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Commissioning, Qualification & VALIDATION UNIVERSITY

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Continued Verification * Master Planning * Risk * Statistics * Change Control * Data Integrity

November 19 - November 21

Dublin, Ireland

VALIDATION UNIVERSITY RETURNS TO DUBLIN!

Knowledge Exchange Network (KENX) is very excited to announce their Validation University is returning to 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 40 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.  

 

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

 

Commissioning & Qualification

  • Implement a Risk-based Verification Strategy
  • Harness Product and Process Knowledge to Drive a Risk-based IQ, OQ, and PQ Approach
  • Manage a Large CQV Project as Part of a Tech Transfer to an Existing Facility
  • Qualify Temperature Mapping and Storage Chambers

 

Process Validation

  • Learn How To Use Statistics in Validation – Statistics for Non-Statisticians
  • Implement a 3-Stage Process Validation Approach
  • Master the Validation Master Plan (VMP)
  • Conduct Risk-based Revalidations and Periodic Reviews of Validated Systems

 

Cleaning Validation

  • Understand Key Elements to a Successful Program
  • Establish Cleaning Residue Limits and Acceptance Criteria
  • Establishing Bioburden and Endotoxin limits for Sterile and Non-sterile Products and Processes
  • Receive a Cleaning Validation Assessment Checklist Example

 

Computer System Validation

  • Cybersecurity – Addressing Malicious Threats to the Life Science Industry
  • Master the Key Components to Build and Maintain an Inspection-proof Program
  • Discover a GDPR Compliant Approach for SAAS, IAAS, and Other Software Services
  • Develop an IT Infrastructure and Network Qualification Roadmap

 

Data Integrity Compliance

  • Construct a Program from the Ground Up
  • Prepare for and Perform a Data Integrity Audit
  • See Remediation Projects and How to Build for the Future
  • Know How to Respond to Data Integrity Inspection Findings

 

FEATURED REGULATORY KICKOFF

MHRA Releases Data Integrity Final Guidance

Tracy Moore, GMDP Operations Manager and Senior Inspector, Inspection Enforcement & Standards Division, MHRA

Change Control and Risk Reduction – Two Sides of the Same Coin?

Kevin O’Donnell, Ph.D., Market Compliance Manager, HPRA

PLUS! Receive Tips from MHRA and HPRA on Handling Regulatory Inspections – Observe Tracy and Kevin Participate in a Mock Inspection

 

See Dublin Events Agenda-At-A-Glance – Click Here

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 for business development and sales managers that offer innovative solutions for quality, validation and engineering professionals in the life science environment.

