Hosam Aleem is currently working towards his PhD in Biotechnology at the School of Chemical Engineering & Analytical Science, University of Manchester in the UK. He has graduate degrees in Electrical Engineering from the University of Missouri – Rolla and the University of Southern California, and an MSc in Biotechnology from the University of Manchester Institute of Science & Technology (UMIST). He has spent several years in the pharmaceutical industry as a Validation & Calibration engineer at both IPR owners and contract manufacturers. Prior to that, he worked as an Instrumentation & Process Control engineer in the oil & gas industry. He can be reached by email at hosam.aleem@manchester.ac.uk
Michael Anisfeld is President of Globepharm Consulting, Inc., and has over 30 years experience in all GMP aspects of the pharmaceutical industry (sterile and non-sterile). He can be contacted by phone at USA +1 847 914 0922, or by e-mail at manisfeld@globepharm.org
Gamal Amer, Ph.D.
Gamal Amer, Ph. D. is Senior Director of Technology and Regulatory Compliance at BE&K Engineering. He holds a Ph. D. in Chemical Engineering and has over 25 years of experience in the Pharmaceutical and related industries. He has held senior management positions with leading pharmaceutical, consumer product and engineering consulting firms over the years. His experience includes comprehensive process design in bulk pharmaceutical manufacturing, biotechnology manufacturing, pharmaceutical solid dosage manufacturing and containment of potent and radioactive therapeutics. He is also experienced with facility development for therapeutic products operations. Dr. Amer is a recognized expert in GMP compliance and validation. He has consulted for many of the leading pharmaceutical, biotechnology and medical device manufacturers. He has written many articles in peer reviewed publications, lectured extensively in the US, Europe, Asia and the Middle East, and taught many courses. He is a member of ISPE, PDA, ACS and AIChE.
Emma Barsky
Ms. Barsky leverages her proven expertise in the areas of GXP Quality Assurance and Project Management. Since the time the business was launched, Ms. Barsky has performed multiple overall quality and computer validation assessments, conducted multiple field investigations, helped start-up companies to build a quality infrastructure in order to successfully pass client audits, and managed multiple projects that required the assistance of subcontractors. She can be reached at 609.683.0756 or at ebarsky@practicalsolutionsnj.com.
John F. Bauer
John F. Bauer, PhD, is president of Consult JB LLC Pharmaceutical Consultants. Dr. Bauer has more than 30 years pharmaceutical industry experience, including work in solid state chemistry, analytical chemistry, stability, pharmaceutics, regulatory CMC, patents, and litigation. He may be reached at 847-738-0856 and at consultjb@comcast.net.
Rebecca Brewer
Rebecca Brewer is the director of consultancy services, validation & GMP compliance for Dober. Dober manufactures cleaning agents for the pharmaceutical, biopharmaceutical, nutraceutical, cosmetic and medical device industries. Becky's more than 20 years experience in the pharmaceutical industry have been dedicated to validation and compliance, with a strong emphasis in cleaning and cleaning validation. Her prior employment was with Raytheon Engineers & Constructors (now Washington Group) and Bristol-Myers Squibb. She routinely teaches cleaning validation for ISPE, ASME, and University of Wisconsin in addition to helping to develop the cleaning validation program for IVT. Rebecca can be reached by e-mail at RBrewer@dober-group.com.
Kevin Bull Chief Executive Officer, Veriteq Instruments
With a background of 30 years in commercial test and development, Kevin Bull has been the CEO of Veriteq Instruments for 12 years, designing innovative solutions for measuring temperature and humidity. He regularly consults on instrumentation with organizations such as the United States Navy and NASA, and frequently shares his knowledge, speaking to a variety of groups including NCSLi (National Conference of Standards Laboratories International), MSC (Measurement Science Conference), ASTM (American Society for Testing and Materials), ISHM (International Symposium on Humidity and Moisture) and the ISPE (International Society for Pharmaceutical Engineering).
Mr. Bull has designed, developed and managed the production of electronic and software systems for industrial environments and specialized in component-level design for large process control systems with thousands of monitored points. His lifelong interest in science and electronics is underscored by his belief that precise measurement creates better products. He is committed to developing industrial measurement systems that improve product quality, reduce liability, safeguard assets and protect people.
Jennifer Carlson
Jenna Carlson is a Senior Technical Manager in Genentech’s Corporate Quality System and Support, Validation department. She is responsible for developing and overseeing governance activities for cleaning validation, including the corporate requirements and procedures. She has over eleven years experience focusing on validation and quality assurance. Jenna has held key roles at leading biotechnology firms including Allergan, Baxter, and BioMarin focusing on validation of equipment, cleaning, process, and methods. She is an author and team member of the PDA task force developing the new Point to Consider for Biotechnology Cleaning Validation. Jenna is also a chapter author in Cleaning & Cleaning Validation for the Pharmaceutical & Medical Device Industries Vol. 1. Basics, Expectations, and Principles. Jenna earned her Bachelor of Science in Chemistry from Southern Illinois University.
Pramote Cholayudth
Pramote Cholayudth is Validation Consultant to Biolab, one of the top five leading pharmaceutical manufacturers in Thailand, and Executive Director of Valitech, a well-established GMP and validation service firm to pharmaceutical industry. He is a guest speaker on Process Validation to the industry organized by local FDA. He was a lecturer in a university for 4 years (1998-2001). Prior to entering academic arena, he spent 23 years in the pharmaceutical industry. He can be contacted by fax at 662-740-9586, by e-mail at cpramote2000@yahoo.com, or the following address:
Pramote Cholayudth 6/756 Number One Complex, Bangkok-Ram 2 Road, Pravate District, Bangkok, 10250 Thailand
William V. Collentro
William V. Collentro is a Senior Consultant and founder of Water Consulting Specialists, Inc., Doylestown, PA (www. waterconsultingspecialists.com), and has more than 40 years experience in water purification. He holds both a B.S. and M.S. in Chemical Engineering from Worcester Polytechnic Institute. Mr. Collentro is an adjunct professor at Stevens Institute, and a member of the PDA-TRI Faculty. He has published numerous articles discussing pharmaceutical water systems and is a member of several professional organizations including PDA, ISPE, ACS, AIChE, and AWWA. He may be reached at wcsi38@aol.com.
