WEBINAR TOPIC

Update from the FDA and Industry-CSV Team on Non-Product CSV. 
Join this dynamic session to hear updates from the FDA & Industry Non-Product CSV team on their recommendations for streamlining non-product software validation. This powerful presentation contains 3 parts:

  • Recap from the FDA on Draft Guidance

  • Successful Case Studies from Compliance Group – how these game changing process improvements are being implemented at client sites

  • Automating Non-Product CSV – Siemens Polarion – A Siemens Success Story 

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SPEAKERS

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Jason Spiegler 
Senior Director of Strategic Initiatives,
Life Sciences Practice, Siemens PLM

Jason has 20+ years of experience in various Quality, Business Development, and Sales Management roles. His experience includes service as Head of Quality and FDA Correspondent, responsible for implementing all elements of the Quality System and executing their quality strategy with all external partners. Jason has been with Siemens PLM for 12+ years, and is responsible for leading many of their strategic initiatives with customers and external partners within the Life Sciences practice.

 
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Khaled Moussally 
Head of Quality,
Compliance Group

Khaled is Compliance Group’s Head of Quality Practice. He has over 23 years of experience as a Quality Compliance leader in Life Sciences industry. Under the leadership of Khaled, Compliance Group has rolled out FDA CSV Team’s recommendations to various clients with game changing results. Khaled is known for establishing Validation Center of Excellence programs and Validation Streamlining / Automation initiatives. His engagements are focused on enabling his clients to achieve transformation through process innovation, automation and service oriented quality delivery.

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Francisco Vicenty 
Quality Program Manager,
US Food and Drug Administration

Cisco is an experienced Quality Program Manager in FDA with a demonstrated history of working in the government administration industry. Program Manager for FDA’s “Case for Quality” initiative, working in collaboration with medical device stakeholders to drive a focus on quality and continuous improvement in the medical device industry and innovation in regulatory oversight. Prior to this, Cisco has served as the Branch Chief - Respiratory, Ears/Nose/Throat, General Hospital, and Ophthalmic Devices.

 
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Lou Poirier 
IT Manager,
Medtronic

An IT management professional with experience in fast-paced pharmaceutical and medical device industries. Catalyst in implementing positive change, integrating new systems, and meeting regulatory compliance for quality systems. Expansive network of key industry contacts at vendors, suppliers, and manufacturers with knowledge of state-of-the-art software and hardware for CSV solutions. Deployed SDLC Methodology for Boston Scientific and Covidien and have automated SDLC in 3 companies over the last 15 years.