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Computer Systems Validation (CSV) & Data Integrity Compliance Congress

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Governance | Compliance | Validation

November 28, 2017 - November 30, 2017

Dublin, Ireland

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 Philadelphia and showcases the protocols, methodology and actions necessary to avoid regulatory action.

Choose from Over 15 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
  • Know the Expectations for and Handle Issues in the Analytical Lab
  • Perform a Risk Assessment for Deficiencies
  • Understand Requirements and How to Handle Audit Trails

 

Personnel in the Following Environments Should Attend:

  • Validation
  • Quality Assurance
  • 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

  • 13:00
    Chairperson’s Opening Remarks
  • 13:15
    Regulatory Town Hall Meeting – Receive Critical Insight on Data Integrity and Other CQV Regulations, Inspections and Trends
    Tracy Moore, GMDP Operations Manager and Senior Inspector, Medicines & Healthcare Products Regulatory Agency (MHRA) -- Kevin O’Donnell, Ph.D., Market Compliance Manager, Health Products Regulatory Authority (HPRA – Invited) -- Ivan Diamond, Site Data Integrity Lead, Bio Products Laboratories -- Nuala Calnan, PhD, Adjunct Research Fellow Regulatory Science, Dublin Institute of Technology
  • 14:15
    CSV & Data Integrity Risk Management Tools and Techniques
    Ivan Diamond, Site Data Integrity Lead, Bio Products Laboratories
  • 15:30
    Effective Change Control Process for Facilities, Equipment and Computer Systems
    Ivan Soto, Director Client Engagement & Product Strategy, ValGenesis
  • 15:30
    Leverage Technical Transfer and Engineering Studies in Process Validation
    Jorge A. Cordero, BSChE, BA-GM, Validation and Metrology Site Lead, Bausch + Lomb
  • 17:00
    Dublin Institute of Technology Poster Session, Academic Donation & Awards Reception
  • 07:30 – 08:15
    Select Between Knowledge Exchange Sessions (1-2)
  • (1)
    Data Integrity Requirements and Audit Trails
    Richard Mulders, Senior CSV Consultant & Director Rescop Academy, Rescop
  • (2)
    Excel in Validation with e-Validation Solutions
    To Be Announced
  • 08:30 – 12:00
    3-Hour Tutorial
  • Master A Life Cycle Approach for Computer Systems & Software Validation
    Thomas O’Brien, Validation Engineer, Bristol-Myers Squibb
  • 13:15 – 14:45
    90 Minute Tutorial
  • Data Integrity Governance – A Life Cycle Approach to Compliance
    Richard Mulders, Senior CSV Consultant & Director Rescop Academy, Rescop
  • 15:15 – 16:45
    90 Minute Tutorial
  • Identify and Investigate Root Causes of Data Integrity Lapses
    Ivan Diamond, Site Data Integrity Lead, Bio Products Laboratories
  • 07:30 – 08:15
    Select Between Knowledge Exchange Breakfasts (3-5)
  • (3)
    Medical Device Master Class – Design Studies, Protocols, Validation, Reports and More
    To Be Announced
  • (4)
    Perform Test Instrument and System Calibration Verifications
    Charles Cotter, Senior Validation Consultant, Sanofi
  • (5)
    Building Bridges – Harmonizing Engineering, Quality, Validation and IT
    Ivan Soto, Director Client Engagement & Product Strategy, ValGenesis Systems
  • 08:30 – 10:00
    Choose Between Knowledge Exchange Sessions (6-7)
  • (6)
    New System User Requirement Specification & Qualification (DQ, IQ, OQ, PQ)
    Ivan Diamond, Site Data Integrity Lead, Bio Products Laboratories
  • (7)
    Qualifying Cloud Infrastructure and Mobile Devices
    Juanita Lynch, CSV Compliance, Odyssey VC
  • 10:30 – 12:00
    Select Between Knowledge Exchange Sessions (9-10)
  • (9)
    Conduct a Part 11 Gap Assessment
    Ivan Soto, Director Client Engagement & Product Strategy, ValGenesis Systems
  • (10)
    Implement Validation Protocols for Excel™ Spreadsheets
    Micheal Quealy, Senior Commissioning Lead, Commissioning Agents (CAI), Ireland
  • 13:00 – 14:30
    Select Between Knowledge Exchange Sessions (11-12)
  • (11)
    Hiring the People Who Make Validation Great
    Patrick Mullin, Validation Manager, Shire
  • (12)
    Effective Strategies to Validate Automated Manufacturing Software
    Bjorn Struyf, GxP Project Manager, Agidens Life Sciences
  • 15:00 – 16:30
    Choose Between Knowledge Exchange Sessions (13-14)
  • (13)
    Perform a Risk Assessment on a Complex Computer System – Functional Risk Assessment (FRA) for Manufacturing Execution Systems (MES)
    Juanita Lynch, CSV Compliance, Odyssey VC
  • (14)
    Prepare for and Handle Investigators on Data Integrity Compliance
    Micheal Quealy, Senior Commissioning Lead, Commissioning Agents (CAI), Ireland

Faculty

  • Nuala Calnan, PhD, Adjunct Research Fellow Regulatory Science, Dublin Institute of Technology