David Dills
Mr. David R. Dills is a consultant with more than 19 years of hands-on experience in the FDA-regulated industry, with emphasis on Class I, II, III medical device and pharmaceutical/biologics operations in the areas of regulatory affairs, compliance, software and process-related validation, quality engineering and quality systems to ensure compliance with FDA and international regulations. Mr. Dills also served as Director of Publications, Regulatory & Compliance for the Institute of Validation Technology. He provides contracted services in the areas of regulatory affairs, including submissions to the Agency, including IDE/PMA/NDA and CMC, auditing, internal assessments, compliance, quality system regulation (QSR), GXP compliance, CE Mark activities, MDD 93/42/EEC compliance, ISO 13485/ISO 14971, Risk Management, Inspection Readiness Preparedness and Training, Agency enforcement action activities as necessary and other prescribed quality related services and consultation on behalf of medical device, pharmaceutical, and biologics/biotech companies. He can be reached in Jacksonville, FL at (office) 904-519-8040, (mobile) 904-614-3220 at drdills@bellsouth.net.
Walter Dziki, Ph.D.
Walter Dziki, Ph.D., is an associate research fellow in global pharmaceutical and analytical sciences in Global Pharmaceutical Research and Development of Abbott Laboratories. His responsibilities include the physical and chemical characterization of active pharmaceutical ingredients (APIs), excipients, and drug products in Abbott for the last 18 years. He is currently evaluating new analytical technology for the process analytical technology (PAT) initiative at Abbott, and is assisting in implementing PAT in pharmaceutical development and manufacturing. He is also involved with improving and making more efficient analytical testing procedures, and rapid prediction of physical stability of APIs, excipients, and drug products. He can be reached at walter.dziki@abbott.com.
Rodger Edwards graduated with a BSc (Honours) in Metallurgy and Materials Science from the joint UMIST/University of Manchester Department of Metallurgy. He then joined the department of Building Engineering at UMIST as a research assistant with his main research areas being the measurement of ventilation rates using tracer gases and the computer simulation of hot water systems. He obtained his PhD from the same department and has been a lecturer, then senior lecturer there since then. After the merger of UMIST and the University of Manchester, he is now a senior lecturer at the School of Mechanical, Aerospace and Civil Engineering in the joint university.
Edwards was elected to corporate membership of the Chartered Institution of Building Services Engineers (CIBSE) in 1997 and is currently Chairman of its Merseyside and North Wales Region of CIBSE.
Edwards has been the Director of the Pharmaceutical Engineering Advanced Training (PEAT) program since December 1996, and has supervised more than 50 successful MSc graduates through their dissertations. He can be reached by email at rodger.edwards@manchester.ac.uk.
Kurtis Epp
As a consultant with BioTechLogic, Inc., Kurtis Epp provides project management and manufacturing support for clients with biopharmaceutical products in clinical development or on the commercial market. He has managed validation activities for multiple products that have been approved in the U.S. and in Europe. He spent four years with Pfizer (previously G.D. Searle and then Pharmacia) in fermentation research and development, three years with Pfizer in Manufacturing Management, and the past four years with BioTechLogic, Inc. as a consultant. His expertise lies in the areas of technology transfer, process risk assessment, process validation, process comparability, contract manufacturing management, and regulatory writing. Kurtis can be reached at kepp@biotechlogic.com.
Tim Fields
Tim Fields, President of Drumbeat Dimensions, Inc. (DBD), has over 25 years of experience in the pharmaceutical industry including 13 years with Pfizer where he was responsible for organizing and managing the corporate software quality assurance audit program, developing GMP training programs for management level personnel, and conducting numerous internal and external quality audits.
Mr. Fields has experience in a variety of compliance areas including sterilization validation, aseptic processing, computerized system validation, process validation, cleaning validation, GMP training, 21CFR Part 11, document management, calibration, and auditing.
Mr. Fields is a member of the International Society of Pharmaceutical Engineers (ISPE), Parenteral Drug Association (PDA), and GAMP Americas. He has published and lectured worldwide on various compliance-related topics including computer-related system validation, electronic signatures and records, document management, validation, and GMPs.
Mr. Fields is a member of the Editorial Review Board for the Journal of GXP Compliance. He is an adjunct instructor at the Community College of Rhode Island, where he teaches “Introduction to Pharmaceutical Compliance”.
Mr. Fields has a B.A. in Biology from Indiana University and an M.A. in Life Sciences from Indiana State University.
Richard Forsyth
Richard Forsyth is an industry consultant with a background in cleaning validation and analytical chemistry. Mr. Forsyth was previously an associate director of GMP quality at Merck & Co., Inc., where he was responsible for internal and external facility audits as well as document audits for regulatory submissions. He has worked in quality for more than three years and prior to that worked as an analytical chemist in pharmaceutical research and development for 23 years. He has been involved with cleaning validation for more than 15 years.
Mr. Forsyth has a broad range of good manufacturing practice and good laboratory practice analytical experience including methods development and validation, as well as formulation development and project management.
Mr. Forsyth is an adjunct professor in the QA/RA graduate program at Temple University. His academic training includes an MS in chemistry and an MBA in management, both from St. Joseph’s University in Philadelphia, Pennsylvania.
Mr. Forsyth has more than 25 published articles on cleaning validation and analytical topics. He is an internationally-recognized expert in cleaning validation, having spoken at conferences in the US, Europe, and Japan. His most recent work involved the quantitative development and implementation of visible residue limits for cleaning validation.
Nellie has close to 25 years experience in the pharmaceutical industry. For the past few years, she has worked for Research Pharmaceutical Services (RPS) performing CMC Regulatory Affairs and regulatory/technical writing assignments for various pharmaceutical and biopharmaceutical companies. Before that, for almost 18 years, she was employed by DuPont Pharmaceuticals working in a diverse range of departments including Quality Assurance, Regulatory Affairs and Safety Assessment.
While working for DuPont Pharmaceuticals, Nellie received training for and became certified as a Six Sigma Master Black Belt. She received her Masters of Science degree from Lehigh University in Quality Engineering, and is currently working for RPS as a regulatory writer.
Nellie has contributed to the knowledge base of the pharmaceutical industry in several ways. She has presented at the GMP by the Sea, was a guest lecturer at Lehigh University, and has presented numerous times for the Institute of Validation Technology (IVT). She has had several articles published in The Journal of GXP Compliance, and was the co-author of the chapter “Change Control and SUPAC” in Pharmaceutical Process Validation, Third Edition. She has also been a member of the Editorial Advisory Board of the Journal of GXP Compliance since 2000.
Armin Gerhardt
Armin Gerhardt, Ph.D, is an industry consultant who spent more than 16 years at Abbott split between formulation services for R&D and project management for new drug development teams. Armin retired from Abbott in 2007. He can be reached at arminhg@comcast.net.
Karen Ginsbury
Karen Ginsbury is president of PCI Pharmaceutical Consulting Israel Ltd., a consulting firm that provides services to the pharmaceutical industry in the fields of quality assurance, GMP, and compliance. Karen is a pharmacist and a registered member of the Royal Pharmaceutical Society of Great Britain, as well as holding a second degree in Microbiology. With many years of hands-on experience working within the pharmaceutical industry, Karen has been in the field of quality assurance for over 20 years. She has helped companies set up, maintain, and continuously improve quality systems that have successfully passed US FDA, EU, Health Canada inspections as well as other regulators. Karen’s particular fields of expertise are general compliance issues, cleanrooms, and manufacture and control of investigational drugs. Karen can be reached by e-mail at kstaylor@netvision.net.il.