Agenda

  • 12:00
    Conference Registration
    Coffee & Lite Snacks On-the-Go
  • 13:00
    Chairperson’s Opening Remarks
  • 13:15
    MHRA Releases Data Integrity Final Guidance
    Tracy Moore, GMDP Operations Manager and Senior Inspector, Inspection Enforcement & Standards Division, MHRA
  • 13:45
    Tips on Handling Regulatory Inspections – Witness a Mock Inspection
    Tracy Moore, GMDP Operations Manager and Senior Inspector, Inspection Enforcement & Standards Division, MHRA | Kevin O’Donnell, Ph.D., Market Compliance Manager, HPRA
  • 14:30
    Change Control and Risk Reduction – Two Sides of the Same Coin?
    Kevin O’Donnell, Ph.D., Market Compliance Manager, HPRA
  • 15:00
    Afternoon Refreshment Break
  • 15:30
    Prepare for the FDA Inspection Coming Soon to a Facility Near You
    JR Humbert, Head/Director, Technical and Validation Standards, Genentech
  • 16:30
    Impact of Human Factors on Data Integrity
    Norman Fraley, Executive Director, Frolich Institute
  • 17:15
    DIT Dublin Institute of Technology Poster Session, Scholarship Award & Welcome Reception
  • 7:00
    Coffee and Lite Breakfast
  • 7:30-8:15
    Select Between Knowledge Exchange Sessions:
  • (1)
    Develop a Systematic Approach for Knowledge Management – A Key Element of ICH Q10
    Nuala Calnan, Adjunct Research Fellow, Dublin Institute of Technology
  • (2)
    Risk Management Tools for Validation
    Tara Scherder, Partner, SynoloStats
  • (3)
    Identify and Investigate Root Causes of Data Integrity Lapses
    Chris Wubbolt, Principal Consultant, QACV Consulting, LLC
  • (4)
    Strategies to Move from Paper to Electronic Systems
    Dhruvin Patel, Manager, Change Control & Documentation, Allergan
  • 8:30-10:00
    Select Between Knowledge Exchange Sessions:
  • (5)
    Commissioning, Qualification and Validation (CQV) – Implementation of a Risk-based Verification Strategy
    Alice Redmond, Vice President, Europe Operations, CAI
  • (6)
    Cleaning Validation and Critical Cleaning Processes – Key Elements to a Successful Program
    David W. Vincent, Ph.D., CEO, VTI Life Sciences
  • (7)
    Process Validation Statistics for Business Sakes – Statistics for Non-Statisticians
    Tara Scherder, Partner, SynoloStats Katherine Giacoletti, Partner, SynoloStats
  • (8)
    Construction of a DI Program from the Ground Up
    Matthew LaPierre, Data Integrity Program Manager, Ipsen Bioscience
  • 10:00
    Networking Refreshment Break
  • 10:30-12:00
    Select Between Knowledge Exchange Sessions:
  • (9)
    Risk-based IQ/OQ/PQ Development and Execution
    Philip Jarvis, Site Validation Lead, Alcon
  • (10)
    Implementation of a 3-Stage Process Validation Approach
    Cli Campbell, Cliff Campbell Consulting Ltd.
  • (11)
    Cybersecurity, Data Integrity & Validation – Addressing Malicious Threats to the Life Science Industry
    Steve Thompson, Senior Manager, Professional Services, ValGenesis, Inc. – South San Francisco, CA
  • (12)
    Key Components to Build and Maintain Computer System Validation (CSV)
    Chinmoy Roy, Data Integrity and CSV SME, Consultant, formerly Technical Team Lead, Genentech
  • 12:00
    Lunch and Learn Sessions
  • (13)
    Training Techniques for Compliant Validation Execution
    Joseph Zec, Associate Director, CSV and Compliance, Shire plc
  • (14)
    Latest Annex 15 Good Practice Updates – Apply Best Practices and Meet Regulatory Expectations
    Mark Thompson, Managing Director, Mark Thompson Life Sciences Ltd.
  • (15)
    Navigate the Maze of Recent International Data Integrity Regulations
    Nuala Calnan, Adjunct Research Fellow, Dublin Institute of Technology
  • (16)
    Implement Validation Protocols for Excel™ Spreadsheets
    Rashida Ray, President, Array Validation Quality and Compliance (AVQC), Inc.
  • 13:15–14:45
    Select Between Knowledge Exchange Sessions:
  • (17)
    Manage a Large Commissioning, Qualification & Validation (CQV) Project as Part of a Tech Transfer to an Existing Facility
    Peju Odunusi, Group Leader, Stability, Abbott Vascular
  • (18)
    Leverage Design of Experiments to Define an Effective Control Strategy
    Katherine Giacoletti, Partner, SynoloStats LLC
  • (19)
    Preparing for and Performing a Data Integrity Audit
    Robert J. Wherry, MSc, MS, CQA, CPGP, CPIP, Head – R&D Data Systems QA & Compliance, Shire
  • (20)
    Manage Changes in Computer Systems
    Dhruvin Patel, Manager, Change Control & Documentation, Allergan
  • 14:45
    Afternoon Refreshment Break
  • 15:15–16:45
    Select Between Knowledge Exchange Sessions:
  • (21)
    Apply Quality Risk Management (QRM) in Equipment Qualification
