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NETWORK INFRASTRUCTURE & CLOUD QUALIFICATION

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Implementation and Qualification of a Risk-Based, Compliant and Secure Environment

June 25 @ 7:30 AM - June 26 @ 5:00 PM

San Francisco, United States

Network Infrastructure & Cloud Qualification

 

FDA Warning Letters are on the rise within network infrastructures and the cloud. The time has never been greater to ensure these environments are qualified, controlled and Data Integrity compliant. Investments on compliance breaches are at a record high so best-in-class project management should be top priority of your organization. KENX is proud to present an event gives you the tools you need to project manage you and your organization through the development, implementation, and maintenance of a program that impresses FDA investigators. Topics to be discussed include:

 

  • Understand the Regulations and Benefits
  • Maintain Effective Change Management Processes
  • Cost Management while Excelling in Quality
  • Documentation Requirements for Qualification
  • Continued Network/Cloud Verification
  • Maintaining the Qualified State
  • Proactive Data Integrity Compliance
  • Monitor Cloud Environments for GDPR Compliance
  • IAAS, PAAS, and SAAS Processes and Controls
  • Assessment Checklist of Compliant Infrastructures
  • IQ/OQ/PQ of Infrastructure components
  • Service Provider and Vendor Audits
  • Cybersecurity – Address Malicious Threats
  • What to Do When Things Go Wrong – Disaster Recovery
  • Develop a Risk Management Approach
  • Configuration Management for Off-The-Shelf Software
  • Operating Systems and Servers

Personnel in the Following Environments Should Attend:

  • Information Technology/Systems
  • Quality
  • Validation
  • Database and System Administrators
  • Regulatory Affairs
  • Document Management
  • Engineering

 

This event is also appropriate to business development and sales managers that offer innovative solutions for IT, network infrastructures, the cloud and other software services.

 

