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 Continuous Improvement and Quality at Henkels & McCoy (Blue Bell, PA). 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 ISO9001:2008 quality standard of compliance at minimum in mind and Lean Six Sigma in his back pocket. Prior to working for Henkels & McCoy he attended the University of Michigan and Lehigh University. He was employed for fifteen years in automotive electronics manufacturing and supply with Ford Motor and Visteon Corp. Mr. Reed volunteers time toward ASQ Philadelphia Chapter and toward the startup of a local Mid-Atlantic chapter of the Lean Construction Institute.
He holds certification as an ASQ Six Sigma Black Belt and advanced degrees from Stanford, University of Pennsylvania, Johns Hopkins in fields such as Biotechnology, Management, Biomedical Technology. He holds certificates in Project Management, and Decision/Risk Management. He has led workshops in employee coaching, designing and fundamentals with led to eight Kaizen events, and five discovery events. He was the leader in launching of the process workshops for clinical trials, and developed and led a clinical trials E-2-E work-stream which identified 10 clinical process area improvements. He is responsible for leading of five R&D process-improvement teams in delivering major cycle time, cost, and resource reductions of up to 80%, leading to $11M savings.
Lou is currently a Senior Project Manager at Johnson & Johnson. He 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. He addressed, managed, coordinated and remediated 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.
President and Founder of Spartacus Project Management Group, LLC. Superior Project Management services to businesses in the Philadelphia metro area. Specializing in serving small businesses and entrepreneurs who need expert Project Management skills on an “as needed” basis. Clark holds a Master of Business Administration (with distinction) from the Keller Graduate School of Management, Ft. Washington PA and a Bachelor of Sciences in Technical Management with Project Management concentration Magna Cum Laude from DeVry University, Ft. Washington PA. He is an ASQ Certified Six Sigma Green Belt and trainer and a member in good standing of PMI.