    Patrick Mullin, Validation Manager, Shire
  • (22)
    The Validation Master Plan – What You Need to Know to Avoid Becoming a Fixer Upper
    JR Humbert, Head/Director, Technical and Validation Standards, Genentech, South San Francisco USA
  • (23)
    Cloud Qualification – A GDPR Compliant Approach for SAAS, IAAS & Other Software Services
    Chris Wubbolt, Principal Consultant, QACV Consulting, LLC
  • (24)
    Implementing a Risk-based Approach to Computer Systems Validation
    Joseph Zec, Associate Director, CSV and Compliance, Shire plc
  • 4:45
    Close of Day Two
  • 7:00
    Coffee and Lite Breakfast
  • 7:30–8:15
    Select Between Knowledge Exchange Sessions:
  • (25)
    Laboratory Qualification – Temperature Mapping and Storage Chambers
    Patrick Mullin, Validation Manager, Shire
  • (26)
    User Requirements & Implementation of a Risk-based, DI Compliant Cleaning Validation Management System
    Parsa Famili, President & CEO, Novatek International
  • (27)
    A Risk-based Approach to Audit Trails
    Joseph Zec, Associate Director, CSV and Compliance, Shire plc
  • (28)
    DI Compliance for Paper Based Systems - The PICs approach
    Chinmoy Roy, Data Integrity and CSV SME, Consultant, formerly Technical Team Lead, Genentech
  • 8:30-10:00
    Select Between Knowledge Exchange Sessions:
  • (29)
    An Innovative Approach to Commissioning & Qualification – Establish a Simplified & Automated Risk-based C&Q Process
    Lou Killian, Director Customer Education and Success, Kneat Software
  • (30)
    Develop a Roadmap for Analytical Methods Validation
    Norman Fraley, Executive Director, Frolich Institute
  • (31)
    Data Integrity – Remediation Projects and Building for the Future
    Alice Redmond, Vice President European Operations, CAI
  • (32)
    Develop an IT Infrastructure and Network Qualification Roadmap
    Chinmoy Roy, Data Integrity and CSV SME, Consultant, formerly Technical Team Lead, Genentech
  • 10:00
    Mid-Morning Refreshment Break
  • 10:30-12:00
    Select Between Knowledge Exchange Sessions:
  • (33)
    Define Requalification Frequency and Scope for Direct Impact Systems
    Mark Thompson, Managing Director, Mark Thompson Life Sciences Ltd.
  • (34)
    Conduct Risk-based Revalidations and Periodic Reviews of Validated Systems
    Philip Jarvis, Validation Manager, Alcon | Donncadh Nagle, Validation Coordinator, Avara
  • (35)
    Responding to Data Integrity Inspection Findings
    Robert J. Wherry, Head – R&D Data Systems QA & Compliance, Shire plc
  • (36)
    Lab Instrument Qualification and Data Integrity
    Rashida Ray, President of Array Validation Quality and Compliance (AVQC), Inc.
  • 12:00
    Lunch and Learn Sessions
  • (37)
    Implement Risk Management in Change Control
    Gamal Amer, Ph.D. Principal, Premier Compliance Services
  • (38)
    Establish Cleaning Residue Limits and Acceptance Criteria
    David W. Vincent, Ph.D., CEO, VTI Life Sciences
  • (39)
    Advanced Professional Master Class
    Speaker To Be Announced
  • (40)
    Manage Vendors and Contractors on Quality Agreements and Regulatory Compliance
    Robert J. Wherry, MSc, MS, CQA, CPGP, CPIP, Head – R&D Data Systems QA & Compliance, Shire
  • 13:00–14:30
    Select Between Knowledge Exchange Sessions:
  • (41)
    Critical Utilities – Qualification, Impact Assessments and Continuous Monitoring
    David W. Vincent, Ph.D., CEO, VTI Life Sciences
  • (42)
    Variability in Depyrogenation Efficacy in Depyrogenation Tunnels
    Mark Thompson, Managing Director, Mark Thompson Life Sciences Ltd.
  • (43)
    Enterprise Cloud Migration – Technical and Business Road-Map, and GxP Considerations
    Imelda Mason, IT Manager, Odyssey Validation Compliance
  • (44)
    Conduct a Part 11 Gap Assessment
    Rashida Ray, President, Array Validation Quality and Compliance (AVQC), Inc.
  • 14:30
    Afternoon Refreshment Break
  • 15:00-16:30
    Select Between Knowledge Exchange Sessions:
  • (45)
    Effective Strategies to Streamline Validation Processes
    Geoff Shaw, Product Manager Pharma, Ellab UK Ltd
  • (46)
    Using Quality System Elements to Maintain Your Process Validated State
    Gamal Amer, Ph.D., Principal, Premier Compliance Services, Inc.
  • (47)
    Using a Data Integrity Maturity Model for Internal Audits
    Nuala Calnan, PhD, Adjunct Research Fellow Regulatory Science, Dublin Institute of Technology | Donncadh Nagle, Validation Co-ordinator, Avara Shannon Pharmaceutical Services Limited
  • (48)
    Moving from Paper to Electronic – A Case Study Using Electronic Logbooks
    Mag Corduff, QA & Compliance Specialist, Odyssey Validation Compliance
  • 16:30
    Close of Conference

