Computer Systems Validation (CSV) & Data Integrity Compliance Congress

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Implement Programs that are Compliant, Smart and Progress with Today’s Evolving Technology

December 11, 2017 - December 13, 2017

Washington, D.C., United States

Recent FDA Warning Letters Highlight CSV & DI Deficiencies

 

In 2017, FDA has issued many Warning Letters emphasizing CSV non-compliance. These serious findings include; having interrupted, missing, deleted and lost data; inadequate records for risk analysis; failure to exercise appropriate controls; failure to validate computer software; failure to establish validation procedures; manipulation and deletion of audit trails; and many more. The time has never been more critical to evaluate and ensure your organization has top-notch compliant procedures. KENX is pleased to announce that our comprehensive CSV& DI Congress is headed to Washington D.C. and showcases the protocols, methodology and actions necessary to avoid regulatory action.

 

Choose from Over 30 Tutorials Addressing Today’s Top Challenges

 

Computer Systems Validation

  • Conduct a CSV Audit Enterprise-Wide and Develop a Master Plan
  • Perform Risk Assessments on Complex Systems
  • Understand Documentation Requirements for Validation
  • Confirm Accurate Processing, Control and Reporting of Electronic Records
  • Develop an Effective CSV Corrective Action and Preventive Action (CAPA) Program
  • Audit and Validate Paper, Electronic and Hybrid Systems
  • Streamline Processes with Innovative E-Validation Solutions
  • Write IQ/OQ/PQ Procedures, User Requirements and Test Scripts for New Systems
  • Learn Best Practices for Change and Configuration Management
  • Qualify Cloud Infrastructures & Mobile Devices
  • Understand How to Validate Excel™ Spreadsheets

 

Data Integrity Compliance

  • Develop, Implement and Maintain Data Integrity Protocols Enterprise-Wide
  • Learn the Methodology and Techniques Used to Identify Inaccuracies
  • Conduct an Audit Enterprise-Wide
  • Ensure the Reliability and Completeness of Analytical Data
  • Identify and Investigate Root Causes of Integrity Lapses
  • Cybersecurity Risk Management Implementation and Continued Verification
  • Perform a Risk Assessment for Deficiencies
  • Understand Requirements and How to Handle Audit Trails

 

Personnel in the Following Environments Should Attend:

  • Validation
  • QA/QC
  • Engineering
  • IT
  • Quality Control
  • Manufacturing Management
  • Laboratory Management
  • Regulatory Affairs

 

This event is also appropriate to business development and sales managers that offer innovative solutions for quality departments, validation departments, data collection and statistics.

