Commissioning, Qualification & VALIDATION UNIVERSITY

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Master Planning * Risk * Statistics * Change Control * Documentation * CPV

Master Planning * Risk * Statistics * Change Control * Documentation * CPV

November 28 - November 30

Dublin, Ireland

Val – U for Process * Cleaning * Computer Systems * Equipment * Utilities * Facilities * Data Integrity Lands in Dublin!

Knowledge Exchange Network (KENX) is very excited to announce their Validation University is going to be held in Ireland this fall. The event is a dream come true for engineering, quality, C&Q and validation professionals by offering hands-on training for the pharmaceutical, biotech, medical device and related industries. Participants create their own experience by choosing from over 38 tutorials and benefit from the wealth of knowledge and useful material our faculty exchanges. Val-U offers a hands-on experience in which lessons learned turn into immediate, actionable results.  

 

38 Tutorials Overflowing with Rich Content and Tangible Takeaways for the CQV Universe

 

  • Commissioning & Qualification

Implement a Lean, Risk-Based Verification Approach

Identify Nonconformances and Improve Outcomes

Conduct Compliant Utility Qualification Processes

Understand New System URS & Qualification Processes (DQ, IQ, OQ, PQ)

 

  • Process Validation

Master Critical Elements Including Statistical Sampling Plans

Establish Critical Process Parameters (CPP) and Critical Quality Attributes (CQA)

Implement a Compliant Continued Process Verification (CPV) Programme

Manage Variability by Using Design of Experiments (DoE)

 

  • Cleaning Validation

Examine Health-Based Cleaning Limit Formulas

Establish Acceptance Criteria and Set Active Ingredient Limits

Resolve Issues and Deviations During Protocol Execution

Implement a Risk-Based Approach & Understand Critical Processes

 

  • Computer System Validation

Master A Life Cycle Approach and Implement Enterprise-Wide

Qualify Cloud Infrastructures and Mobile Devices

Perform a Part 11 Gap Assessment

Conduct a Functional Risk Assessment (FRA) on a Complex System

 

  • Data Integrity Compliance

Ensure Governance Throughout the Life Cycle

Learn how to Conduct Risk Assessments and Investigate Root Causes

Prepare for and Handle Investigators in a Regulatory Audit

Implement System Safeguards and Controls

 

 

  • LEADING ORGANIZATIONS SHOWCASING BEST-IN-CLASS INNOVATION AND PROCESSES, INCLUDING:

Agidens Life Sciences * Bausch + Lomb * Bayer * BioMarin * Bio Products Laboratories * Bristol-Myers Squibb * Commissioning Agents, Inc. * Dublin Institute of Technology * ICQ * Odyssey VC * Rescop * Sanofi * Shire * ValGenesis * Validant * VTI Life Sciences * Medicines & Healthcare Products Regulatory Agency (MHRA)

 

  • RECEIVE OVER 2 DOZEN TEMPLATES, TOOLS, SOPS, CHECKLISTS AND OTHER USEFUL TOOLS, INCLUDING:

Risk Based Verification Process Flow * Lifecycle Verification Plan IOQ Report * Commissioning Document (with Lean Approvals) * Process Risk Assessment * Test Scripts and User Requirements * IOQ Protocol * PQ Protocol * Monitoring Plan * Cleaning Validation Periodic Review * Cleaning Validation Protocol * Data Integrity Checklist * URS Process Flow and Responsibilities * IQ/OQ Infrastructure * DoE Protocol

Personnel in the Following Environments Should Attend:

  • Validation
  • QA/QC
  • Engineering
  • C&Q
  • Regulatory and Compliance
  • Facility Management
  • Manufacturing
  • Laboratory

 

This event is also appropriate to business development and sales managers that offer innovative solutions for quality, validation and engineering professionals in the lifescience environment.