Faculty

  • Gamal Amer, Principal, Premier Compliance Services

    Dr. Amer, a chemical engineer by training, has 40 years-experience in the pharmaceutical and related industries. He has held senior management positions with leading pharmaceutical, consumer products, and engineering consulting companies. His experience includes comprehensive process design in bulk pharmaceutical chemicals manufacturing, biotechnology manufacturing, pharmaceutical solid dosage manufacturing, and containment of potent and radioactive therapeutics. He is also experienced with facility development for therapeutic products operations. Dr. Amer is a recognized expert in GMP compliance and validation.
  • Nuala Calnan, Adjunct Research Fellow, 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.
  • Cliff Campbell, Owner, Cliff Campbell Consulting Ltd

    Cliff Campbell, B.E. is an independent consultant focused on optimising all aspects of 3-Stage PV. He has been an advocate of right-first-time compliance for many years, promoting a back to basics approach to the specification and verification of systems and processes, for both commercial and clinical supply. He has exceptional Agency credentials, having published with both FDA and HPRA on the topics of validation and process criticality. He consults globally in support of PV implementation and related control strategies.
  • Mag Corduff. QA & Compliance Specialist, Odyssey Validation Compliance

    Ms. Corduff is a Quality Assurance and Compliance Specialist with Odyssey Validation Compliance with 15+ years’ experience in QC, QA & Regulatory Compliance across medical device, pharmaceutical and biotechnology industries. Ms. Corduff holds a BSc. Honours in Industrial Microbiology from University College Dublin and an MSc. Pharmaceutical Quality Assurance & Regulation from Dublin Institute of Technology.
  • Parsa Famili, President & CEO, Novatek International

    Mr. Famili is the President and CEO of Novatekinternational (www.ntint.com). Established in 1996, with headquarters in Montreal and offices in India, US and others around the globe, Novatek provides, process-driven software solutions that target the pharmaceutical, biotech and other health-care industries. Cognistat (www.cognistat.com) a subsidiary of Novatek caters to medical industry in the space of Brain Cognitive Impairment. Cognistat makes reliable, precise and rapid assessment tools for detecting Dementia, Concussion and Traumatic Brain Injury. Mr. Famili has published several articles and chapters in various scientific journals and books sharing his more than 25 years of experience with the industry.
  • Norman Fraley, Executive Director, Frolich Institute

    Norman Fraley is the Executive Director of the Frölich Institute for Research in Sustainable Technology. After spending a year in Ethiopia, Norman became an advocate for the creation of robust and durable analytical tools that could be used in developing countries where resources and power were unreliable at best. This led to the formation of a non-profit Institute formed two years ago here in Winston-Salem. Mr. Fraley has spent the past thirty years in the field of Analytical Chemistry and serves as co-lead faculty for the Science of Sustainability at Wake Forest University’s Sustainability Graduate program focusing on Biomass and Bioenergy.
  • Katherine Giacoletti, Partner, SynoloStats