Megan K. Gladfelter
Megan brings to Kymanox previous experience in various Quality Assurance roles at Abbott Laboratories, supporting both commercial manufacturing and R&D. Megan has experience applying Lean Six Sigma on process improvement projects to reduce non-value added steps and improve throughput. Megan has proven skills to organize and analyze metrics to support world-class, integrated quality systems with the emphasis on customer satisfaction. Additionally, Megan is an experienced presenter and facilitator, having delivered presentations to upper level management, engineering design clients, and for training. Megan holds a bachelor’s degree in Biomedical Engineering, with a specialization in Biotechnology, from Northwestern University. Megan is a member of the Society of Women Engineers (SWE).
Anne Greene
Anne Greene worked for several years in technical roles for Sterling Winthrop, and Wyeth Medica Ireland before joining the Dublin Institute of Technology as a lecturer in Pharmaceutical Chemistry. She currently is Programme Director for the MSc in Pharmaceutical Validation Technology programme in DIT. She can be reached at anne.greene@dit.ie.
Cynthia (Cindy) Green, RAC
Cindy has been working with regulated industry for nearly 35 years holding senior positions in regulatory, quality assurance and quality control for several biotechnology and medical device companies and has been President of her own consulting company for the past 16 years. She has over 30 years of technical, regulatory, and quality experience with additional 4 years of “hands on” research and development experience. She has organized and established GMP/GCP/GLP/GTP compliance programs, managed a full range of regulatory submissions for drug, medical device, and biologic products; international submissions and export applications; validation plans; and environmental control programs for multi-use facilities. In addition, she has conducted an extensive number of internal, supplier, and contract manufacturing audits worldwide as well as conducted a number of quality audits for GLP, GCP, and GTP. She has worked with companies while either under consent degree or warning letter to assist them with compliance improvement and the filing of response letters. She has extensive international experience having worked with clients in Europe (Finland, Norway, Sweden, and Germany), Asia (Japan, Taiwan, Hong Kong, and China) and Australia.
Ms. Green holds a Bachelor of Science degree in bacteriology and public health from Washington State University and was certified in Regulatory Affairs in 1993. She is a member of numerous professional associations and has been an Editorial Board Member for the Institution of Validation Technology since 1995.
Len Grunbaum
Mr. Grunbaum is a recognized expert in the industry, particularly in the areas of Validation, Quality Assurance, and compliance with 21 CFR part 11 (the electronic records/electronic signatures final rule). He has written extensively on these subjects and has delivered numerous tutorials and training sessions to clients and industry groups. He has also provided validation and compliance enforcement training to the FDA and developed quality plans and validation strategies for software companies planning to begin operations in the Pharmaceutical industry or to work with pharmaceutical clients. He can be reached at 609.683.0756 or at lgrunbaum@practicalsolutionsnj.com.
John Haury
John Haury is a Principal Consultant with www.Applied-Stats.com. He can be reached at jhaury@applied-stats.com.
Eldon Henson
Eldon Henson is a frequent contributor to Institute of Validation Technology publications. He has authored IVT’s Auditing Handbook, Quality Improvement Handbook, Topic of the Day GMP Training Program, the GMP Toolbox, cGMP Perspectives and Approaches for Sampling, and, most recently, Re-establishing a Culture of Compliance. He has also written numerous other articles on topics such as laboratory operations, internal audit programs, annual product reviews, document control, training, and validation topics. Henson is a member of the Editorial Advisory Board of the Journal of Validation Technology and has written many GMP training modules for Eduneering (see www.eduneering.com), a web-based training content provider. He holds B.A. and M.A. degrees in microbiology from Southern Illinois University-Carbondale and has worked primarily in quality and compliance roles at Abbott Laboratories, Boehringer-Ingelheim, Novartis, and others, and is currently Director of Quality, Pharmaceutical Products at Covidien (formerly Mallinckrodt Tyco) in Hazelwood, Mo. Henson can be reached at eldon.henson@covidien.com or henson333@hotmail.com.
Rachel Houp
Rachel C. Houp is a consultant with BioTechLogic, Inc. She provides project management, manufacturing and CMC support for clients with biopharmaceutical products from development through commercial launch. Rachel can be reached at rhoup@biotechlogic.com.
Melvin F. (Frank) Houston
Melvin F. (Frank) Houston is a Senior Validation Consultant with EduQuest, Inc., a global team of FDA compliance experts based near Washington, D.C. Frank is a recognized authority on ISO 9000 Quality Standards and Quality System Regulation. He has particular expertise in the validation and auditing of computer-controlled systems in regulated industry. He also is considered an expert in software quality assurance and a champion of software/system safety.
Before joining EduQuest, Frank served 12 years with the US FDA Center for Devices and Radiological Health (CDRH), where he influenced the formation and execution of FDA software policies for medical devices and Good Manufacturing Practices. He also develops instructional materials for EduQuest’s popular “FDA Auditing of Computerized Systems and Part 11” training course, next scheduled July 13-15 in Dublin, Ireland, and September 21-23 in St. Paul, MN. For course details and a free copy of the ValidationVaultTM Resource CD distributed to all EduQuest students, e-mail MartinHeavner@EduQuest.net.
John Hyde
John Hyde is Chairman and Founder of JM Hyde Consulting, Inc., a firm of 90 engineers and scientists founded in 1993 and specializing in process and control systems engineering, process and equipment validation, and compliance consulting for biopharmaceutical and pharmaceutical process systems. For nearly two years prior to the formation of JM Hyde Consulting, Inc., John was Senior Project Engineer with Synergen, a biopharmaceutical research and manufacturing company located in Boulder, CO. His work at Synergen included design, start-up and validation of key process systems and the overall responsibility for the cleaning validation programs for the firm's large scale and clinical manufacturing facilities. From 1982 to 1992, John was Manager, Process Design with Seiberling Associates, Inc., an engineering firm specializing in the design and start-up of hygienic process systems and the application of CIP technology. He has presented papers at numerous engineering conferences and short courses on topics including biopharmaceutical process systems design, automatic cleaning system design and implementation, and control system design for pharmaceutical processes, and he has published ten articles on these topics. He, as a member of the PDA Subcommittee for Biopharmaceutical Cleaning Validation, contributed two chapters to a book on the subject, and he is completing a book manuscript on CIP technology.
