PME 530:Introduction to Pharmaceutical Manufacturing
Pharmaceutical manufacturing is vital to the success of the technical operations of a pharmaceutical company. This course is approached from the need to balance company economic considerations with the regulatory compliance requirements of safety, effectiveness, identity, strength, quality, and purity of the products manufactured for distribution and sale by the company. Overview of chemical and biotech process technology and equipment; dosage forms and finishing systems; facility engineering; health, safety, and environment concepts; and regulatory issues.
PME 540:Validation and Regulatory Affairs in Pharmaceutical Manufacturing
An introduction to validation concepts in plant, process, clean-up, sterilization, filtration, analytical methods, and computer systems. Learn about Good Automated Manufacturing Practice (GAMP), IEEESQAP, and new electronic requirements, such as 21 CFR Part 11. Explore master validation plans, IQ, OQ, and PQ protocols, and their relationships to GMP. Become familiar with FDA and international (EU) regulations governing current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP).
Computers and computerized systems are ubiquitous in pharmaceutical manufacturing. Validation of these systems is essential to assure public safety and compliance with appropriate regulatory issues regarding validation: GMP, GCP, 21CFR Part 11, etc. This course covers validation concepts for various classes of computerized systems and applications used in the pharmaceutical industry; importance of requirements engineering in validation; test protocols and design; organizational maturity considerations.
PME 640:Contemporary Concepts in Pharmaceutical Validation
Current and evolving validation concepts and standards in pharmaceutical manufacturing, including FDAs GMPs for 21st Century, Risk Assessments (Risk-MaPP, ICH Q7a-Q10, FMEA) and statistics in validation, Commissioning and Qualification (ISPE and ASTM), Computer Systems Validation, Cleaning Validation, Spreadsheet Validation, Lean Manufacturing and Six Sigma, PAT initiative, Equipment Qualification vs. CSV (GAMP and AAPS guidelines). Preparation of draft validation documentation, including master plans, protocols, test procedures and reports. Focus is on concepts and principles required to implement these new qualification and validation approaches in a pharmaceutical manufacturing environment in compliance with FDA and international regulations. Needs knowledge of basic statistics concepts.
PME 555:Lean Six Sigma in the Pharmaceutical Industry
Course explores the current application of Lean Six Sigma in Pharmaceutical Manufacturing. Topics covered include: Lean Six Sigma Concepts and Techniques, Project and Team Dynamics, Tools of Lean Six Sigma and their Application, and Designing Pharmaceutical Processes for Lean Six Sigma. Emphasis is on DMAIC, including Define, Measure, Analyze, Improve, and Control methodology, with the students’ skill set developed through case studies and project work on actual pharmaceutical processes using statistical software (Minitab). At the conclusion of this course, students will understand the concepts and principles of Lean Six Sigma, be competent with Minitab software and be able to apply these techniques to pharmaceutical processes.
Professor Walsh founded SPRC in the summer of 2009 with 1 full time and 2 part time Research Assistants working on Total Organic Carbon Analysis and Visual Inspection for Cleaning Validation and developing lab practicals for PME courses. Additional areas of research have been added since, including the PAT application of TOC in CIP systems and automation of electronic GMP systems. SPRC has grown quickly to more than 50 ongoing projects, which resulted in 12 posters presented at the 1st Annual SPRC Poster Show on June 15, 2011. 6 of these posters were entered into the NJ-ISPE Student Poster Competition and 1 poster won Best Stevens Graduate Poster. SPRC also presented posters at the Stevens Graduate Research Conference in 2009 (1 poster), 2010 (2 posters) and 2011 (4 posters). SPRC's research efforts are supported by a number of corporate donors including General Electric (Sievers), Waters-ERA, Ecolabs, Texwipe, Alconox, Testos, and Glaxo Smith Kline. In addition, funded research has been provided from AMCOL Health and Beauty Aids, C.R. Bard, and Waters-ERA.