Agenda

  • 1:15
    Chairperson’s Opening Remarks
  • 1:30
    FDA’s Data Integrity Guidance, Trends and Warning Letters
    Sarah Barkow, Team Lead, Lead Consumer Safety Officer, U.S. Food and Drug Administration
  • 2:00
    Impact of Human Factors on Data Integrity Validation
    Paul Labas, Capital Validation Lead, Data Integrity CoE, Global Pharma Company
  • 2:30
    Data Integrity, it all Matters, but what Really Matters NOW?
    Jay Chenier, Process Owner, Global Computer Validation, GlaxoSmithKline
  • 3:30
    Cybersecurity, Data Integrity & Validation – Addressing Malicious Threats to the Life Science Industry
    Erik Muegge, M.S., Manager Operations Quality, Abbott Laboratories – Diagnostics Division
  • 4:00
    CSV & DI Risk Management Tools and Techniques
    Byron Mattingly, Ph.D., Software Division Chair, American Society for Quality
  • 4:30
    The Regulatory Interrelationship Between CSV, Part 11 and Data Integrity
    Ivan Soto, Director Client Engagement & Product Strategy, ValGenesis
  • 07:30 – 08:15
    Select Between Knowledge Exchange Sessions (1-3)
  • (1)
    Manage Vendors and Contractors on CSV & DI Compliance
    Robert J. Wherry, MSc, MS, CQA, CPGP, CPIP, Head – R&D Data Systems QA & Compliance, Shire
  • (2)
    Audit Your Audit Trails
    John English, HCCP, Computer System Validation and Regulatory Compliance
  • (3)
    Change Control and Configuration Management
    Eric Collier, Assistant Director, and Automation, Commissioning Agents, Inc.
  • 08:30 – 12:00
    Select Between Knowledge Exchange Workshops (A-C)
  • (A)
    Ensure Data Integrity in the Face of the Modern Threat Landscape
    Paul Drapeau, Principal Security Researcher, Carbon Black
  • (B)
    Develop, Implement and Maintain a CSV Master Plan (VMP) Enterprise-Wide – Don’t Fall Victim to One of the Classic Blunders
    J Loren Smith, Senior Manager, Global Compliance & Ethics, Computer Systems/Data Integrity, BioMarin Pharmaceutical, Inc.
  • (C)
    Develop a Data Integrity Compliance Master Plan and Learn the Techniques Used to Identify Inaccuracies
    Erik Muegge, M.S., Manager Operations Quality, Abbott Laboratories – Diagnostics Division
  • 13:15 – 14:45
    Select Between Knowledge Exchange Sessions (4-6)
  • (4)
    Key Components for System Qualification – IQ/OQ/PQ Procedures, Documentation and Test Scripts
    Charles Cotter, Senior Validation Consultant, Sanofi
  • (5)
    Software Design Studies, Validation, Protocols and Reports
    Jay Waterbury, Associate Director, Global Compliance & Ethics, Computer Systems/Data Integrity, BioMarin Pharmaceutical, Inc.
  • (6)
    Identify and Handle the Root Cause of a Data Integrity Breach
    Ivan Soto, Director Client Engagement & Product Strategy, ValGenesis
  • 15:15 – 16:45
    Select Between Knowledge Exchange Sessions (7-9)
  • (7)
    Qualifying Cloud Infrastructures & Mobile Devices
    John English, HCCP, Computer System Validation and Regulatory Compliance
  • (8)
    CSV Master Class – Cybersecurity, Automation and Lean Principles
    Valarie King-Bailey, CEO, OnShore Technology Group, Inc.
  • (9)
    Preparing for and Performing a Data Integrity Audit
    Robert J. Wherry, MSc, MS, CQA, CPGP, CPIP, Head – R&D Data Systems QA & Compliance, Shire
  • 07:30 – 08:15
    Select Between Knowledge Exchange Sessions (10-12)
  • (10)
    Develop a Sustainable IT Risk Management Procedure
    John Adams, Jr., Computer Systems Validation Lead, Spark Therapeutics, Inc.
  • (11)
    Maintaining Data and Metadata Integrity for Records Retention Workflows
    Chris Wubbolt, Principal Consultant, QACV Consulting, LLC
  • (12)
    Perform a 21 CFR Part 11 Gap Assessment – So, You Want to Know About It?
    Charles Cotter, Senior Validation Consultant, Sanofi
  • 08:30 – 10:00
    Select Between Knowledge Exchange Sessions (13-15)
  • (13)
    Handling of CSV Non-Conformances
    Chris Wubbolt, Principal Consultant, QACV Consulting, LLC
  • (14)
    An Effective Roadmap for CSV Project Management
    Eric Collier, Assistant Director, IT and Automation, Commissioning Agents, Inc.
  • (15)
    Understand and Prevent Behavioral Non-Compliance
    Jay Chenier, Process Owner, Global Computer Validation, GlaxoSmithKline
  • 10:30 – 12:00
    Select Between Knowledge Exchange Sessions (16-18)
  • (16)
    Implement a Validation Process of Automated Manufacturing Software
    Orlando López, E-Compliance and E-records Integrity SME
  • (17)
    Perform Risk Assessments on Complex Computer Systems
    Byron Mattingly, Ph.D., Software Division Chair, American Society for Quality
  • (18)
    Data Governance in the Analytical Laboratory – What to Do When Things Go Wrong
    Robert Migliore, IT Validation, Celgene Corporation
  • 1:00 – 2:30
    Select Between Knowledge Exchange Sessions (19-21)
  • (19)
    Implement Validation Protocols for Excel™ Spreadsheets
    John Adams, Jr., Computer Systems Validation Lead, Spark Therapeutics, Inc.
  • (20)
    Qualify Cloud Infrastructures & Mobile Devices
    CSV & DI Audits and Master Plans in the Analytical Lab
  • (21)
    Prepare for and Handle Investigators on Data Integrity Compliance
    William Honeck, Vice President, West Coast Operations, VTI Life Sciences, Inc.
  • 3:00 – 4:30
    Select Between Knowledge Exchange Sessions (22-23)
  • (22)
    Audit and Validate Paper, Electronic and Hybrid Systems – So You Think You’re an Auditor
    J Loren Smith, Senior Manager, Global Compliance & Ethics, Computer Systems/Data Integrity, BioMarin Pharmaceutical, Inc.
  • (23)
    Manage the Quality, Accuracy and Governance of Big Data
    Orlando López, E-Compliance and E-records Integrity SME