John is a regular speaker on conferences presented by the Society of Bioprocessing Professionals (SBP), Pharmaconference, the Institute of Validation Technology (IVT), the International Society of Pharmaceutical Engineers (ISPE), the American Institute of Chemical Engineers (AIChE) and other professional societies. John has also provided CIP systems training to FDA CBER personnel. He holds Bachelors degrees in Food Science and Business Administration, and a Masters degree in Food Engineering, all from the Ohio State University.
David J. Ingram
David J. Ingram is Director for Baxter’s Business Excellence Program. His team is responsible for helping Baxter organizations implement Baxter’s Business Excellence Model. Elements of the model include organizational strategy and Lean Six Sigma Methods to drive results. Dave has over 25 years experience in the validation and qualification of process equipment and critical systems. He consults extensively with Baxter’s manufacturing facilities and R&D groups regarding application of Six Sigma and validation concepts including areas such as DOE, FMEA, SPC, and Sampling Plans for Inspection and Validation. He is a past examiner and senior examiner for Baxter’s internal Baldrige/Shingo assessment program.
Dave received a Bachelor of Science degree in Industrial Engineering from Bradley University, Peoria, Illinois, and a Master of Science degree in Statistics from DePaul University, Chicago, Illinois. He is a Senior Member of the American Society for Quality (ASQ), a Certified Six Sigma Black Belt and a Certified Quality Engineer. He is past education director for the local ASQ section. He has published and presented several papers for ASQ and other professional organizations. He has also published articles for ASQ and for the Institute of Validation Technology (IVT) and currently sits on the IVT Editorial Advisory Board. Dave can be reached by phone at 847-270-4697 and e-mail at ingramd@baxter.com.
Elaine Kelleher
Elaine Kelleher is the Senior Validation Manager for the Sterile Fill Finish Facility at Elan in Athlone, Ireland. Previous to this she held the position of Validation Manager for Elan Drug Technologies (solid dosage) and previous to that was employed by Allergan Pharmaceuticals. In the last 10 years she has worked on a number of validation projects e.g. facility, utility, equipment and computerised system qualification, process validation, cleaning validation, filter validation, qualification of sterilisation and depyrogenation processes and the design and implementation of environmental monitoring and media fill programmes. She has a BSc. from University College Galway, followed by a post graduate diploma in Analytical Chemistry and Biochemistry from UCG. She also holds a Higher Diploma in Modern Management and Employee Relations from National College of Ireland. She has just completed her MSc. in Pharmaceutical Validation Technology in 2007 from the Dublin Institute of Technology. She can be reached at Elaine.Kelleher@elan.com.
Steven Klingenberg
Steven Klingenberg is Director of Validation and a Senior Leadership Team member at Baxter Healthcare Corporation, Baxter Bioscience Division, Thousand Oaks, CA. Mr. Klingenberg is serving his 26th year with the Corporation and has worked in Metrology, Automation, Engineering, and Validation Departments. His department is responsible for the HEPA Certification Program and for performing Airflow Visualization Studies. He can be reached by email at steven_klingenberg@baxter.com.
Jerry (John G.) Lanese is the President of The Lanese Group, an independent consulting organization. He has a Ph.D. in Analytical Chemistry and is a Certified Management Consultant (CMC). Jerry began his career teaching Analytical Chemistry in a small liberal arts college. He moved from the academic environment to the pharmaceutical industry where he has managed Analytical Research, Quality Control and Quality Assurance functions. Since 1994 Dr. Lanese has been a consultant in the area of Quality System and cGMP compliance and has consulted with small and large medical device and pharmaceutical companies, including companies under FDA Consent Decree, API and excipient manufacturers, electronic firms and other manufacturing organizations.
Dr. Lanese lectures throughout the world on a variety of topics related to Quality Systems, GMPs, APIs, laboratory operations, calibration, computer system validation and electronic documentation, change control, deviations and product reviews for national seminar and conference providers. He also provides customized training for his clients. He was named the Best Seminar Presenter of the year 2001 by the Institute of Validation Technology. In 2005, his article “Training and the Laboratories” was selected as best article of year by the Journal of GXP Compliance. Recently, in 2007, Jerry received the Kenneth Chapman Industry Recognition Award for his contributions to the Pharmaceutical industry.
Jerry is a member of the Editorial Boards of the Journal of Validation Technology and Journal of GXP Compliance. He has been active in the Kansas Award for Excellence program for the past fourteen years and has served as Examiner, Lead Examiner and Judge. Dr. Lanese is also a member of American Society for Quality, AOAC and the Institute for Management Consultants.
On the personal side, Jerry is active Toastmasters and is the president of Kansas City Ragtime Revelry, an organization that promotes ragtime music. Jerry can be contacted by phone at 913-491-9234 and e-mail at jerry@lanesegroup.com.
Max Lazar
Max Lazar retired from Hoffmann-La Roche Inc. in 2001 after 35 years, where he was Vice President, FDA & DEA Compliance. In that position he was responsible for compliance oversight of all of the Roche USA businesses including Active Pharmaceutical Ingredients, Pharmaceuticals (Solid, Liquid, and Sterile), R&D, Diagnostics, Fine Chemicals and Vitamins. Following his retirement, he established a consulting business specializing in API GMP issues and the training of personnel covering the ICH Q7A Guidance. As a voting member of the ICH Expert Work Group (EWG) that developed and negotiated this new international standard, Max is uniquely qualified to share and explain the EWG’s intent of this new guidance. His involvement in this new API GMP pre-dates the ICH activity itself.
His more than 40-year career in the Pharmaceutical Industry includes numerous memberships and chairs of committees. He founded and chaired the Pharmaceutical Manufacturers Association’s Bulk Pharmaceutical Committee of the Quality Control Section. This chair lasted thru the reorganization of PMA into PhRMA and until Max’s retirement in 2001. He has presented at numerous meetings and training programs including SOCMA, PDA, DIA, PhRMA, Barnett, and IIR both domestically and overseas.
Max was named Topic Leader for the Pharmaceutical Research and Manufacturers Association’s (PhRMA) ICH Q7A team that developed the API GMP document for ICH. He represented USA industry at the PIC/S Canberra Conference which preceded the ICH API activities and worked with FDA during the 1980 – 2000 era addressing all of the API industry related regulatory issues including the 1987 NDA Re-Write Guidelines and GMP activities. He was one of five invited industry representatives at the WHO/CDC/FDA Diethylene Glycol Contamination Prevention Workshop that followed the Haitian tragedy where almost 100 children died. This workshop developed recommendations for consideration by the Pan American Health Organization and WHO. Max was named as PhRMA’s representative on the FDA PQRI initiative that developed the initial Bulk Substance projects.