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) – 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
  • 16:15
    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
    Data Integrity Requirements and Audit Trails
    (1) Data Integrity Requirements and Audit Trails Richard Mulders, Senior CSV Consultant & Director Rescop Academy, Rescop
  • (2) e-Validation
    Excel in Validation with e-Validation Solutions
    To Be Announced
  • 08:30 – 12:00
    Select Between Execution and Master Planning Workshops (A-D)
  • (A)
    Lean Implementation of a Risk-Based Verification Approach for Commissioning & Qualification (C&Q)
    Philip Jarvis, Validation and QA Senior Manager, BioMarin Shanbally
  • (B)
    Master A Life Cycle Approach for Computer Systems & Software Validation
    Thomas O’Brien, Validation Engineer, Bristol-Myers Squibb
  • (C)
    Walk Through a Process Validation Implementation Case Study
    David W. Vincent, CEO, VTI Life Sciences
  • (D)
    Cleaning Validation Considerations for Manufacture of Biopharmaceuticals
    Joe Brady, Lecturer, School of Chemical and Pharmaceutical Sciences, Dublin Institute of Technology
  • 13:15 – 14:45
    Select Between Knowledge Exchange Sessions (3-6)
  • (3)
    Identify Validation Nonconformances and Improve Outcomes – A QA Perspective
    Karen Mullin, Senior QA Operations, Shire
  • (4)
    Qualification of Critical Utilities
    Mark Thompson, Managing Director, Mark Thompson Lifesciences Ltd.
  • (5)
    Establishing Acceptance Criteria for Cleaning Validation
    Fred Ohsiek, Senior Manager Cleaning Validation, Bayer Berkeley
  • (6)
    Data Integrity Governance – A Life Cycle Approach to Compliance
    Richard Mulders, Senior CSV Consultant & Director Rescop Academy, Rescop
  • 15:15 – 16:45
    Select Between Knowledge Exchange Sessions (7-10)
  • (7)
    Develop and Execute Storage Temperature Mapping Validations
    Jorge A. Cordero, BSChE, BA-GM, Validation and Metrology Site Lead, Bausch + Lomb
  • (8)
    Establish a Compliant Continued Process Verification (CPV) Programme Based on Annex 15
    Philip Jarvis, Validation and QA Senior Manager, BioMarin Shanbally
  • (9)
    Walk through Three CQV Journeys
    Alice Redmond, Vice President, European Operations, Commissioning Agents, Inc.
  • (10)
    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 (11-13)
  • (11)
    Medical Device Master Class – Design Studies, Protocols, Validation, Reports and More
    To Be Announced
  • (12)
    Perform Test Instrument and System Calibration Verifications
    Charles Cotter, Senior Validation Consultant, Sanofi
  • (13)
    Building Bridges – Harmonizing Engineering, Quality, Validation and IT
    Ivan Soto, Director Client Engagement & Product Strategy, ValGenesis Systems
  • 08:30 – 10:00
    Select Between Knowledge Exchange Sessions (14-17)
  • (14)
    Take your Quality Risk Management (QRM) to the Next Level
    Kelly Waldron, Senior Consultant, Valsource and Regulatory Science Researcher, Dublin Institute of Technology (DIT)
  • (15)
    Cleaning Validation Visual Inspection Overview and Applications
    Fred Ohsiek, Senior Manager Cleaning Validation, Bayer
  • (16)
    New System User Requirement Specification & Qualification (DQ, IQ, OQ, PQ)
    Ivan Diamond, Site Data Integrity Lead, Bio Products Laboratories
  • (17)
    Qualifying Cloud Infrastructure and Mobile Devices
    Juanita Lynch, CSV Compliance, Odyssey VC
  • 10:30 – 12:00
    Select Between Knowledge Exchange Sessions (18-21)
  • (18)
    Cleanroom Design and Environmental Monitoring
    David W. Vincent, CEO, VTI Life Sciences
  • (19)
    Integrated Commissioning and Validation of New Biotech and Pharma Facilities
    Patrick Mullin, Validation Manager, Shire – Mike Bogan, President, Integrated Commissioning and Qualification Consultants, Corp. (ICQ)
  • (20)
    Conduct a Part 11 Gap Assessment
    Ivan Soto, Director Client Engagement & Product Strategy, ValGenesis Systems
  • (21)
    Implement Validation Protocols for Excel™ Spreadsheets
    Micheal Quealy, Senior Commissioning Lead, Commissioning Agents (CAI), Ireland
  • 13:00 – 14:30
    Choose Between Knowledge Exchange Sessions (22-25)
  • (22)
    Hiring the People Who Make Validation Great
    Patrick Mullin, Validation Manager, Shire
  • (23)
    Requalify Equipment, Systems, and Processes
    Jorge A. Cordero – BSChE, MBA-GM, Validation and Metrology Site Lead, Bausch + Lomb
  • (24)
    Using Design of Experiments (DoE) in Process Validation
    Ivan Soto, Director Client Engagement & Product Strategy, ValGenesis Systems
  • (25)
    Effective Strategies to Validate Automated Manufacturing Software
    Bjorn Struyf, GxP Project Manager, Agidens Life Sciences
  • 15:00 – 16:30
    Select Between Knowledge Exchange Sessions (26-29)
  • (26)
    Advanced Professional Master Class
    Karen Mullin, Senior QA Operations, Shire, Lexington, MA.
  • (27)
    Decommissioning – The End of the Life Cycle – Do I have something to do next?
    Charles Cotter, Senior Validation Consultant, Sanofi
  • (28)
    Risk Assessment on A Complex Computer Systems – Functional Risk Assessment (FRA) for Manufacturing Execution Systems (MES)
    Juanita Lynch, CSV Compliance, Odyssey VC
  • (29)
    Prepare for and Handle Investigators on Data Integrity Compliance
    Micheal Quealy, Senior Commissioning Lead, Commissioning Agents (CAI), Ireland

