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COMPUTER SYSTEMS VALIDATION &DATA INTEGRITY COMPLIANCE CONGRESS

COMMISSIONING, QUALIFICATION & VALIDATION UNIVERSITY

GOLD SPONSORS

Validation Solutions

15:00

15:30

Afternoon Refreshment Break

17:15 DIT Dublin Institute of Technology Poster Session, Scholarship Award & Welcome Reception

MHRA Releases Data Integrity Final GuidanceTracy Moore, GMDP Operations Manager and Senior Inspector, Inspection Enforcement & Standards Division, MHRA

Chairperson’s Opening RemarksConference Registration: Coffee & Lite Snacks On-the-Go

DAY ONE NOVEMBER 19, 2018

13:00

13:15

13:45

14:30

12:00

Tips on Handling Regulatory Inspections – Witness a Mock InspectionTracy Moore, GMDP Operations Manager and Senior Inspector, Inspection Enforcement & Standards Division, MHRAKevin O’Donnell, Ph.D., Market Compliance Manager, HPRAQRM in the GMP Environment beyond 2020 - What Should We Strive for? Kevin O’Donnell, Ph.D., Market Compliance Manager, HPRA

Prepare for the FDA Inspection Coming Soon to a Facility Near YouJR Humbert, Head/Director, Technical and Validation Standards, Genentech

16:30Impact of Human Factors on Data IntegrityNorman Fraley, Executive Director, Frolich Institute

19-21 November 2018 | The Spencer Hotel | Dublin, Ireland

PLATINUM SPONSOR

Networking Refreshment Break10:00

Select Between Knowledge Exchange Sessions8:30-10:00

Select Between Knowledge Exchange SessionsDevelop a Systematic Approach for Knowledge Management – A Key Element of ICH Q10Nuala Calnan, Adjunct Research Fellow, Dublin Institute of Technology Risk Management Tools for ValidationTara Scherder, Partner, SynoloStatsIdentify and Investigate Root Causes of Data Integrity LapsesChris Wubbolt, Principal Consultant, QACV Consulting, LLCStrategies to Move from Paper to Electronic SystemsDhruvin Patel, Manager, Change Control & Documentation, Allergan

Commissioning, Qualification and Validation (CQV) – Implementation of a Risk-based Verification StrategyAlice Redmond, Vice President, Europe Operations, CAICleaning Validation and Critical Cleaning Processes – Key Elements to a Successful ProgramDavid W. Vincent, Ph.D., CEO, VTI Life SciencesProcess Validation Statistics for Business Sakes – Statistics for Non-StatisticiansTara Scherder, Partner, SynoloStatsKatherine Giacoletti, Partner, SynoloStatsConstruction of a DI Program from the Ground UpMatthew LaPierre, Data Integrity Program Manager, Ipsen Bioscience

Coffee and Lite Breakfast7:00 7:30-8:15

DAY TWO NOVEMBER 20, 2018

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Select Between Knowledge Exchange Sessions10:30-12:00

Risk-based IQ/OQ/PQ Development and ExecutionPhilip Jarvis, Site Validation Lead, AlconImplementation of a 3-Stage Process Validation ApproachCli� Campbell, Cliff Campbell Consulting Ltd.

Lunch and Learn Sessions12:00

Cybersecurity, Data Integrity & Validation – Addressing Malicious Threats to the Life Science IndustrySteve Thompson, Senior Manager, Professional Services, ValGenesis, Inc. – South San Francisco, CAKey Components to Build and Maintain Computer System Validation (CSV)Chinmoy Roy, Data Integrity and CSV SME, Consultant, formerly Technical Team Lead, Genentech

Training Techniques for Compliant Validation ExecutionJoseph Zec, Associate Director, CSV and Compliance, Shire plcLatest Annex 15 Good Practice Updates – Apply Best Practices and Meet Regulatory ExpectationsMark Thompson, Managing Director, Mark Thompson Life Sciences Ltd.Navigate the Maze of Recent International Data Integrity RegulationsNuala Calnan, Adjunct Research Fellow, Dublin Institute of TechnologyImplement Validation Protocols for Excel™ SpreadsheetsRashida Ray, President, Array Validation Quality and Compliance (AVQC), Inc.