He was Vice Chair of the USP Pharmaceutical Waters Expert Committee (2000-2005) and has been re-elected to another 5-year term (2005-2010) as a member on this USP Expert committee. He conducts training and consultations on API GMP (ICH Q7A) and other FDA Compliance issues. While specializing in API, Max’s experience provides him with expertise in many areas of FDA compliance including laboratory, documentation, sterile and oral dosage forms as well as devices, diagnostics and radiopharmaceuticals.
For his contribution to Q7A, he was awarded the USA FDA Commissioner’s Special Citation “For outstanding cooperation and achievement in developing an internationally harmonized good manufacturing practice guidance for active pharmaceutical ingredients used in human drug products.”
He is a member of numerous professional organizations. He is on the Editorial Board of the Journal of GXP Compliance. Max is listed in numerous editions of Who’s Who including Who’s Who in America and is a graduate of Brooklyn College of the City University of New York. He has contributed to several books dealing with APIs, and has written and published several guidances covering Bulk Pharmaceutical Chemicals (API) as chair of the PhRMA and PMA Bulk QC Committee and Workgroups. He is resides in Surprise, AZ. He can be reached at maxslazar@aol.com.
Destin LeBlanc
Destin LeBlanc has over 25 years of technical service and product development experience in specialty chemicals and medical technologies, the last 10 of which have been involved with various aspects of cleaning and cleaning validation in pharmaceutical and medical device manufacturing. He can be reached by e-mail at destin@cleaningvalidation.com.
David LeBlond
David LeBlond obtained an MS in statistics from Colorado State University, a Ph.D. in biochemistry from Michigan State University, and has 29 years experience in the pharmaceutical and medical diagnostics fields at Abbott. He is currently a principal research statistician supporting analytical and pharmaceutical development. He also serves on the CMC statistical expert team in PhRMA. David can be reached at David.LeBlond@abbott.com.
John E. Lincoln
John E. Lincoln is principal of J. E. Lincoln and Associates (www.jelincoln.com), a consulting company with over 28 years experience including 16 years as a full-time consultant, serving US Food and Drug Administration-regulated industries. John has worked with start-up to Fortune 100 companies in the US, Canada, China, France, Germany, Mexico, Sweden, and Taiwan.
John specializes in medical device current good manufacturing practices, systems, and standard operating procedures; product to market, defect, and cycle time reduction; equipment, process, product, and software documentation; validation, quality and regulatory management; product risk and ISO 14971; product clearance and regulatory issues resolution. Mr. Lincoln has worked for such companies as Abbott Laboratories, Mallinckrodt Medical, Hospira, and Integra and has held assignments as vice president of research and development, director of quality assurance, senior quality assurance engineer, and senior manufacturing engineer. He has additional experience in civil and military government, aerospace, and electronics industries.
Mr. Lincoln has published numerous peer-reviewed articles on culture change, training, biohazards, quality, regulatory affairs, corrective action and preventative action, and validation. He conducts webinars, workshops, and training worldwide. He holds a Bachelor of Arts from the University of California-Los Angeles.
John can be contacted by e-mail at jel@jelincoln.com or by phone at 435.882.4655.
David Markovitz
David Markovitz has over three decades of leadership and management experience in the health care industry. Having held positions as Manufacturing Laboratory Manager, Packaging and Filling Manager, Pilot Plant Manager, Manufacturing Engineer, Technical Training Manager, and Corporate Director of Education and Training, he has hands-on experience in effectively managing complexity with limited resources. David’s corporate experience was acquired at Nutrilite Products, SmithKline Beckman, Organon diagnostics, and Ortho Diagnostics. David is the President of GMP Training Systems, an education, training, and consulting firm whose mission is to help organizations improve their productivity, quality, and long-term profitability by implementing strategies focused on innovation, continual improvement and optimization of work systems and processes throughout all levels in an organization. He can be reached at info@GMPTrainingSystems.com.
Tim McCarthy
Tim McCarthy is a Professor of Engineering Design at the University of Wollongong, NSW Australia since 2004. His previous position was as senior lecturer at UMIST, which he joined in 1985; prior to this he worked as a Research Engineer at University College Cork (UCC) where he gained his PhD. In 1994/95, Tim was a Visiting Scholar at Stanford University's Center for Integrated Facilities Engineering. He holds degrees from UCC, Cranfield University and is a Member of the Institution of Engineers of Ireland. His current research interests include Knowledge Management and Information Management in regulated environments. He can be reached by email at timmc@uow.edu.au.
John McConnell
John McConnell is a Brisbane, Australia-based consultant with a client roster that extends from Australia to North America, Europe, and Africa. He has written four books and co-authored a fifth, the latest being Six Sigma in the Pharmaceutical Industry, which provides unique insights into understanding and reducing variation.
John left the Australian Armed Forces in 1982 after more than 13 years service (Royal Australian Engineers). He then became Queensland Manager of Enterprise Australia, the pre-cursor of the Australian Quality Council.
In 1986 he published his first book The Seven Tools of TQC, which became popular as a text in both colleges and businesses. In 1987 his second book, Analysis and Control of Variation was published. In January 1987 he founded Wysowl Pty Ltd. This was followed by the publication of Safer Than A Known Way and Metamorphosis.
John invited Dr. W. E. Deming to Australia in 1988 and ran a four-day seminar in conjunction with him. This became an annual event attended by 300 or so business leaders each year until the death of Dr. Deming. John’s own seminars have been held in Australia, New Zealand, France, England, Ireland, Canada, Mexico, and the USA.
Becky R. McCuen is a consultant with BioTechLogic, Inc. She provides project management, manufacturing and CMC support for clients with biopharmaceutical products from development through commercial launch. Becky can be reached at bmccuen@biotechlogic.com.
Timothy W. Miller
Timothy Miller has worked in cGMP manufacturing for ten years, with experience in all functional areas of production as well as in technology transfer and scale-up. He has contributed to four major capital projects, two of which were new facilities and two of which were major expansions. Before Kymanox, he worked for MedImmune, BioReliance, and Kraft Foods.
At MedImmune, Tim was responsible for cell culture manufacturing of clinical materials before transitioning to the team designing and starting up a state-of-the-art multi-product clinical facility. In this role, Tim led projects that were critical to start-up, including development of a preventive maintenance system and procedures, the changeover of production equipment and areas from the construction phase to production, and a facility-wide rust and rouge remediation.
Over the course of his career, Tim has been involved in the documentation efforts of clinical production, writing hundreds of SOPs, specifications, and production records. His increasing involvement in this and many other facets of cGMP production have been vital for the successful completion of the projects on which he has worked.
Tim graduated cum laude from Shenandoah University with a Bachelors of Science in Biology, and has both a Masters of Science in Biotechnology and a Masters of Business Administration with a Biotech focus from Johns Hopkins University. He can be reached at timothy.miller@kymanox.com.