Click Here to View the Agenda-At-A-Glance

Agenda

  • 7:30AM
    Registration and Continental Breakfast
  • 8:00AM
    Chairperson’s Opening Remarks
  • 8:15AM
    Cloud Computing Regulations and Requirements with the FDA and EU
    Oisín Curran, CEO, Odyssey VC | Stephen Long, Senior Network Engineer, Odyssey VC
  • 9:00AM
    Technology Changes: What Does the Future Look Like
    Raul Soto, MSc, CQE, Senior Principal Engineer, Johnson & Johnson Vision Care
  • 9:45AM
    Networking Refreshment Break
  • 10:15AM
    Guide to Data Center Facility Qualification
    Stephen Long, Senior Network Engineer, Odyssey VC | Oisín Curran, CEO, Odyssey VC
  • 11:00AM
    USFDA’s Draft & Final DI Guidance – A Clue to Their Current Thinking on DI
    Chinmoy Roy, Data Integrity and CSV SME, Consultant
  • 11:30AM
    Top Five Tips Using Cloud Computing in a Regulated Environment
    John Hannon, PE, CPIP, CBCP, Global Principal for Automation and IT, CAI
  • 12:00PM
    Select Between Lunch and Learn Sessions (1-2)
  • (1)
    Globalize Your Technology: Computer, Process, and Equipment Validation
    John Patterson, Sr. Consultant, QACV BioPharma Group
  • (2)
    Avoid the Pitfalls in Network Qualification
    Cynthia E Pleach, Quality Assurance Manager, Information Technology, Sage Therapeutics
  • GENERAL SESSIONS
  • 1:15PM
    Change Control and the Cloud – The Vendors Got My Back Right?
    John Adams, Jr., Computer Systems Validation Lead, Spark Therapeutics, Inc.
  • 2:00PM
    Everything is a Service: Choose the Best Fit
    Cynthia E Pleach, Quality Assurance Manager, Information Technology, Sage Therapeutics
  • 3:00PM
    Network Refreshment Break
  • 3:30PM
    Risks of SaaS in Life Science and How to Mitigate Them
    Terri Mead, President, Solutions2Projects, LLC
  • 4:15PM
    Manage a Global/Enterprise Infrastructures in a Regulated World
    Lelia Scott, Executive Director, Global Quality Systems, Charles River
  • 5:00PM
    Welcome Cocktail Reception and Temple Scholarship Award
  • 7:00AM
    Coffee and Lite Breakfast
  • 7:30AM – 8:15AM
    Select Between Knowledge Exchange Sessions (3-4)
  • (3)
    Data Integrity Issues in the Cloud
    Chinmoy Roy, Data Integrity and CSV SME, Consultant
  • (4)
    Case Study – Implementation of a Cloud-Based, Virtual MES Infrastructure
    John Hannon, PE, CPIP, CBCP, Global Principal for Automation and IT, CAI
  • 8:30AM – 10:00AM
    Select Between Knowledge Exchange Sessions (5-6)
  • (5)
    Validation Strategies for Data Migration
    Raul Soto, MSc, CQE, Senior Principal Engineer, Johnson & Johnson Vision Care
  • (6)
    Build a Blue Print to Qualify IaaS and PaaS
    Steve Thompson, Director Computer Quality Assurance, Science 37
  • 10:00AM
    Networking Refreshment Break
  • 10:30AM – 12:00PM
    Select Between Knowledge Exchange Sessions (7-8)
  • (7)
    Benefits of Data Flow/Process Mapping for IT Infrastructure
    Lelia Scott, Executive Director, Global Quality Systems, Charles River | Jennifer Siegrist-Skapura, Global Computer Systems Validation QA Specialist, Charles River
  • (8)
    SaaS Validation Best Practices: Requirement through Retirement
    Steve Thompson, Director Computer Quality Assurance, Science 37
  • 12:00PM
    Select Between Lunch and Learn Sessions (9-10)
  • (9)
    Validation and Management of SaaS Hosted Electronic Signature Solutions
    Jennifer Siegrist-Skapura, Global Computer Systems Validation QA Specialist, Charles River
  • (10)
    Efficient Ways to Perform Cyber Security in Order to Maintain Data Integrity & Infrastructure Qualification
    John Patterson, Sr. Consultant, QACV BioPharma Group
  • 1:15PM – 2:45PM
    Select Between Knowledge Exchange Sessions (11-12)
  • (11)
    Validation Mobile App
    Raul Soto, MSc, CQE, Senior Principal Engineer, Johnson & Johnson Vision Care
  • (12)
    Auditing Cloud (SaaS) and External Hosting Vendors
    Terri Mead, President, Solutions2Projects, LLC
  • 2:45PM
    Networking Refreshment Break
  • 3:15PM Closing Session
    Developing a 21st Century Global Disaster Recovery Plan
    John Adams, Computer Systems Validation Lead, Spark Therapeutics, Inc.
  • 5:00PM
    Close of Conference

Faculty

  • ADVISORY COMMITTEE

  • Terri Mead, President, Solutions2Projects, LLC

    Terri Hanson Mead is President of Solutions2Projects, LLC, a consulting company that provides IT strategy, IT compliance, SaaS/software/IT vendor audit, and digital health advisory services to Biotech, Med Device, Diagnostic, and Digital Health companies. She is an expert witness focused on failed enterprise IT projects and SaaS in life sciences. Terri is an angel investor actively investing in and advising digital health and early stage female-led startups. She is an advisor with Springboard and Women’s Startup Lab and former EIR with Tech Futures Group. Terri is also a podcaster (Piloting Your Life), speaker, blogger, and in her spare time, flies helicopters around the San Francisco Bay Area.
  • Lelia Scott, Executive Director, Global Quality Systems, Charles River

    Ms. Scott is the Executive Director of the Global Quality Systems team at Charles River Laboratories. She has 15 years of progressively challenging QA experience within the pharmaceutical industry and 7 years in analytical lab sciences. She specializes in data integrity compliance, global process adoption, implementation of enterprise-wide quality systems, computer system validation, laboratory systems, relationship building in cross-functional teams and development of innovative solutions to expedite business processes using electronic systems in compliance with global pharmaceutical regulations. Ms. Scott holds a BSc in Chemistry from the University of Western Ontario and an MBA in Pharmaceutical Management from Fairleigh Dickinson University.
  • FACULTY

  • John Adams, Computer Systems Validation Lead, Spark Therapeutics, Inc.