Faculty

  • Michael Bogan, President, ICQ

    Michael Bogan, President of Integrated Commissioning and Qualification Consultants, Corp. (ICQ) has been working in the life science industry for 25 years, supporting operating companies, facility expansions, and green field projects. Mike and ICQ have designed and implemented multiple large scale integrated C&Q projects for clients including Sanofi Pasteur, Mannkind, Sanofi Genzyme, and Shire. Over the years ICQ's clients have realized significant savings in C&Q implementation costs, and continue to benefit from robust and compliant C&Q systems in support of ongoing cGMP operations.
  • Joe Brady, Lecturer, School of Chemical and Pharmaceutical Sciences, Dublin Institute of Technology

    Joe is a highly experienced pharmaceutical professional and has over 20 years combined project, operational and training experience in the pharmaceutical, biopharmaceutical and medical device industries in Ireland, Singapore, China, The Netherlands, France and the USA. Specialties include; process and cleaning validation, GMP facility design, CSV, electronic records, risk management and more.
  • 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, 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.
  • Philip Jarvis, Validation and QA Senior Manager, BioMarin

    Mr. Jarvis is an experienced team leader with over ten years of experience in all areas of validation including; process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation. Through strategic thinking, he has success in steering and managing complex validation projects within the medical device and pharmaceutical industries. His accomplishments also expands into a successful start-up biotech facility with the world’s largest perfusion process.
  • 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.
  • Karen Mullin, Senior QA Operations, Shire

    Karen Mullin has over 16 years of industry experience specializing in GMP Quality System development and validation. After earning a Master of Science degree in Analytical Chemistry, Karen began her career as a method development/validation chemist supporting small molecules and biologics in research and clinical trial development. Karen is currently a senior member of the QA Operations team at Shire's Lexington, MA location, working closely with Manufacturing and Validation to resolve complex deviations and ensure compliance and the highest standards of patient safety and product supply.
  • 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).
  • Kevin O’Donnell, Ph.D., Market Compliance Manager, Health Products Regulatory Authority (HPRA)

    Kevin O’Donnell, Ph.D. was appointed to Market Compliance Manager. In this position, at HPRA, Kevin is a member of the senior management team of the Compliance Department and holds responsibility for various compliance programmes such as  HPRA's Sampling & Analysis Programme (Medicinal Products and Active Substances): HPRA's Quality Defect & Recall Programme (Medicinal Products and Active Substances):  HPRA's Exempt Medicinal Products Programme:  HPRA's Advertising Compliance Programme:  HPRA's Regulatory Compliance Inspection Programme at Marketing Authorisation Holder.
  • Alice Redmond, Vice President, European Operations, Commissioning Agents, Inc.

    Alice Redmond is Vice President, Europe Operations at CAI. She has more than 28 years’ extensive experience in lifecycle management of pharma facilities inclusive of regulatory compliance, facility & process design, technology transfer, commissioning, qualification, and validation. Previously Ms. Redmond worked for 9 years for Sandoz/Novartis in the areas of quality, validation and technical operations. Following Novartis, Alice led the global regulatory, commissioning and qualification group for a global engineering company for 13 years.
  • Fred Ohsiek, Senior Manager Cleaning Validation, Bayer

    Fred Ohsiek, is the senior manager of Cleaning Validation and site cleaning validation SME for Bayer U.S. LLC, located in Berkeley CA. He earned his BS in Chemistry from University of South Florida. His professional work experience includes 7 years of R&D performing enzymatic digestion, ultrafiltration and fermentation on citrus peel while working for the USDA and 18 years of cleaning validation while working at various pharmaceutical companies. He has been considered the cleaning validation subject matter expert in most of the positions held.
  • 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.
  • Mark Thompson, Managing Director, Mark Thompson Lifesciences

    Mark Thompson is a chartered engineer with 30 years industry experience. Following engineering management roles at Eli Lilly, Sanofi Aventis and Smith + Nephew, in 2000 Mark started providing consultancy and training services in sterile product manufacture and over the last 17 years this consultancy and training support has been delivered all over the world to hundreds of organisations.
  • 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.
  • David W. Vincent, CEO, VTI Life Sciences

    Mr. Vincent has over 33 years’ experience in the health care industry specializing in the, biologic, biotechnology and biopharmaceutical industries and has over 25 years dedicated to the field of validation. Mr. Vincent has provided both project management and project execution for numerous clients national and international. He is responsible for managing and supporting many different product launches. He teaches at San Diego State University (SDSU) for their Masters of Regulatory Affairs Degree program in the Field of Validation Technology RA-776.
  • Kelly Waldron, Senior Consultant, Valsource and Regulatory Science Researcher, Dublin Institute of Technology (DIT)

    Kelly Waldron is an industry expert in Quality Risk Management (QRM). She is currently a Senior Consultant with Valsource and is pursuing her PhD in QRM from the Dublin Institute of Technology. She has over fourteen years of experience in various quality functions in the pharmaceutical, biopharmaceutical, and medical device industries, with nine years focused on QRM. Kelly has authored several industry and academic papers on QRM and most recently, she served as a member of the PDA Task Force that recently released PDA Technical Report 54-5, “QRM in Design, Commissioning, and Qualification.”

Sponsors

Partners

Venue

Details

Start:
November 28
End:
November 30
Cost:
Free
Event Category:
Website:
https://www.kenx.org/

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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