Miguel Montalvo
Mr. Miguel Montalvo has over 24 years of experience in the areas of CGMP compliance, quality operations/systems and validation functions/responsibilities. He is the owner and President of Expert Validation Consulting, Inc., a firm specialized in focused and practical consulting for the pharmaceutical and OTC drug industry on CGMP compliance areas. Before forming EVC, Mr. Montalvo held positions of increasing responsibility in the areas of Validation, Technical Services, and Quality Operations in companies such as AAC Consulting Group, Inc., Millipore Corporation, Raytheon Engineers and Constructors, Mova Pharmaceutical Corp., Bristol-Myers Squibb and Baxter Healthcare Corporation. He has developed comprehensive and compliant quality and validation programs and systems for numerous companies and provided support, audits, and assessments for many existing operations. His extensive areas of expertise include development and implementation of quality functional procedures (QA/QC), internal and external CGMP audits including remediation efforts for companies under a consent decree, non-conformance evaluation and documentation, Quality Systems, handling of all kinds of investigations and deviations, validation maintenance, change control, CAPA, international GMP compliance, all types of validations, calibrations, Risk Management, and start-up manufacturing facilities.
He holds a BS in Chemical Engineering from Rensselaer Polytechnic Institute and an MBA. He has been a frequent speaker and has chaired hundreds of validation and quality related conferences around the world for such groups as PDA, PTi, CfPIE, IVT, Barnett International and the CTFA. His articles and papers have been published in the American Pharmaceutical Review and the Journal of Validation Technology. He is a member of the Journal of Validation Technology Editorial Advisory Board. Miguel can be reached by telephone at (407) 587-6540 and by e-mail at: mmontalvo@expertvalcon.com.
Jeff Morgan
Jeff Morgan, Principal Consultant, JWM Associates LLC, has over 30 years of combined clinical and research laboratory management and scientific experience. His expertise includes CLIA Compliance consulting services and Quality Systems (FDA QSR, ISO 9001 and ISO 13485) consulting and auditing. Jeff also provides consultation in the areas of GXP Facility Compliance, and management of technology transfer and scale-up, validation protocol development, and in-vitro diagnostics research and development assistance. He may be reached by e-mail at jm@jwmabio.com
Jacques Mourrain, Ph.D.
Jacques Mourrain, Ph.D., is the Director of Corporate Compliance at Genentech Inc. in South San Francisco, California. He can be reached via e-mail at mourrain@gene.com.
Patrick Murray
Pat Murray has over 20 years of experience in manufacturing and engineering. He holds both a Bachelor degree in Industrial Technology and a Master of Science in Technical Management from the University of Maryland. He is also a Certified Quality Engineer (CQE-ASQ). Pat is now a consultant specializing in process validation for pharmaceutical, medical device, and industrial companies. Visit his web site at www.linkedin.com/in/patmurray50.
Charlie Neal, Jr.
Charlie Neal, Jr. is a GMP consultant with NNE Pharmaplan. He has a Bachelor of Science degree in biomedical engineering from Louisiana Tech University. He has been involved with validation since 1980, having worked in the fine-chemical, pharmaceutical, biotech, and engineering industries. He has held positions in the fields of research, development, process engineering, manufacturing, validation, quality assurance and sales and marketing. Mr. Neal can be reached by e-mail at cnealjr@nc.rr.com or cnea@nnepharmaplan.com.
Joseph Neilly
Joseph Neilly, M.S. is a Research Investigator in Global Pharmaceutical and Analytical Sciences in Global Research and Development of Abbott Laboratories. He has been with Abbott for 23 years. He is the group leader for the microscopy and microanalysis group where he oversees scientists specializing in the fields of optical microscopy, electron microscopy, elemental analysis by energy dispersive x-ray spectroscopy, chemical analysis by vibrational spectroscopy and other specialized microscopy tools such as atomic force microscopy. He currently uses these microscopy and microanalysis tools for characterization of new APIs, drug formulations, extraneous matter investigations and supporting production investigations. His current interests lie in application of environmental SEM for studying API and formulations. He is active in the Pharmaceutical focused interest group of the Microscopy Society of America (MSA) and the Midwest Microscopy and Microanalysis Society (MMMS). He can be reached at joe.neilly@abbott.com.
Barbara A. Nollau
Ms. Nollau is a Director of Quality Services at Abbott Vascular, responsible for Validations, Reliability Engineering, Supplier Quality, Microbiology, and Document Management.
Prior to this, she was an Executive Consultant at Global Life Sciences Inc., responsible for providing professional services to the full spectrum of organizations within the life sciences industry. Before that, she held various quality and compliance-related leadership positions with Watson Pharmaceuticals, AstraZeneca, Alpharma (now Actavis), and MicroMedia Systems.
Ms. Nollau has 25 years of experience and increasing responsibility in the pharmaceutical and medical device industry, spanning the areas of Manufacturing, Quality Assurance/Compliance, and Information Services/Information Technology. She holds a BA in Communications from Cabrini College, a Certificate in Pharmaceutical Engineering from California State University, and has completed graduate work toward an M.Ed. at Penn State University. Ms. Nollau is an ASQ-certified Manager of Quality and Organizational Excellence, and is a member of PDA, and ISPE. She is a member of the GAMP Americas Steering Committee and is serving as a Commissioner on the ISPE Professional Certification Commission. She is a member of the Technology Advisory Board for LSIT, and of the Editorial Review Board of The Journal of Validation Technology and the Journal of GXP Compliance, and has published numerous papers and presented extensively on validation, 21 CFR Part 11, and related topics. Ms. Nollau can be reached via e-mail at barbara.nollau@av.abbott.com.
Brian K. Nunnally, Ph.D.
Brian K. Nunnally, Ph.D., is in charge of process validation for Wyeth in Sanford, North Carolina. His group is responsible for all process technical services and validation for the Sanford vaccines plant. Dr. Nunnally previously worked in Technical Operations and Product Supply (TO&PS) Regulatory Affairs where he was responsible for leading the Sanford site’s contributions to one of the biggest filings in pharmaceutical history. Prior to joining TO&PS Regulatory Affairs, Dr. Nunnally was the Associate Director for GMP Operations in Vaccine Analytical Development at Wyeth. The group he led was responsible for all reference standards, stability, GMP testing, and validation for the vaccine candidates Wyeth was developing. Dr. Nunnally has previously worked for Eli Lilly and Company. While at Lilly, he was responsible for leading a quality control laboratory devoted to new method development, method optimization, analytical testing for process validation, and analytical testing for manufacturing investigations.
