In 1980 Mr. Tafreshi began his professional carrier as a machinist by day and a mechanical engineering student at night. In the early days of rapid advancement of technology where the traditional electro-mechanical designs where being replaced by processors, Mr. Tafreshi entered the machine design arena. In his 10 years as a designer he recorded number of manufacturing machinery and assembly line design advancements employing the use of CNC, EDM, CAD, CAM, and Control Processors.
In 1992 Mr. Tafreshi began applying his manufacturing systems expertise to help the Pharmaceutical, Biotech and Medical Device Industry meet the regulatory compliance challenges. Among his accomplishments in this area is the pioneering of automating the system specification and test protocol document generation. He served the industry as an independent consultant in validation, regulatory compliance and training. In 1997 Mr. Tafreshi founded Intelitec Corporation in Irvine, California to continue serving the regulated industry which from 1998 included the Medical Gas industry. His vision and deep understanding of the regulatory requirements has positioned Intelitec Corporation as the North American leader in providing process validation and advance process controls implementation services to the Medical Gas industry.
Mr. Tafreshi is currently the president of Intelitec Corporation and heads the newly created branch of Business Systems Design and Management. Mr. Tafreshi has been a member with PDA since 1994 and serving as the president of Southern California Chapter since 2006.
John is the Manager of Validation and Quality Systems in R&D at Allergan for the last 4 years. Prior to Allergan, he was with B. Braun Medical for 13 years where he held Quality Control management positions. He has been an active board member with the local chapter since 2006.
Bill Nichols is sole owner of W J Nichols Electric Co. He retired from Parexel Int. in 2001 where he was a Senior Project Manager for Validation focusing on validation of computer systems. Prior to that he worked at Fluor Daniels as a senior Electrical Engineer where he managed the electrical design of pharmaceutical projects and at MIT’s Draper Labs where he managed prototype development of military related projects. He has been an active Southern Cal. PDA board member since 2008.
Randy is Business Development Manager with Kyoto America and works directly with companies offering engineering turnkey consulting, project management, automation solutions and packaging equipment to improve operating efficiencies in the pharmaceutical, medical device and nutritional supplements industries. Prior to joining Kyoto America Randy hold the same position with Gima Advance Technology Inc.
Mujtaba Ali has over 25 years of experience in Pharmaceutical / Biotech industry in the Operations, Validation and Quality oversight functions. Currently, he is working at Genentech Oceanside as a Director in the Quality Assurance Group providing oversight for Quality Engineering Validation, Change Control and Document Control areas. Prior to this assignment, he was the Director of Corporate Engineering for Amylin Pharmaceuticals and was an integral part of the team that developed and delivered the Amylin Ohio Manufacturing Complex. He has also served on the ISPE SD Chapter Board.
Ruchika is President of Global Biopharm Regulations a small disadvantaged business. Global Biopharm Regulations helps with registration and quality compliance aspects of biologics on behalf of small to midsize firms and the department of health and human services. Prior to setting up her consulting practice in 2001, she was responsible for registration and compliance with Baxter Healthcare, Chiron Vaccines with increasing levels of responsibility. She holds a Masters is Microbiology, and Certifications as a Lead Auditor for three Quality Standards through RAB QSA. Ruchika has been a member of PDA since 2000 and a volunteer with PDA board since 2008
Tony Steinberg, Sr. Director of Validation with Quality Compliance Partners, Inc. has over twenty two years of experience in the pharmaceutical, biopharmaceutical, medical device and healthcare industries. Tony is a very highly experienced professional with expertise in validation, quality assurance, project management, project controls, project budgeting, and training. His experience includes management of large validation projects, developing validation programs, writing validation master plans, development and execution of IQ/OQ/PQ protocols, protocol final reports/summaries and SOP preparation for Small Molecule, Solid Dosage, API, and Biologic manufacturers. Tony holds a B.S. in Quality Assurance from the Almeda University, and has held several management-level validation positions, most recently as Sr. Manager of Validation for a San-Diego based pharmaceutical company with several commercial products.
Brian Underhill is a Principal and founding member of BioSPEQ, Inc., a consulting firm with a project management approach to Quality Engineering, Quality Systems and Process Excellence in FDA-regulated industries. Brian holds a Masters in Science and a Masters in Business Administration.
Bonnie Ward is the President & CEO of Quality Compliance Partners, Inc., a quality and regulatory compliance consulting firm providing quality systems, quality assurance, audit, validation/qualification, training and regulatory support services. Bonnie Ward has over 25 years experience in the life science, high-tech and financial industries with both private and public companies. Prior to her current company she was the Vice President of Business Development at a Life Science validation and high-tech consulting firm. Bonnie began her career as a CPA and auditor with Deloitte. Bonnie is an active member of PDA and other industry and local organizations. Bonnie received a Bachelor of Science degree in Accounting and Information Systems from the University of Wisconsin-Madison, and a Master of Science degree from University of Colorado – Denver.