    Nuala Calnan, PhD has over 20 years’ experience in the pharmaceutical industry and is currently an Adjunct Research Fellow with the Pharmaceutical Regulatory Science Team at DIT, Ireland, where she leads a number of patient focused regulatory science research projects at Masters and PhD level. Nuala’s focus is on the integration of Knowledge Excellence, Operational Excellence, & Cultural Excellence in delivering enhanced quality outcomes for the patient and has led a recent Irish Industry research study in this field examining the Product Recall and Quality Defect data at the Irish medicines regulator, HPRA.
  • Jorge A. Cordero, BSChE, BA-GM, Validation and Metrology Site Lead, Bausch + Lomb

    Jorge A. Cordero has over nineteen (19) years of experience in the biotechnology, pharmaceutical, medical devices and municipality industries in the technical services and management areas, including validation, engineering specification, and equipment design specification. Currently, Jorge is working with Bausch + Lomb managing the validation and metrology departments.
  • 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.
  • Ivan Diamond, Site Data Integrity Lead, Bio Products Laboratories

    Ivan Diamond, MBA. has worked within the Pharmaceutical industry for over 20 years across a diverse range of product presentations including actives, solid dosage, liquids, parenteral preparations and high potency treatments. He has held a number of key positions including subject matter expert, auditor, head of function, quality director and successfully dealt with regulatory authority inspections from FDA, MHRA, Turkish Ministry of Health and German Ministry of health.
  • Tom Kerkhofs, Business Development GxP Testing & Inspection, Agidens Life Sciences

    Mr. Kerkhofs is an experienced validation consultant with almost ten years of experience in equipment qualification, csv, thermal validation, temperature mapping & utility qualification. Various projects, executed at large multinationals, contract manufacturers & hospitals, were successfully completed. These cross-sectorial experiences led to a pragmatic, quality-minded view on validation.
  • Juanita Lynch, CSV Compliance, Odyssey VC

    Ms. Juanita Lynch has extensive experience spanning over 10 years in the areas of computer system validation, equipment validation, process validation, quality assurance and compliance. currently operating in a compliance capacity in the field of computer systems validation, Juanita provides her expertise to major multi – national pharmaceutical/medical device organisations working on various computer system projects from a GXP perspective.
  • Tracy Moore, Senior GMDP Inspector and GMDP Operations Manager, Medicines and Healthcare Products Regulatory Agency (MHRA)

    Tracy has been with the MHRA GMP Inspectorate since 2011 and before joining the MHRA worked in the pharmaceutical industry for over 23 years. She worked across all dosage forms within Quality roles and is eligible to act as a Qualified Person under 2001/83. Tracy is the newly appointed lead for the Agency team responsible for delivering data integrity strategy and training.
  • Richard Mulders, Senior CSV Consultant & Director Rescop Academy, Rescop

    Richard is a senior compliance professional with a background in software development and with over 10 years of experience in computerized system validation, data migration, and auditing in the pharmaceutical and medical device industry. He has worked on diverse system validation, data migration, and data integrity governance projects for diverse multi-nationals. He is the initiator of the Rescop Academy, which provides training and lectures on compliance topics at companies, congresses, and as part of diverse Bachelor and University Master programs.
  • Patrick Mullin, Validation Manager, Shire

    Patrick Mullin has over 15 years of experience in vaccine and biotech operations which include commissioning, qualification, and validation (CQV) management for clinical and commercial scale biotech operations. Patrick's core focus is with the creation, implementation, and maintenance of CQV programs specializing in critical utilities, process equipment, process automated systems, and sterilization/cleaning support systems. Patrick currently works at Shire as a validation manager responsible for facilities, equipment, and utilities validation for two commercial manufacturing sites within Shire's Lexington, MA location.
  • Thomas O'Brien, Validation Engineer, Bristol-Myers Squibb

    Mr. O’Brien received his BSc. in BioChemistry and Chemistry from University College Dublin Ireland. His career includes positions that has given extensive knowledge throughout the validation and GMP environments, including; Senior Manufacturing Technologist (Ispen), Quality Control Analyst (Wyeth Medica/Pfizer), Validation Lead (GSK), Senior Validation Engineer (Sanofi) and Computer Systems Validation Engineer (BMS).
  • Ivan Soto, Director Client Engagement & Product Strategy, ValGenesis Systems

    Mr. 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. is currently Director Client Engagement & Product Strategy, ValGenesis Systems.
  • Bjorn Struyf, GxP Project Manager, Agidens Life Sciences

    Mr. Struyf is an experienced project manager with over ten years of experience in GxP projects including: automated equipment validation, facilities validation, utilities validation, CSV, product transfer and life cycle management projects. As a consultant, he was involved in several green field projects and responsible to define and coordinate the validation effort.
  • Micheal Quealy, Senior Commissioning Lead, Commissioning Agents (CAI), Ireland

    Micheal Quealy is an Automation/CSV SME with 16 years’ experience in the Life Science industry. He has experience in the implementation of numerous automation systems from design to realization, including packaging lines, process control systems, SCADA systems, virtual environments and CMMS. He is an SME in all areas of Data Integrity and has attended and presented at various conferences on the subject.

Sponsors

Partners

Venue

Details

Start:
November 28, 2017
End:
November 30, 2017
Cost:
Free
Event Category:

Venue

The Spencer Hotel
Excise Walk, IFSC
Dublin, County Dublin Dublin 1 Ireland
+ Google Map
Phone:
+353 1 433 8800
Website:
http://www.thespencerhotel.com/

Pricing & Registration

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