ASQ Pittsburgh Meeting May 2017



Process Validation : A Risk-Based Approach


Speaker: Jim Gianoutsos

Date: Tuesday, May 9, 2017

Start Time:  6:00 PM to 8:30 PM

6:00-6:30 – Registration and Social

6:30-7:00 – Dinner

7:00-8:30 – Presentation

Cost: $25 Dinner
          $10 Program only
          $10 Webinar Program
Location:  Sigmas Conference Center : 1717 Babcock Blvd. Pittsburgh, PA 15209
register now 195
Register is required:  Call ESWP, 412-261-4300 (hours 7:00am - 4:00pm)
                                         Sign up by Wednesday, May 3, 2017, 4:30pm  for Dinner only
Registration REQUIRED
Re-Certification Units (RU): Certificate for 0.3 RU's will be provided to ASQ Members attending the dinner program




Process validation activities start with a solid foundation of an established risk management program.  As such, it is often difficult to determine what the validation requirements should be to ensure a compliant process with FDA, ISO, and other regulatory agencies.  This presentation will focus on the basics of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities and how it ties into a risk management program (i.e. ISO 14971:2012).  It will also touch on the Master Validation Plan (MVP) expectations and sample sizes associated with the products’ risk analysis.




About the Speaker:

jim gianoutsos Jim Gianoutsos, Manager of Quality Assurance & Regulatory Affairs, has a diverse background in the medical device industry that includes experience in the design, pre-market approval, manufacturing, distribution and post-market surveillance of Class I, II, and III devices.  Prior to joining Circadiance, Jim acted as the Quality Assurance Manager for Cohera Medical, Inc., a leading innovator and developer of absorbable surgical adhesives and sealants.  Jim’s professional history includes experience with medical devices in a variety of clinical applications including but not limited to infant jaundice management, neonatal and non-neonatal respiratory care, infant incubation, sleep therapy, management of respiratory insufficiency, surgical adhesive for internal use, and surgical sealant for prevention of gastrointestinal leaks.  Jim has extensive experience in establishing and maintaining quality management systems in accordance with FDA, ISO, cGMP, MDD, CMDCAS requirements and standards and has helped develop and submit multiple regulatory files including Premarket Approval (PMA), 510(k), Design Dossiers, and Technical Files.  Jim holds a Bachelor of Science degree in Operations Management as well as Master of Business Administration with a concentration in Operations and Strategy from the University of Pittsburgh – Katz Graduate School of Business.


Process Validation : A Risk-Based Approach


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