    Mr. Adams is a seasoned Computer Systems Validation professional within 19 years of experience working in an FDA regulated environment. Using a risk based approach, Mr. Adams has validated a wide range of computer system ranging from ERP, LIMS, Record/Document Management, Environmental Monitoring Systems (EMS), Distributed Control Systems (DCS) for lyophilization processes, and blood banking software.
  • Oisín Curran, CEO, Odyssey VC

  • John Hannon, PE, CPIP, CBCP, Global Principal for Automation and IT, CAI

    John Hannon, PE, CPIP, CBCP is an Executive Consultant and Business Principal for Automation and IT at Commissioning Agents. With over 29 years in the pharmaceutical, IT, and process automation fields, he has been instrumental in starting up cutting-edge biotech facilities for companies such as Shire, Elanco, Amgen, Genentech, Pfizer, and Cook. He has managed multi-million dollar projects and project teams across the US and Europe, and is responsible for delivering hundreds of high-profile, mission-critical projects for data center, biotech, pharmaceutical, and medical device customers. Currently he is responsible for the development of automation, MES, and other IT system projects within the international client base. With a demonstrated knowledge of quality assurance and regulatory compliance across the pharmaceutical industry, Mr. Hannon has led national and international seminars with ISPE, contributed to several publications such as Pharmaceutical Technology, and has led speaking venues related to risk-based approaches to smarter integrated system delivery compliant to the FDA, USDA, and EU regulatory agencies. He is an active and sought-after consultant for complex IT and automation problems in the pharmaceutical industry. Mr. Hannon holds a Bachelor of Science in Electrical Engineering from Georgia Tech, has completed studies at Harvard Business School, is a Certified Pharmaceutical Industry Professional and holds Professional Engineering certification in the state of North Carolina. Most recently he has worked with pharmacetical clients to resolve data integrity related regulatory citings.
  • Stephen Long, Senior Network Engineer, Odyssey VC

    Stephen is a Senior Network Engineer with 17+ years’ experience in security, design, implementation and maintaining of infrastructure in a variety of different environments including Datacenter and Cloud.
  • Terri Mead, President, Solutions2Projects, LLC

    Terri Hanson Mead is President of Solutions2Projects, LLC, a consulting company that provides IT strategy, IT compliance, SaaS/software/IT vendor audit, and digital health advisory services to Biotech, Med Device, Diagnostic, and Digital Health companies. She is an expert witness focused on failed enterprise IT projects and SaaS in life sciences. Terri is an angel investor actively investing in and advising digital health and early stage female-led startups. She is an advisor with Springboard and Women’s Startup Lab and former EIR with Tech Futures Group. Terri is also a podcaster (Piloting Your Life), speaker, blogger, and in her spare time, flies helicopters around the San Francisco Bay Area.
  • John Patterson, Sr. Consultant, QACV BioPharma Group

    John Patterson is a Sr. Consultant at QACV BioPharma Group (previously known as QACV Consulting) and supports a diverse group of bio-pharmaceutical clients providing technical, quality assurance, validation and GxP data integrity services. John possesses over 30 years bio-pharmaceutical industry experience at MSD/Merck & Co and EMD Serono where he distinguished himself in various technical roles including engineering, technical operations, manufacturing, quality assurance and information technology. He has significant experience preparing, managing and responding to GMP and GCP regulatory inspections and most recently has been focused on establishing information security and data protection programs intended to further strengthen GxP data integrity. Mr. Patterson maintains active involvement with multiple ISPE and industry SIGs and has been a contributing author on technical articles in leading industry publications including Pharmaceutical Engineering, the Institute of Validation Technology (IVT), and the ISPE Baseline Guide on Oral Solid Dosage Forms. John earned his B.S. in Agricultural Engineering from the University of Wisconsin-Madison and a Master of Science in Engineering (M.S.E.) from Purdue University and resides with his family in Doylestown Pennsylvania.
  • Cynthia Pleach, Manager, Quality Assurance IT, Sage Therapeutics

