Our faculty is composed of industry experts from around the world. We provide expert training by explaining the concepts, demonstrating the techniques in actual laboratory settings and verifying the understanding of those concepts. Some team members include:
John Lindsay - Executive Director and Founder
(click here to view Mr. Lindsay's CV)
John has been a consultant to the pharmaceutical industry for over 12 years. Prior to that, he had 27 years experience in industry in roles of Quality Control (Labs), Quality Assurance and Manufacturing, with companies including Genentech, Burroughs Welcome and Marion Merrell Dow. He holds a Master’s Degree in Microbiology from Kansas University Medical School, is a Registered Specialist Microbiologist by the American College of Microbiologists, and is the Former Chair of the National Registry of Microbiologists (six years).
For eight years, he coordinated and led the PDA’s two-week Aseptic Processing course at the PDA Training and Research Institute in Baltimore, Maryland. John was a member of the PQRI Committee to provide input to the FDA’s Guidance to Industry on Aseptic Processing published in September, 2004. In 2007, John founded the Aseptic Training Institute, LLC, a facility dedicated to providing hands-on training to members of the pharmaceutical and biotechnology industries. The Institute currently has two training facilities - one in Clayton, North Carolina, and the other in Cardiff, Wales.
Richard A. Matthews - Founder and Chairman - Filtration Technology, Inc.
Richard A. Matthews is Founder and Chairman of Filtration Technology, Inc., Greensboro, North Carolina, USA, a multi-location licensed cleanroom general contractor for over 1,000 turnkey Cleanroom projects and a manufacturer and distributor of industrial filtration equipment.
Mr. Matthews is the Founding Chairman (1993-2005) of the International Organization for Standardization (ISO) Technical Committee ISO/TC209 “Cleanrooms and Associated Controlled Environments” whose responsibility is to write global cleanroom standards. This activity involves 41 nations.
Active in the contamination control field since 1957, he is a Past President of the Institute of Environmental Sciences & Technology (IEST) and former Vice-Chairman of the Standing Committee of the International Confederation of Contamination Control Societies (ICCCS). He is a member of AAMI, IEST, ISPE and PDA.
He is also the former President of Micron Video International, Inc., a producer and distributor of professional competency-based multi-media specialty training programs for personnel who work in controlled environments.
He is the author of numerous articles and technical presentations as well as a keynote speaker on filtration and contamination control issues.
Sean Kerrigan- Sr. cGMP Consultant - General Econopak, Inc.
Sean is a Sr. cGMP Consultant for General Econopak, Inc., a U.S. based manufacturer of sterilization wrapping solutions and pre-sterilized cleanroom materials. He has over 14 years’ experience in the industry, identifying and providing solutions for pharmaceutical and biotechnology clients with needs related to process improvements in parts/ equipment preparation, sterility maintenance, particulate reduction and aseptic technique.
As a subject matter expert on Good Manufacturing Practices for component prep, maintaining sterility from the autoclave to the production area, and facilitating aseptic technique, he has been an instructor with the Aseptic Training Institute (ATI) since 2008, conducting trainings at their Clayton, NC and University of Cardiff, Wales facilities. Sean joined the PDA faculty in 2013. He holds a Bachelor’s degree in General Sciences, with a focus in Biology, from Rutgers University.
Carol Lampe - Consultant
Carol Lampe is currently an independent consultant. She retired from Baxter Healthcare’s Corporate Sterility Assurance Group, where she worked for over 30 years and was a subject matter expert on aseptic processing. She was the co‑chair for TR#62 on “Recommended Practices for Manual Aseptic Processes”, which was issued in 2013, and is the trainer for a PDA course on the subject. She served on the PDA task force for the original and recently revised (2013) TR#22 on process simulation testing of aseptically produced products. She was a member of the PQRI Committee that evaluated the FDA draft guidance on aseptic processing She was on the PDA training team, who along with the FDA, provided training and interpretation of the 2004 FDA guidance to industry on aseptic processing. She currently is a member of the training cadre for course work relating to fundamentals of aseptic processing, cleanroom fundamentals, support sterilization, and cleanroom behavior.
David Crance- Asia Pacific Life Sciences Manager - Particle Measuring System
Mr. David Crance is the Asia Pacific Life Sciences Manager for Particle Measuring Systems and has been in the Life Sciences business for over 30 years. He has lectured for pharmaceutical societies and organizations throughout the USA and Asia on environmental monitoring systems and their cGMP regulations. He has been an Instructor at the Parenteral Drug Association (PDA) headquarters in Bethesda, Maryland for over nine years.
Mr. Crance has been involved in the design and implementation of almost 500 environmental monitoring systems. In his role as Asia Pacific Life Sciences Manager, Mr. Crance works with leading engineering firms and manufacturers in the designing of monitoring systems in new construction and renovation.
Anthony J. Cannon- Head, Drug Product Manufacturing Technology - Samsung Biologics, Yeonsu-gu, Incheon, Korea
Tony is currently the Head of Drug Product Manufacturing Technology responsible for all technical support of sterile drug product manufacturing operations. He has held various positions throughout his career in Drug Product development and manufacturing with a focus on formulation and process development of both liquid and lyophilized parenterals, final container development and optimization, medical devices and drug delivery. He has over 18 years’ in the industry with experience in biologics (plasma products, proteins, peptides, liposomes, vaccines; viral and bacterial), small molecules, nanocrystals, medical devices, reagents, nutriceuticals and cytotoxics, focused on lyophilization development. He has also presented on the fundamental of lyophilization, formulation, process development, thermal characterization, finished product analysis, and scale up and tech transfer at various conferences, seminars and pharmaceutical and biotech companies in North America, Europe and Asia.
Chad Wilkey - Sr. Product Manager - bioMerieux, Inc.
Chad Wilkey is the Sr. Product Manager for Pharmaceutical Culture Media at bioMerieux, Inc. He is responsible for formulating and implementing strategies for different brands based on distinct technologies and market segments to match customer and market needs. He has been with bioMerieux, Inc. since 2000. He holds a Bachelor of Science degree in Biology from the University of Illinois. He is an active member of the PDA and has served as a speaker at the PDA Global Conference on Pharmaceutical Microbiology and the American Medical Device Manufacturers Annual Meeting.
Doreen Stickney - Principal QA Specialist- AstraZeneca, LP
Doreen is a Principal Quality Assurance Specialist – Aseptic Operations within the AstraZeneca Supply Side Organization. She has primary QA responsibility for Aseptic Operations including quality investigations, CAPA program, internal auditing, environmental trending, SOP review and approval and change control.
As a member of the AstraZeneca Global Aseptic Forum Panel, she provides her expertise to review and discuss Regulatory Agency visits to the sites, as well as making recommendations based on current industry issues and changes among regulatory guidance’s i.e. FDA, Annex I etc.
She develops all training courses for gowning, aseptic behavior in a clean room environment, aseptic technique and cleaning and disinfection within in an isolator system. Introduction to Aseptic training has been adopted globally for AstraZeneca Supply Sites.
She has been an instructor with the Aseptic Training Institute (ATI) since 2008, conducting training at the Clayton, NC facility.
She has a BS degree in Biology and over 25 years experience in the pharmaceutical and biotech industry.