Experience & Service
Experience
Over 20 years of Pharmaceutical Industry in Validation at three Johnson & Johnson companies, Schering-Plough and Hoffmann-La Roche.
Training and Consulting to the Pharmaceutical Industry on application of Lean and Six Sigma principles to Cleaning Process Development and Validation since 2007 (Clean6Sigma, LLC)
Andrew is an Industry Professor in the Pharmaceutical Manufacturing and Engineering Graduate Program and teaches courses in Pharmaceutical Validation and Lean Six Sigma. Andrew is a certified Lean Six Sigma Black Belt and an Accredited Training Associate through the International Association of Six Sigma Certification.
Andrew has over 20 years of "hands-on" Validation experience working in the Pharmaceutical Industry in Equipment and Utility Qualification, Process Validation, Cleaning Validation, Analytical Method Validation, Spreadsheet Validation and Computer Systems Validation. Prior to working in the Pharmaceutical Industy, Andrew had 10 years of prior experience working as an Analytical Chemist and Microbiologist with the Colgate-Palmolive and Clorox companies.
Andrew is also the founder and president of Clean6Sigma, LLC a consulting firm providing training and consulting on the application of Lean and Six Sigma principles to Cleaning Process Development and Cleaning Validation and on using statistics and risk assessment for developing and evaluating cleaning processes. Andy has provided training and consulting to large and small pharmaceutical companies including Actavis, Bristol-Meyers Squibb, Novartis and Johnson and Johnson.
Consulting Service
Provides consulting services to the Pharmaceutical Industry through Clean6Sigma, LLC (www.clean6sigma.com) and through the Stevens Pharmaceutical Research Center in Cleaning Process Development, Cleaning Validation Method Development and Total Organic Carbon Analysis
Professional Service
Team Member and author of ISPE’s Risk-based Manufacture of Pharmaceutical Products Guideline (Risk-MaPP)- published Fall 2010
Team Leader and principle author of ISPE’s Science and Risk-based Cleaning and Cleaning Validation Guideline - in progress
Team Leader and principle author of ASTM’s Cleaning Development and Cleaning Validation Standard - in progress
NJ-ISPE Board of Directors 2008-2011
Institutional Service
Advisor to the Stevens Pharmaceutical Research Center (SPRC) Graduate Club.
Achievements & Professional Societies
Honors & Awards
Winner of ISPE Committee of the Year for 2010 - Risk-MaPP (Risk-based Manufacture of Pharmaceutical Products) Task Team Member
Professional Societies
International Society of Pharmaceutical Engineers American Society for Testing and Materials American Society for Quality Regulatory Affairs Professionals Society
Selected Publications
Journals
Walsh, Andrew. (2011). "Cleaning Validation for the 21st Century: Overview of the New ISPE Cleaning Guide", Pharmaceutical Engineering, November/December 2011. Vol. 31 (No. 6), Download (470 kb PDF).
Walsh, Andrew. (2011). "Cleaning Validation for the 21st Century: Acceptance Limits for Active Pharmaceutical Ingredients (APIs): Part II", Pharmaceutical Engineering, September/October 2011. Vol. 31 (No. 5), Download (1514 kb PDF).
Walsh, Andrew. (2011). "Cleaning Validation for the 21st Century: Acceptance Limits for Active Pharmaceutical Ingredients (APIs): Part I", Pharmaceutical Engineering, July/August 2011. Vol. 31 (No. 4), Download (1174 kb PDF).
Conference Proceedings
Andrew Walsh. "Leader of “Cleaning for the 21st Century” Program", International Society of Pharmaceutical Engineers Conference Washington D.C. June 2008.
Andrew Walsh. "Co-Leader of ISPE Risk-MaPP Program", International Society of Pharmaceutical Engineers Conference Washington D.C. June 2007.
Book Chapters
Andrew Walsh. (2011). "Microbial Aspects in Cleaning Validation", Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices , Madhu Raju Saghee, Tim Sandle and Edward C. Tidswell, Business Horizons.