Faculty

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

    Mr. Adams is a seasoned Computer Systems Validation professional within 17 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.
  • Sarah Barkow, Ph.D., Lead Consumer Safety Officer, FDA/CDER/OC/OMQ

    Drug manufacturing focused chemist with expertise including data integrity, regulatory compliance, and medical gas policy and research experience, including chemistry and immunoassay development. Specialties: FDA, policy, data integrity, medical gas, protein chemistry, CGMP, data analysis, analytical chemistry, instrument maintenance, statistical analysis, DOE, enzyme kinetics, organization, communication, immunoassay development, mentoring, cross-functional teams.
  • Jay Chenier, Process Owner, Global Computer Validation, GlaxoSmithKline

    Mr. Chenier is a leader in the Global Computer Validation organization currently on secondment with R&D automating data integrity controls for the next generation of analytical platforms. This includes developing a GxP lifecycle for use of Agile software development practices. He has 26 years of experience including leading the GSK implementation of Annex 11. More recently, he led adoption of the MHRA, FDA (draft) and WHO data integrity guidance documents into policy, procedures, communications and training.
  • Eric Collier, Assistant Director IT and Automation, Commissioning Agents, Inc.

    Mr. Collier is an IT professional with more than 25 years of experience in CSV and the Software Development Lifecycle. His first introduction to computer system validation occurred in the early 1990’s as a software engineer working on Department of Defense (DOD) projects. These projects introduced him to the software engineering standards from which many of our current CSV best practices are derived.
  • Charles Cotter, Senior Validation Consultant, Sanofi

    Mr. Cotter is a graduate of Worcester Polytechnic Institute with a B.S. in Analytical Chemistry and an experienced resource with over twenty-seven years of experience in pharmaceutical and biopharmaceutical environments. He has held positions in different areas (chemistry, compliance, validation and consulting) and his areas of interest in validation include: utilities, facilities, analytical methods, equipment/automated processes, 21 CFR Part 11, requalification and cleaning validations.
  • Paul Drapeau, Principal Security Researcher, Carbon Black

    Paul Drapeau is a Principal Researcher on Carbon Black’s threat research team focused on improving endpoint defenses against attackers and malware. Prior to joining Carbon Black, Paul managed IT security for a global pharmaceutical firm. He has spoken at DEFCON, Infosec World and other security and pharmaceutical industry conferences.
  • John English, HCCP, Computer System Validation and Regulatory Compliance

    John English, HCCP, MCS, MPS has been described as “the consultant your consultants call when they have a problem.” He has over 25 years of experience across the FDA regulated industries in computer system and software validation, as well as “Part 11,” the Cloud and Data Integrity issues. The companies he has worked with on-site have been in the US, Canada, Puerto Rico and the EU.
  • Paul Labas, Senior Validation Consultant, NTT DATA

    Paul Labas offers close to 20 years of experience in all aspects of computerized systems compliance, computerized systems validation, IT quality assurance, and data Integrity. His diverse experience includes high-risk projects such as establishment of organizational compliance frameworks, efforts executed under consent decrees, and validation of systems in use by more than 100,000 people worldwide.
  • Orlando López, E-Compliance and E-records Integrity SME

    Orlando had held several technical and management eCompliance positions in different pharmaceutical and medical device companies. Orlando has thorough knowledge of e-records integrity regulations and guidelines (21 CFR Part 11, Annex 11, MHRA, WHO, PIC/C, CFDA, USFDA, EU OMLC). He has experience evaluating, designing/redesigning business rules, processes, definitions and quality expectations to ensure e-records integrity in a scalable and efficient manner.
  • Byron Mattingly, Ph.D., Software Division Chair, American Society for Quality

    Dr. Byron Mattingly is currently the Chair of the Software Division of the American Society for Quality. He is a senior level systems and software quality engineering manager with over 17 years' experience in pharma, healthcare IT and medical devices. Dr. Mattingly graduated with a bachelor's from Princeton University, a PhD and Master's from Stony Brook, an MPhil from University of St Andrews (Scotland), and an MBA and a Master's in Public Health from the University of Massachusetts at Amherst.
  • Robert Migliore, IT Validation, Celgene Corporation

    Robert (Bob) Migliore is an experienced team leader with over twenty years of experience of engineering, validation, and quality in the pharmaceutical industry; supporting new and existing systems, new product introduction (sterile, topical, and OSD) in both small and large molecule. Through strategic thinking, he has success in steering and managing computer validation approaches in the pharmaceutical industries.
  • Erik Muegge, M.S., Manager Operations Quality, Abbott Laboratories – Diagnostics Division