    Cynthia has over 15 years experiences in the Life Science Industry with roles in both Quality and Information Technology. She has experience in validating applications for Regulatory, Quality, Clinical, Pharmacovigilance, Sales and ERP. She has validated on premise, single tenant and multi- tenant applications. She is an experienced auditor and public speaker.
  • Chinmoy Roy, Data Integrity and CSV SME, Consultant

    Chinmoy Roy is an experienced biopharmaceutical consultant with subject matter expertise in CSV, Data Integrity, CFR 21 Part 11, Annex 11 and manufacturing process automation systems. He is a member of ISPE’s Data Integrity Special Interest Group (S.I.G). His presentations blend his field experience to highlight the intricacies of implementing regulations. Chinmoy has a bachelor’s degree in Electrical Engineer and a Master’s degree in Computer Science.
  • Lelia Scott, Executive Director, Global Quality Systems, Charles River

    Ms. Scott is the Executive Director of the Global Quality Systems team at Charles River Laboratories. She has 15 years of progressively challenging QA experience within the pharmaceutical industry and 7 years in analytical lab sciences. She specializes in data integrity compliance, global process adoption, implementation of enterprise-wide quality systems, computer system validation, laboratory systems, relationship building in cross-functional teams and development of innovative solutions to expedite business processes using electronic systems in compliance with global pharmaceutical regulations. Ms. Scott holds a BSc in Chemistry from the University of Western Ontario and an MBA in Pharmaceutical Management from Fairleigh Dickinson University.
  • Jennifer Siegrist-Skapura, Global Computer Systems Validation QA Specialist, Charles River

    Ms. Skapura is a Specialist with the Global Computer Validation QA department at Charles River Laboratories. She has 15 years of experience within the pharmaceutical industry including a strong formulations background. She specializes in global regulations impacting GLP and GMP systems and data workflows, global computer system validation, risk management and electronic signature implementation and validation. She holds a Bachelor in Biological Science and Organizational Leadership and an MBA from Wright State University.
  • Raul Soto, MSc, CQE, Senior Principal Engineer, Johnson & Johnson Vision Care

    Raul Soto is a Senior Principal Software Engineer at Johnson & Johnson Vision Care (JJVC), focused on Computerized Systems Validation and Software Quality Engineering. Mr. Soto has over 20 years of experience in validation, process engineering, industrial automation, and software quality; and has held positions of increasing responsibilities in the medical devices, biotechnology, pharmaceutical, and consumer electronics industries. Raul has led multiple global and site projects in the United States, Europe and China. As an invited speaker he has lectured on computer systems validation, data integrity, statistics, PLC/SCADA automation, and quality/compliance issues at various conferences in the United States and Europe. Raul has an MS degree in Biotechnology with emphasis on Biomedical Engineering, and a BS degree in Mechanical Engineering. He is also an ASQ Certified Quality Engineer (CQE).
  • Steve Thompson, Director Computer Quality Assurance, Science 37

    Mr. Thompson over 20 years’ experience in life science working in Quality Assurance and Information Technology functions that span GxP regulations, both domestic and international. Steve has worked for start-ups and large multinational companies that includes biotechnology, pharmaceutical, medical device, and cloud-based Software-as-a-Service (SaaS) solution providers. He is a published author, was certified as a PDA Systems Auditor in 2003, and received a Bachelor of Science, Computer Information Systems, in 1986.

Sponsors

  • SILVER





  • AVQC, Array Validation Quality & Compliance, Inc. is a Multinational Life Sciences Global Compliance Consulting Firm with 25 + years experience delivering Technical Writing and Validation Services in the Pharmaceutical, Medical Device, Biotechnology and Food Industries.
  • QACV offers comprehensive quality assurance, compliance, and computer validation consulting services to meet your regulatory needs. We provide professional consulting services to FDA regulated life science industries and use proven methodologies to achieve sustainable compliance for your organization.
    Website: http://www.qacvconsulting.com/
  • Global Leader in Paperless Validation
    Website: http://www.valgenesis.com
  • Inspiring Operational Excellence through Best-in-Class CQV Processes
    Website: http://www.validation.org

Partners

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