    Katherine has worked as a statistician in the Pharmaceutical industry for over 17 years and has expertise across the product lifecycle, from product and process development through validation and commercial supply, as well as all stages of clinical development from First in Human through licensure and beyond. She holds a Master of Statistics from North Carolina State University, with a focus in biostatistics. Katherine lives and works in the Philadelphia suburbs with her husband and daughter and 2 cats, and in her spare time is a dancer and a teacher of Scottish dancing.
  • JR Humbert, Head/Director, Technical and Validation Standards, Genentech

    Mr. Humbert is an experienced team leader with over sixteen years of experience in all areas of validation including: cleaning validation, process validation, equipment/facilities/utilities qualification, process automation, CSV and 21 CFR Part 11, and analytical test method validation. He has worked as a consultant for both pharmaceutical and biotechnology companies, and has also worked in validation / quality assurance in API, biologics, finished product, and medical device facilities worldwide. He has a Bachelor’s Degree in Chemistry and Biochemistry from the University of Colorado-Boulder, and a MBA from Indiana University.
  • Philip Jarvis, Validation Manager, Alcon, Co. Cork

    Phil 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.
  • Lou Killian, Director Customer Education and Success, Kneat Software

    Lou Killian has extensive LifeScience leadership experience in Quality, Operations, Engineering Services, Regulatory, Business Systems with Abbott, Genentech, BioMarin. Lou’s passion is applying technology to meet business process needs. His current role is Director Customer Education & Success with Kneat Software.
  • Matthew LaPierre, Data Integrity Program Manager, Ipsen Bioscience

    Mr. LaPierre is an experienced data integrity project manager, successfully implementing an effective program at Ipsen Bioscience. He has a thorough understanding of not only the foundation and principles of data integrity but the project management tools and resources needed to execute a truly effective data integrity program at a pharmaceutical site. He is currently working to implement similar programs across global Ipsen.
  • Imelda Mason, IT Manager, Odyssey Validation Compliance

    Imelda Mason is a senior IT professional with over 15 years’ experience of high volume enterprise level IT. Imelda has significant international experience in IT delivery and operations, IT service management, business planning, financial analysis, sourcing and programme management. Imelda has the breadth and depth of experience to bring thought-leadership to any IT transformation programme.
  • Tracy Moore, GMDP Operations Manager and Senior Inspector, Inspection Enforcement & Standards Division, 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.
  • 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 (upstream/downstream production and fill finish), process automated systems, and sterilization/cleaning support systems at pilot plant and full commercial scales. 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.
  • Donncadh Nagle, Validation Coordinator, Avara

    Donncadh has over 19 years’ experience in Validation, Project Management, Mechanical and Manufacturing Engineering (inc. Equipment Commissioning, Qualification and Process Validation) working within the Electronics, Medical Device and Pharmaceutical industries.
  • Kevin O’Donnell, Ph.D., Market Compliance Manager, HPRA

    Kevin is Market Compliance Manager at the Health Products Regulatory Authority (HPRA, formerly known as the IMB). He is responsible for a number of compliance-related and market-surveillance programs at HPRA, such as the quality defect and recall program and its sampling and analysis activities. Kevin is also a senior GMP Inspector at the HPRA. He obtained his PhD in the field of Quality Risk Management from the Dublin Institute of Technology, Ireland, in 2008.
  • Dhruvin Patel, Manager, Change Control & Documentation, Allergan

    Mr. Patel is an experienced team leader with over ten years of experience in process validation, method validation, CSV, GAMP 5, and 21 CFR Part 11. He has successfully managed transitions from paper to electronic systems as well as implementation of risk-based approaches to improve system utilization. He is an ASQ Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), and a Lean Six Sigma Green Belt.
  • Rashida Ray, President, Array Validation Quality and Compliance (AVQC), Inc.