Dr. Nunnally is a member of two United States Pharmacopeia (USP) 2005-2010 Expert Committees: Reference Standards and Biotechnology and Biologics: Vaccine and Virology. Dr. Nunnally received two Bachelor of Science degrees (1994) from South Carolina Honors College and University of South Carolina, Columbia. He earned his Ph.D. degree (1998) in chemistry from Duke University, Durham, North Carolina.
He is a co-author, with John McConnell, of the book Six Sigma in the Pharmaceutical Industry [2007, Taylor & Francis]. Dr. Nunnally has authored numerous publications in the fields of analytical chemistry, process excellence, and operations management and has given lectures on a variety of subjects. He is an assistant editor of the journal Analytical Letters and is a member of the Analytical Chemistry Division of the American Chemical Society.
James Oliver is a Principal Validation Engineer in the Validation Department at Baxter Healthcare Corporation, Baxter BioScience Division, Thousand Oaks, CA. He has a M.Eng in Chemical Engineering from University College London, England.
Janis V. Olson
Janis V. Olson (Halvorsen) worked for FDA for over 22 years in various positions including investigator and Director of Information Technology. She has a BS in Biology from Cornell University and a MS in Computer System Engineering from the University of Central Florida. She currently works as a consultant with EduQuest, Inc. assisting companies with complying with FDA regulations and understanding computer system development and validation.
Brandon J. Patterson
Brandon J. Patterson is a Sr. Process Engineer at Kymanox – a diversified company specializing in technical project management for the pharmaceutical, biotechnology and medical device industries. He has over 8 years of cGMP manufacturing experience as a validation engineer, equipment/process engineer and maintenance supervisor. Brandon has participated in major equipment installations, product launches, and a facility qualification.
Before starting at Kymanox, Brandon had various roles in a solid oral dose manufacturing plant supporting operations. As a validation engineer Brandon has experience in cleaning validation and equipment/facility/utility qualifications. He has had several experiences with FDA and other regulatory agency inspections. As an equipment engineer he supported the installation of a multi-million dollar form/fill/seal machine for the launch of a new product at the plant. Responsibilities included troubleshooting, continuous improvement, and training.
While at Kymanox, Brandon has experience as the lead engineering role for the qualification of an aseptic manufacturing facility, engineering support for the commercialization of a phase III drug, and engineering support for the commissioning and installation of a custom manufacturing skid.
Brandon has an engineering education background with a bachelor’s degree in Chemical Engineering from Purdue University. Brandon is member of the International Society of Pharmaceutical Engineering (ISPE). Brandon can be reached at brandon.patterson@kymanox.com.
Justin Pawlik
Justin Pawlik is vice-president of Midwest Operations at Kymanox, Highland Park, IL. Justin has over a decade of manufacturing and quality experience in the pharmaceutical industry as a quality manager, technical project manager, and operations manager. He can be reached at justin.pawlik@kymanox.com
Paul L. Pluta, Ph.D.
Paul Pluta, Ph.D., has more than 30 years of pharmaceutical industry experience and is a long-standing adjunct faculty member at the University of Illinois College of Pharmacy in Chicago. Pluta has coordinated the JVT “Benchmarking” column and was a valued member of the JVT Editorial Advisory Board for several years.
Additionally, Pluta was Validation Manager at Abbott Global Pharmaceutical Operations in North Chicago, Illinois, where he was responsible for validation projects and associated activities including manufacturing process validation, cleaning validation, packaging validation, and support systems qualification. Pluta has been involved in nearly all phases of pharmaceutical development and manufacturing, including R&D formulation and process development, dissolution, regulatory, stability, quality assurance, compliance, specifications, technical support, and validation/qualification. He has more than 30 years of pharmaceutical industry experience. Dr. Pluta’s experience as an adjunct faculty member at the University of Illinois College of Pharmacy in Chicago has included graduate student teaching, undergraduate teaching, and the student externship program. He has presented numerous academic lectures and scientific presentations at pharmaceutical industry meetings. He coordinates both the “Benchmarking’ and “Validation Learning Center” column in the Journal of Validation Technology. He is a member of AAPS, ISPE, and PDA.
Richard Poska
As director in Abbott's Global Pharmaceutical Regulatory Affairs, Richard Poska leads an exceptional team focusing on CMC small molecules. Richard earned his B.S. degree in Pharmacy from the University of Illinois College of Pharmacy and has worked with solid dosage forms at both Searle Laboratories and The Upjohn Company before joining Abbott. His 20 years of technical experience includes solid dosage form research, production troubleshooting, process improvement and support, harmonization of excipients and processing, application of statistics for manufacturing controls, Puerto Rico liaison and FDA inspection administrator. Richard chaired the SUPAC Equipment Equivalents Steering Committee for the International Society of Pharmaceutical Engineers (ISPE) which won the Vice-President’s National Performance Review “Hammer Award” for building a government that works better and costs less. Richard has chaired PhRMA's Technical Leadership Committee and served on the Drug Product Technical Committee. He also represented ISPE and PhRMA on the Drug Product Technical Committee of the Product Quality Research Institute. Richard can be contacted via email at richard.poska@abbott.com.
Yihong Qiu, Ph.D.
Yihong Qiu is a research fellow of the Volwiler Society and associate director of GPRA-CMC of Abbott Laboratories. Since joining Abbott in 1992, he has accumulated in-depth knowledge, skills and extensive experience in a broad range of product development areas. His expertise encompasses preformulation, biopharmaceutics, drug delivery, product design, formulation/process development, scale-up, optimization, operation and global regulatory registration for NCE’s, line-extension and marketed products. He also plays a key role in the product life cycle management, intellectual property strategy and development. His work has resulted in marketed IR and MR products, patented drug delivery technologies, IVIVC’s and biowaivers accepted by regulatory agencies of North America and EU.
Yihong is a fellow of American Association of Pharmaceutical Scientists (AAPS). His research interests include oral modified-release systems, dissolution, bioavailability, IVIVC, drug delivery and science-based regulation. He has more than 40 publications in journals and books, 30 patents granted or pending, and many conference presentations. He is the lead editor and contributor of a recent book, Developing Oral Dosage Forms: Pharmaceutical Theory and Practice. He contributes regularly to professional organizations and institutions, such as AAPS, CPA, CRS, Extension Services in Pharmacy @ UW, PQRI, the FDA, and universities by giving speeches, editing/refereeing publications, and organizing meetings. Dr. Qiu received a BS in Pharmacy, a MS. in Pharmaceutics from China Pharmaceutical University, and Ph.D. in Pharmaceutics from The University of Iowa.