    Erik Muegge’s experience is focused on FDA and related regulated environments for pharmaceuticals, consumer products, and medical devices. His specific areas of work include Quality Systems, operations, outsourcing, process re-engineering, project management, product development life cycle (R&D through Launch) and validation. Erik has; led efforts in several PPC (Production and Process Controls) areas; harmonized validation activities globally across seven sites; audited quality systems of strategic partners; been recognized as a global SME resulting in three industry awards.
  • Enow Nsemanyu, CSV Consultant, ProPharma Group

    Enow Nsemanyu is an SME on CSV and Compliance with over 12 years of experience in biotechnology industry. My experience covers a wide range of areas including CSV, deviation, CAPA and change control. Enow also has hands-on experience in vaccine fill finish process that includes filling machines, isolators and capping machines.
  • J Loren Smith, Senior Manager, Global Compliance & Ethics, Computer Systems/Data Integrity, BioMarin Pharmaceutical, Inc.

    Loren has over 28 years of experience specializing in computer systems compliance (from the IT, QA, and Compliance perspectives) in medical device, biotech, pharmaceutical, analytical instrumentation, and software companies. Loren has also been an instructor at University of California, Berkeley, since 2006, teaching computer systems compliance to students in clinical research.
  • Ivan Soto, Director Client Engagement & Product Strategy, ValGenesis Systems

    Ivan Soto is an experienced leader with over 25 years of experience in quality and all areas of validation including; process/product validation, facilities validation, CSV and 21 CFR Part 11, analytical method validation, equipment/automated processes and cleaning validation. Mr. Soto is currently Director Client Engagement & Product Strategy, ValGenesis Systems.
  • Jay Waterbury, Associate Director, Global Compliance & Ethics, Computer Systems / Data Integrity, BioMarin Pharmaceutical, Inc.

    Jay Waterbury joined BioMarin in 2015 as the initial member of its Global Compliance & Ethics group to establish a center of excellence focusing on computer systems and data integrity. Jay has 20+ years of experience specializing in computer systems compliance in a variety biotech and pharmaceutical companies ranging from mid-sized to global.
  • Robert J. Wherry, MSc, MS, CQA, CPGP, CPIP, Head – R&D Data Systems QA & Compliance, Shire

    Mr. Wherry has thirty-four (34) years of international pharmaceutical, biotechnology and medical device experience with expertise in Computerized System Validation, data integrity, quality systems, process validation, aseptic processing, regulatory operations and eCTD submissions. He has served as an industry consultant, performing data integrity audits around the globe at multiple companies. Bob currently is the Head of R&D Data Systems Quality Assurance and Compliance for Shire.
  • Chris Wubbolt, Principal Consultant, QACV Consulting, LLC

    Chris Wubbolt is a Certified Six Sigma Black Belt, has a Masters Degree in Quality Assurance and Regulatory Affairs and a BS in Physics and Computer Engineering. Mr. Wubbolt was the previous President of both the New England Region Chapter Society of Quality Assurance (NERCSQA) and the Mid-Atlantic Region Society of Quality Assurance (MARSQA), and is currently the chairperson of the MARSQA computer validation committee.

Sponsors

  • Platinum Hospitality Suite Sponsor:

    Award Winning Technology for Validation and Verification Processes
    Website: http://onshoretech.com/
  • Silver Sponsors:

    Global Leader in Paperless Validation
    Website: http://www.valgenesis.com/
  • Inspiring Operational Excellence through Best-in-Class CQV Processes
    Website: http://validation.org/
  • Assuring quality and audit readiness, combining smart e-validation platform, lean process & decades of GxP expertise
    Website: http://www.qspace.live/
  • RAQA: Combined, Defined, and Online. The Leader in Education RA and QA Professionals for 50 Years.
    Website: https://www.temple.edu/pharmacy_qara/
  • Global leader of measurement and precision instruments for industry, laboratories and retail
    Website: http://www.mt.com

Partners

Venue

Details

Start:
December 11, 2017
End:
December 13, 2017
Event Category:

Venue

The Dupont Circle Hotel
1500 New Hampshire Avenue NW
Washington, D.C., DC 20036 United States
+ Google Map
Phone:
+1 202 483 6000
Website:
www.doylecollection.com/dupontcircle.com

Pricing & Registration

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