The Role of Mixed Reality in Quality 4.0

February 11 — 6 to 9 PM

Thermo Fisher Scientific, 168 Third Ave. Waltham MA 02451

Join us for an exciting February dinner meeting with presentation by Jeremiah Genest, Head of Digital Quality in Thermo Fisher Scientific’s Viral Vector Services unit.

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

Augmented Reality and Virtual Reality are more than just a science fiction dream, with the market expected to exceed $50 billion by 2024. The technology promises that workers will have more information about the task at hand, which makes them more efficient and productive. In this session we will explore several opportunities the technologies present and provide a glimpse on how Thermo Fisher Scientific is working with key technology providers to implement on the pharmaceutical manufacturing floor. Bring your resumes or open job descriptions!

CLICK HERE TO REGISTER

Jeremiah Genest

I am a quality professional with 18 years of experience in the Pharmaceutical industry located in Boston, MA.

I currently hold the Certified Manager of Quality/Operational Excellence (CMQ/OE) and the Pharmaceutical GMP Professional Certification (CPGP) certifications from the American Society of Quality.

I am passionate on topics related to change management, knowledge management, risk management, quality culture, data integrity and the future of quality.

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

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.

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