ASQ Boston Section

Boston, MA

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November 1, 2019 By ASQ Admin

November 18, 2019 Dinner Presentation

Tune Up Your CAPA Verification, Validation and Closure Processes!

November 18 — 6 to 9 PM
The Conference Center at Waltham Woods
860 Winter St, Waltham MA 02451

Join us for an exciting November Dinner meeting and presentation featuring Ken Peterson, globally recognized Quality Management Systems and CAPA consultant and MasterControl Partner.

Check-in & networking start 5:30, dinner 6, program about 6:45-8:20

Arriving at a workable corrective solution is only one component of an effective corrective and preventive action (CAPA) for companies that manufacture products with oversight regulations. Too often CAPA owners and managers don’t understand the separate nature of verification and validation and how they orchestrate the effectiveness checking process. They are not the same thing! What are the elements of each and how do they work both independently and together? Do you need to do both? “How long do you need to conduct the effectiveness check?” and “Can you close the CAPA before it is finished?” are just a few questions that make completing this component of the CAPA process difficult.

This presentation will examine both pre- and post-corrective actions and how to get the most out of your effectiveness checks in both reliability and efficiency. Bring your CAPA work instructions and questions and compare them to the best practices of the U.S. Food and Drug Administration (FDA) and other outstanding companies as we discuss effectiveness checks and closing CAPAs using a risk-based model. Solid pharma and medical device manufacturing examples will be discussed.

Bring your resumes or open job descriptions!

CLICK HERE TO REGISTER

Ken Peterson

Globally recognized Quality Management Systems & CAPA consultant; MasterControl Partner

Ken Peterson is a quality industry leader with expertise in both the life sciences and engineering. He has more than 30 years of experience in consulting and organizational change, quality management, and product development, and has trained hundreds of companies in leadership, innovation, compliance and CAPA systems. Peterson frequently travels across the United States and internationally, educating audiences about best practices in CAPA.

He has served as chairman of the board of directors for Intermountain Biomedical Association (IBA) and on the board of advisors for the Utah Technology Council (UTC). Peterson works closely with the FDA and businesses to drive growth and build lasting partnerships.

Most recently, he is an executive with Touchstone Enterprises, an education and consulting firm specializing in compliance and process management. Before leading Touchstone, Peterson played an important role at MasterControl as director of quality solutions, where his responsibilities included enhancing the company’s quality management system software offering by incorporating best practices for CAPA management. He is currently working on two new books; Innovations for life sciences and Performance Management in a Technical Environment.

Earlier in his career, he founded and served as the CEO at PathWise, an education and consulting firm specializing in compliance and process management. While there, he was involved in customer service, product development, marketing, delivery, quality systems (specifically CAPA and risk management), sales systems and policy changes, and successfully solved hundreds of quality problems from high-impact CAPA investigations to implementing better quality management systems. Prior to his 15-year tenure at PathWise, Peterson worked with Pfizer, where he gained a rich understanding of both the pharmaceutical and medical device industries.

Peterson graduated from Brigham Young University in 1981, where he was one of the founding members of the entrepreneurship program. He speaks annually for such organizations as the Association for the Advancement of Medical Instrumentation (AAMI), the Parenteral Drug Association (PDA), the American Society for Quality (ASQ), Barnett International, The Executive Committee (TEC) and other industry forums.


August 27, 2019 By ASQ Admin

ASQ Transformation

ASQ has undertaken a fundamental restructuring (not to quite everyone’s unalloyed delight, to be sure.)  Watch this space for news about new Directors/Regions layout, fiscal relationships, organization by Communities, expanded MyASQ and much more, especially as relates to this and neighboring Sections.

Results of the newest elections: coming soon.

August 27, 2019 By ASQ Admin

September 10, 2019 Dinner Presentation

Advances and Continuing Challenges in Manufacturing Process Control

September 10 — 6 to 9 PM
Gillette World Shaving Headquarters
1 Gillette Park Boston, MA 02127

Join us for a special September Dinner meeting as we host three distinguished experts in manufacturing for a round table discussing Advances in Process Control Strategies, use of sensors and on-line quality systems and the future of manufacturing among other discussion topics.

Panelists include:

Alberto Villalobos
Alberto Villalobos is the Quality Assurance Manager for Procter and Gamble Grooming Business in the Americas.

His responsibilities include the quality of the shaving razors manufactured in North America and Latin America that are exported to more than 120 countries and territories. Mr. Villalobos is also leading Digital Quality and other initiatives for the Grooming business globally.

Mr. Villalobos started his career in Procter and Gamble at the Gillette plant in Mexico City as a Quality Engineer and moved to the World Shaving Headquarters in South Boston where he has worked for the past 18 years.

Mr. Villalobos studied Chemical Engineering and complemented his education with a master’s degree in Quality Engineering from Iberoamericana University in Mexico City.

Ari Pihlajavesi
Ari Pihlajavesi is founder and CEO of Predisys, Inc., a Quality Control and Analytics Software company with global reach and offices in Europe and in the USA.

Under Mr. Pihlajavesi’s leadership, Predisys has grown from a local Finland based startup to a leading global software provider in a number of industries, such as Semiconductors, Electronics and Automotive. As he founded Predisys in 1996 as a young entrepreneur, his responsibilities varied from sales to product and business development. Today he is in charge of building a winning team, leading Predisys product strategy and engaging in strategic market development initiatives.

Mr. Pihlajavesi was born in Helsinki, Finland in 1967 and moved to the United States with his family in 2010 to open Predisys business operations for the Americas. Prior to founding Predisys, he worked as a Quality Engineer in the rapidly growing Finnish mobile phone industry of the 90’s. He holds a Master of Science degree in mechanical engineering from the Helsinki University of Technology.

Adam Sybrowsky
Adam Sybrowsky is General Business Manager / Manufacturing at MasterControl.

Mr. Sybrowsky has over 10 years of project management experience within the product and quality management spheres of the life sciences and other regulated sectors. As a general business manager at MasterControl, he has been instrumental in all phases of the creation of the company’s new manufacturing software solution, from planning and development to beta testing and launch. In his current role, Sybrowsky works closely with C-level stakeholders and quality engineers to demonstrate how digitized solutions can help manufacturers improve quality while also reducing production errors and delays while obtaining gaining greater operational efficiencies.

He is Project Management Professional (PMP) certified and has a wealth of experience leading business projects with multimillion-dollar portfolios. Mr. Sybrowsky has consistently assisted clients in increasing productivity and efficiency by helping them implement quality and project management principles and planning. He holds a bachelor’s degree in Russian with a minor in business management from the University of Utah.


Check-in and networking start at 5:30 pm. Dinner and the program from 6:00 pm to 8:00 pm.

Bring your resumes or open job descriptions!

CLICK HERE TO REGISTER

March 9, 2019 By Chair

BOSCON APRIL 2, 2019

CLICK HERE TO REGISTER

March 9, 2019 By Chair

BOSCON APRIL 1, 2019

CLICK HERE TO REGISTER

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