelines and its implementation can helpchemical engineering students to become more marketable and get a head start with their careers.The purpose of this paper is to describe strategies for inclusion of RC training modules inbio/chemical engineering courses. Training modules can be included in a theory course or in ahands-on laboratory course. Instructional approaches include case-study discussions,brainstorming sessions, role-play exercises, team-based clinics and guest lectures. RC trainingcan be included as a short one-off module or as a comprehensive multi-module exerciseembedded throughout a course. Arguments for alignment of RC training with ABET guidelineswill be presented.This paper will also discuss a unified approach to connect engineering principles, regulatoryguidelines and written communication. Pedagogical methodologies such as case analysis andwriting clinics were used to develop GXP compliant documents. Flexible RC training modulestructures which can be adapted for students at sophomore through graduate levels will bepresented. The only prerequisite is that students have some knowledge of bio/chemical processtechnologies. Since RC is more of a practice than absolute science, assignments and testsdeveloped in this module to reflect the ‘practice’ component will be described in this paper.I WOULD LIKE THIS PAPER TO BE IN A REGULAR SESSION

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Felse, A. (2012, June), Regulatory Compliance Training in Bio/Chemical Engineering Courses Paper presented at 2012 ASEE Annual Conference & Exposition, San Antonio, Texas. 10.18260/1-2--21868

TY - CPAPER
AB - Regulatory Compliance Training in Bio/Chemical Engineering CoursesRegulatory compliance (RC) refers to a set of federally mandated guidelines under whichindustrial processes and scientific experiments are planned, conducted, monitored, recorded, andreported. RC is typically achieved through Good X Practices (or GXP) guidelines where X canbe Laboratory, Manufacturing, Clinical or Tissue. Executive federal agencies such as the Foodand Drug Administration and the Environmental Protection Agency are responsible formonitoring and enforcing regulatory codes and each agency has its own independent GXPguidelines. Direct cost involved in assuring RC can be between 20 – 50% of operating costs andthe penalty of non-compliance can be of the order of several million dollars. Since RCinformation is publically available, non-compliance events can lead to indirect penalties throughloss of investor funding and lack of confidence in the general population.Regulatory compliance is an inseparable part of the chemical/pharma/biotech industry. A strongworking relationship between engineers, RC personnel and regulating agencies is crucial anenterprise to thrive in these areas. Consequently, a successful career for bio/chemical engineerswill require an adequate functional knowledge of RC guidelines. With many engineers migratingto highly regulated industries, training in RC compliance is necessary and appropriate inbio/chemical engineering courses. An exposure to RC guidelines and its implementation can helpchemical engineering students to become more marketable and get a head start with their careers.The purpose of this paper is to describe strategies for inclusion of RC training modules inbio/chemical engineering courses. Training modules can be included in a theory course or in ahands-on laboratory course. Instructional approaches include case-study discussions,brainstorming sessions, role-play exercises, team-based clinics and guest lectures. RC trainingcan be included as a short one-off module or as a comprehensive multi-module exerciseembedded throughout a course. Arguments for alignment of RC training with ABET guidelineswill be presented.This paper will also discuss a unified approach to connect engineering principles, regulatoryguidelines and written communication. Pedagogical methodologies such as case analysis andwriting clinics were used to develop GXP compliant documents. Flexible RC training modulestructures which can be adapted for students at sophomore through graduate levels will bepresented. The only prerequisite is that students have some knowledge of bio/chemical processtechnologies. Since RC is more of a practice than absolute science, assignments and testsdeveloped in this module to reflect the ‘practice’ component will be described in this paper.I WOULD LIKE THIS PAPER TO BE IN A REGULAR SESSION
AU - Arthur Felse
CY - San Antonio, Texas
DA - 2012/06/10
PB - ASEE Conferences
TI - Regulatory Compliance Training in Bio/Chemical Engineering Courses
UR - https://peer.asee.org/21868
DO - 10.18260/1-2--21868
ER -