SILVER SPONSORS

Select Between Knowledge Exchange Sessions

DAY THREE NOVEMBER 21, 2018

7:00 Coffee and Lite Breakfast

14:45 Afternoon Refreshment Break

16:45 Close of Day Two

7:30–8:15 Select Between Knowledge Exchange Sessions

13:15–14:45

Manage a Large Commissioning, Qualification & Validation (CQV)Project as Part of a Tech Transfer to an Existing Facility Patrick Mullin, Senior CQV/QAV Consultant, DPS Group GlobalLeverage Design of Experiments to Define an Effective Control StrategyKatherine Giacoletti, Partner, SynoloStats LLC Preparing for and Performing a Data Integrity AuditRobert J. Wherry, MSc, MS, CQA, CPGP, CPIP, Head – R&D Data Systems QA & Compliance, ShireManage Changes in Computer SystemsDhruvin Patel, Manager, Change Control & Documentation, Allergan

Apply Quality Risk Management (QRM) in Equipment QualificationPatrick Mullin, Senior CQV/QAV Consultant, DPS Group GlobalThe Validation Master Plan – What You Need to Know to Avoid Becoming a Fixer UpperJR Humbert, Head/Director, Technical and Validation Standards, Genentech, South San Francisco USACloud Qualification – A GDPR Compliant Approach for SAAS, IAAS & Other Software ServicesChris Wubbolt, Principal Consultant, QACV Consulting, LLC Implementing a Risk-based Approach to Computer Systems Validation Joseph Zec, Associate Director, CSV and Compliance, Shire plc

Select Between Knowledge Exchange Sessions 15:15–16:45

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Laboratory Qualification – Temperature Mapping and Storage ChambersPatrick Mullin, Senior CQV/QAV Consultant, DPS Group GlobalUser Requirements & Implementation of a Risk-based, DI Compliant Cleaning Validation Management SystemParsa Famili, President & CEO, Novatek InternationalA Risk-based Approach to Audit TrailsJoseph Zec, Associate Director, CSV and Compliance, Shire plc DI Compliance for Paper Based Systems - The PICs approachChinmoy Roy, Data Integrity and CSV SME, Consultant, formerly Technical Team Lead, Genentech

8:30-10:00 Select Between Knowledge Exchange Sessions

An Innovative Approach to Commissioning & Qualification – Establish a Simplified & Automated Risk-based C&Q ProcessLou Killian, Director Customer Education and Success, Kneat SoftwareDevelop a Roadmap for Analytical Methods ValidationNorman Fraley, Executive Director, Frolich Institute Data Integrity – Remediation Projects and Building for the FutureAlice Redmond, Vice President European Operations, CAIDevelop an IT Infrastructure and Network Qualification RoadmapChinmoy Roy, Data Integrity and CSV SME, Consultant, formerly Technical Team Lead, Genentech

10:00 Mid-Morning Refreshment Break

Select Between Knowledge Exchange Sessions 13:00–14:30

10:30-12:00 Select Between Knowledge Exchange Sessions

12:00 Lunch and Learn Sessions

Define Requalification Frequency and Scope for Direct Impact SystemsMark Thompson, Managing Director, Mark Thompson Life Sciences Ltd.Conduct Risk-based Revalidations and Periodic Reviews of Validated SystemsPhilip Jarvis, Validation Manager, AlconDonncadh Nagle, Validation Coordinator, AvaraResponding to Data Integrity Inspection FindingsRobert J. Wherry, Head – R&D Data Systems QA & Compliance, Shire plcLab Instrument Qualification and Data IntegrityRashida Ray, President of Array Validation Quality and Compliance (AVQC), Inc.

Implement Risk Management in Change ControlGamal Amer, Ph.D. Principal, Premier Compliance ServicesEstablish Cleaning Residue Limits and Acceptance CriteriaDavid W. Vincent, Ph.D., CEO, VTI Life SciencesAdvanced Professional Master ClassSpeaker To Be AnnouncedManage Vendors and Contractors on Quality Agreements and Regulatory ComplianceRobert J. Wherry, MSc, MS, CQA, CPGP, CPIP, Head – R&D Data Systems QA & Compliance, Shire

Critical Utilities – Qualification, Impact Assessments and Continuous MonitoringDavid W. Vincent, Ph.D., CEO, VTI Life SciencesVariability in Depyrogenation Efficacy in Depyrogenation TunnelsMark Thompson, Managing Director, Mark Thompson Life Sciences Ltd.Enterprise Cloud Migration – Technical and Business Road-Map, and GxP ConsiderationsImelda Mason, IT Manager, Odyssey Validation Compliance Conduct a Part 11 Gap Assessment Rashida Ray, President, Array Validation Quality and Compliance (AVQC), Inc.

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14:30 Afternoon Refreshment Break 15:00-16:30 Select Between Knowledge Exchange Sessions

16:30 Close of Conference

Effective Strategies to Streamline Validation ProcessesGeo� Shaw, Product Manager Pharma, Ellab UK LtdUsing Quality System Elements to Maintain Your Process Validated State Gamal Amer, Ph.D. Principal, Premier Compliance ServicesUsing a Data Integrity Maturity Model for Internal AuditsNuala Calnan, PhD, Adjunct Research Fellow Regulatory Science, Dublin Institute of TechnologyDonncadh Nagle, Validation Co-ordinator, Avara Shannon Pharmaceutical Services LimitedMoving from Paper to Electronic – A Case Study Using Electronic LogbooksMag Cordu�, QA & Compliance Specialist, Odyssey Validation Compliance

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