Roy Kinkaid is an independent quality consultant (25+ years of experience) with an extensive background in the implementation of various quality management systems – Six Sigma, Baldridge, Continuous Improvement, ISO and the Carnegie Mellon Capability Maturity Model. Roy has a degree in management/ statistics from Philadelphia University, certification in Six Sigma, and is a member of ASQ, the SEI, and IEEE Software Society. He has practical process improvement experience in manufacturing, service, software, and electronic commerce industries, helping companies to achieve six sigma quality performance levels. In addition Roy has hands on experience with change management, coaching and the facilitation skills necessary to implement a quality program. He has extensive experience working in Europe, the UK and Asia.
Ray Lotfi is an independent consultant with over 20 years of operation experience with expertise in medical device and consumer product industries on Quality, Regulatory, R&D, Logistic, and Manufacturing issues. Ray has been the project leader on multiple projects, chaired FMEA teams and served on CAPA panels. He has authored Quality System Manuals, Standard Operation Procedures, and Manufacturing Operation Procedures. He has led commissioning projects on the installation, operational and performance qualification of medical devices in aseptic environments. Ray has Master of Science in Engineering Management for the Milwaukee School of Engineering and Bachelor of Science in Mechanical Engineering from the University of Wisconsin.
Tom Reed is the Director of Quality and Operator Qualifications Platforms at Henkels & McCoy (Blue Bell, PA). He holds a CMQ/OE and MBA & MS from The University of Michigan. He is known by his passion for making improvements with critical thinking; i.e., Toyota Kata and enterprising A3-Reports, and in leveraging the company strategic planning processes. His enjoys his Project Management PMI PMBoK world with ISO9001:2015 quality standard of compliance at minimum in mind and Lean Six Sigma in his back pocket. Prior to working for Henkels & McCoy he was employed for fifteen years in automotive electronics manufacturing and supply with Ford Motor and Visteon Corporation.
Jay Armstrong is the Director of the Project Management Office of the Temple University Health System. He holds a B.A. in Bio-anthropology, Summa cum Laude, an MSc. in Biotechnology Engineering (both, University of Pennsylvania), an M.S.E. in Technology Management (Wharton/University of Pennsylvania), and an MSc. in Biotechnology (Johns Hopkins). Mr. Armstrong has more than 20 years of experience in the Pharmaceutical industry in the areas of R&D, Pre-clinical Drug discovery, Lean Six Sigma, Decision analysis, Innovation, Operations management, Strategy development, Tactical planning, and Analytics and is the holder of 10 US and international patents for his experimental work with Sirolimus in organ transplantation. He is a Six Sigma Master Black Belt, Six Sigma Black Belt (ASQ, University of Notre Dame), CMQ/OE (ASQ) and is a graduate of the Project Management and Decision Analysis programs at Stanford University and the Lean Academy at MIT.
Lou is a corporate executive with over twenty five years of experience in all aspects of cGMP facility, equipment and systems cGMP compliance validation projects and management. His experience has included both domestic and EU cGMPs. Areas of concentration have included bulk processes, containment, computer systems, fermentation (microbial and mammalian), blood products, aseptic processes and sterilization (ETO, E-Beam, Cobalt, steam). Consulted on the subjects of commissioning, validation and cGMP compliance to clients worldwide, including Europe, South Africa, South America, Japan, China and the Middle East. Extensive inspection and remediation experience with the FDA, locally and internationally, as well as with the EU.
Lou addresses, manages, coordinates and remediates FDA and MHRA findings. A frequent lecturer on topics of validation, commissioning, regulatory initiatives and compliance to various industry organizations. He is an experienced QA Director in establishing specifications criteria OOS and product release. He is also an experienced regulatory affairs director in establishing necessary programs for regulatory submissions, CAPA management, complaint handling and adverse event reporting. Experienced manager of departments and people. He was a corporate director for validation responsible for project management. Established standard practices for validation worldwide. A recognized quality compliance and industry leader. Lou holds PMI PMP certification as well as ASQ CQA and CQE certifications.
Stewart is an ASQ-certified Six Sigma Black Belt and Manager of Quality/Organizational Excellence, with a BA from UCLA and MBA from Loyola Marymount, and certifications in finance and accounting (CPA, CMA & CGMA). He’s led Kaizen and Value Stream Design events with 10-50 participants that usual led to him launching and managing several process improvement projects. H teaches students how to create and manage customer-focused projects that deliver significant reductions in lead time, cycle time and/or resources, with hard savings and soft benefits. He volunteers time as ASQ Philadelphia section’s Treasurer.
Curt Gendler an ASQ Certified Software Quality Engineer and a PMI Certified Project Manager (PMP) is a Quality Senior Engineer at AstraZeneca Biologics at the Frederick Manufacturing Center in Maryland, USA. Curt brings real life experience to his class for those who not only want to be certified but want to go beyond the boundaries of the CSQE Primer and learn through actual experience. He has worked in the Quality arena for over 25 years, and over 35 years in the Computer industry. He has hands-on CSV experience and oversight of the Computer System Validation program (along with his group at AstraZeneca Biologics) and Management experience throughout the medical device and pharmaceutical industry.
Curt spearheads a CSV/A (assurance) training program incorporating the soon to be released FDA Guidance on Computer System Assurance (targeted to replace the FDA Computer Software Validation Guidance. Recognized as a Quality Champion, he has introduced a leaner improved approach to Software Validation incorporating Critical Assurance based thinking and risk-based validation.
Paul Staudt is the Worldwide Manager of Supplier Quality Management at Ethicon Inc, a Division of Johnson & Johnson (Somerville, NJ). Paul earned a BSE in Chemical and Biomolecular Engineering from the University of Pennsylvania and an MS in Regulatory Affairs and Quality Assurance from the Temple University School of Pharmacy. He is a Certified Quality Auditor (ASQ), Certified Quality Engineer (ASQ), a Certified Professional in Supply Management (ISM), and a Certified SS Green Belt. Paul is a goal-oriented motivator with great success in leading & elevating the performance of diverse, multifunctional teams. He has 20 years of progressive experience within the Pharmaceutical, Medical Device, Consumer Healthcare, and Elastomer Industries.