Jackelyn Rodriguez has over 27 years experience in all facets of Quality Assurance and Regulatory Compliance and is currently the President of Monarch Quality Systems Solutions. Ms. Rodriquez has served as a member of the Board of Examiners for the Malcolm Baldridge National Quality Award program. She has published numerous validation and compliance-related articles and has been a global industry speaker and presenter on several compliance topics. Ms. Rodriguez can be contacted by e-mail at jackelynr@comcast.net
Malcolm Ross
Malcolm Ross is a Pharmacist and Chemist and the CEO of Generapharm Training and Consultancy based in Basel, Switzerland. He started his pharmaceutical career as an academic and has worked in the Pharmaceutical Industry since 1978. After holding senior positions in leading generics companies in several different countries over a 25 year period he has established himself as a regular trainer on matters of quality assurance, pharmaceutical analysis, project management and formulation development. Malcolm can be contacted at m.ross@generapharm.eu.
Rizwan Sharnez
Dr. Rizwan Sharnez is principal engineer at Amgen, Colorado. He has 15 years experience in the pharmaceutical industry. Mr. Sharnez can be contacted at rsharnez@amgen.com.
Alan J. Smith, Ph.D.
Alan Smith is an independent consultant to the pharmaceutical industry specializing in quality management and the application of CGMPs to the industry. He was formerly the Corporate Director of Quality Affairs for the Whitehall Laboratories Division of American Home Products Corporation (now Wyeth) following a career with the Ayerst Division, where he successively managed analytical development, stability programs, site QA and aspects of corporate QA. His earlier career included working in the nuclear field for the UK Royal Naval Scientific Service and, upon emigrating to the US, working for the Rohm & Haas Company in ion exchange technology and acting as the company’s technical FDA liaison. His consulting work has included working on projects for many large and small pharmaceutical companies both within the US and internationally and serving on the Board of Directors for Halsey Pharmaceuticals from 1996 to 2004.
Alan received his B.Sc and Ph.D. degrees in chemistry from the University of London (UK), his post graduate and post doctorate work consisting of determining the structure of the ionic species of ruthenium in its various valency states. As part of his work with the Royal Naval Scientific Service, he underwent intensive training at the UK Atomic Energy Authority. Upon reaching the US, he studied business administration at the Wharton School of the University of Pennsylvania.
Alan is a member of the American Chemical Society and the American Society for Quality. He has been the Chairman, Director and/or speaker at many domestic and international conferences and seminars. He has also been the member of several industrial association committees including the PMA (now PhRMA) Committee on Stability & Expiration Dating and the ASTM Committee on Quality Systems.
In addition to serving on the Editorial Advisory Board of Journal of GXP Compliance and co-editing its regular column “GXP Talk,” Alan serves on the Editorial Advisory Board of Pharmaceutical Technology. In 1998, he received the WorldPharm award for his service to the pharmaceutical industry.
Alan resides in Newport, Rhode Island, and can be contacted by phone at 401-846-5418 and e-mail at ajsconsri@aol.com.
Patricia L. Smith, Ph.D
Patricia L. Smith, Ph.D., is a statistician and process improvement specialist with experience in academics, industry, and consulting. Dr. Smith developed an interest in bulk sampling while working for Shell Oil Company, where she furnished statistical support and training for research and development, manufacturing, and refining. Currently, Dr. Smith provides training and consulting in the sampling of solids, liquids, and gases for industry and government, as well as in the Six Sigma methodology. Her book A Primer for Sampling Solids, Liquids, and Gases is a practical guide for those in the field as well as an introduction for the theoretician. She may be reached at astat00@aol.com.
Robert Smith
Robert Smith is an application technical lead responsible for quality systems software development at Abbott Vascular. Prior to this, he was Sr. Director, Engineering at Symantec Corporation, where he was responsible for developing enterprise client, host and server based corporate security products as well as the Symantec and Norton Live Update offering. Robert has 25 years of software development experience including VC start-ups funded by The Mayfield Fund, Granite Capital and Wasatch Venture Fund, and holds CISSP and PMP credentials. Robert can be reached at robert.smithii@av.abbott.com.
Scott Sutton, Ph.D.
Dr. Sutton earned his Masters and Ph.D. in Microbiology from the University of
Rochester (NY). After a NIH postdoctoral fellowship he worked for Bausch and
Lomb until 1994 when he went to Alcon Laboratories, and in 2004, accepted a
position with Vectech Pharmaceutical Consultants. He has worked with the USP
Microbiology Committee of Experts since 1993, serving as vice-chair since
2000. Dr. Sutton also operates an information source on the Internet, The
Microbiology Network (www.microbiol.org) which provides services to
microbiology-related user’s groups and supports the PMFList, a microbiology
Email list (www.microbiol.org/pmflist) and the PSDG Email list (pharmaceutical
stability topics) (www.microbiol.org.psdglist). Dr. Sutton is a popular consultant
in contamination control, microbiology, aseptic manufacturing and rapid
microbiology methods.
Dr. Sutton can be reached at scott.sutton@microbiol.org, which more
information at www.microbiol.org or www.linkedin.com/in/scottvwsutton.
Andrew Vogt
Andrew Vogt is a research chemist in the Global Pharmaceutical Research and Development at Abbott Laboratoris. He has been there for more than nine years. His expertise is in the utilization of an array of microscopy and spectroscopy techniques (including optical microscopy, scanning electron microscopy, atomic force microscopy, infrared spectroscopy, x-ray photoelectron spectroscopy) to understand and support formulation research and development, as well as characterization of active ingredients to support investigational new drug applications. He also supports manufacturing and product complaint entities throughout the company by way of characterization of extraneous matter and suspected counterfeited product. He can be reached at andrew.d.vogt@abbott.com.
Peter Weichel
Peter Weichel holds an M.S. degree from University of Southern Denmark. He is IPMA certified as a Project Management Associate and works as a Project Manager in the pharmaceutical industry. Peter can be reached at peterweichel@hotmail.com.
Gordon Welty, Ph.D.
Gordon Welty, Ph.D. has been designing, developing, facilitating, evaluating, and managing technical and regulatory training programs in the healthcare and pharmaceutical industries for more than 20 years. Contact Gordon at gwelty@wright.edu.
Chris Wernimont
Mr. Chris Wernimont, P.E., is principal of Project Technologies, Inc., a company dedicated to enhancing major capital project delivery and execution in the pharmaceutical and biotech industries.
Mr. Wernimont experience includes sterile antibiotic manufacturing management and technical services, as well as, process engineering in bulk API manufacturing. He can be reached at cwernimont@project-technology.com or 317-498-4375.
Trudy Yin
Trudy Yin is president/consultant of TY Consulting Services. She provides global quality, regulatory compliance, and validation support for pharmaceutical, biotechnology and medical device clients. She is also an adviser to the Food and Pharmaceutical division of CMA Testing and Certification Laboratories, HK. Trudy can be reached by email at trudyyin@cmatcl.com or trudy.yin@gmail.com <mailto:trudy.yin@gmail.com>
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