    Rashida Ray is the founder and president and of Array Validation Quality and Compliance (AVQC) Inc., which has been providing compliance and validation services to pharmaceutical, medical device and biotechnology industries since 2004. She is an experienced consultant with twenty years of experience working in in in all areas of validation and traveled the world on numerous validation/compliance engagements including 6 consent decree sites. For the past 17 years she has concentrated her expertise in the area of computer systems validation. She is also fluent in French and Portuguese languages.
  • Alice Redmond, Vice President, Europe Operations, CAI

    Alice Redmond, PhD is Vice President, Europe Operations at Commissioning Agents, Inc. 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 Basel, Kundl and Ireland 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. Alice has significant large global project experience of green field facilities including fill finish, biotech, gene therapy, medical devices, small and large molecule API and OSD from design through to operational readiness. She has presented projects internationally to numerous regulatory agencies and has facilitated many clients to PAI readiness or remediation. Alice regularly presents for ISPE, PDA and RAPS and was recently awarded a lifetime achievement award for PDA Europe. She is a former winner of the ISPE Robert F. Sherwood Article of the Year Award. She was a committee member on the Biotech and Disposables CoPs and Lead on the Knowledge Assets Committee. Alice currently serves on the ISPE C&Q CoP Steering Committee and is a former co-chair of this committee. She is on the ISPE Commissioning and Qualification Baseline® Guide Revision Team and serves as a training instructor in QRM for ISPE and collaborative ISPE and NIBRT training. Alice participated in the inaugural Women in Pharma forum at ISPE Annual Meeting 2016. Alice holds a PhD in Cell Culture from Dublin City University, an MBS in Project Management from University of Limerick and a Degree in Biotechnology from Dublin City University.
  • 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.
  • Tara Scherder, Partner, SynoloStats

    Tara Scherder has over 25 years of experience in the chemical and pharmaceutical industries as a statistician, process engineer, and master black belt. She has functioned as both an in-house and external statistical consultant to drug substance and drug product teams across the product lifecycle for the spectrum of product platforms. As partner at SynoloStats, she passionately shares the opportunity for patient and business benefit through the powerful combination of statistics and process.
  • Steve Thompson, Senior Manager, Professional Services, ValGenesis, Inc. – South San Francisco, CA

    Steve has over 20 years of GxP experience in Life Sciences (including Medical Device), is a Parenteral Drug Association (PDA) certified Auditor, has held managerial positions at various levels within Information Technology (IT) and Quality Assurance (QA) for major organizations, is a published author, and has presented at several conferences and industry associations. Steve has a B.S. in Computer Information Systems from DeVry University, City of Industry, California.
  • Mark Thompson, Managing Director, Mark Thompson Life Sciences Ltd.

    Mark Thompson is a Chartered Engineer with nearly 30 years experience in the Life science industries. Following senior engineering, project and management roles at Eli Lilly, Sanofi Aventis and Smith & Nephew, Mark started offering external support to Industry in 2000 and has been involved in providing Project, Consultancy and Training Support ever since. Mark has worked all over the world with hundreds of organisations, delivering training to thousands of people. This has included delivering training courses for regulatory inspectors from China, Saudi, UK, Ireland, Italy, Denmark and the Netherlands.Mark is constantly involved in projects and Regulatory support ensuring that the information presented is up to date with current technology, industry practice and regulatory expectations.
  • David Vincent, Ph.D 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.
  • Robert Wherry, 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, in Lexington, Massachusetts.
  • Chris Wubbolt, Principal Consultant, QACV Consulting, LLC

    Mr. Wubbolt has provided Quality Assurance and Compliance consulting services since 2001, focusing on Quality Assurance, data integrity, audits, training, and validation projects. Chris is a prolific speaker on various topics at industry conferences and for different groups, such as SQA and IVT. Mr. Wubbolt was previously President of NERCSQA and MARSQA and remains active in both organizations. He is also co-chair of the MARSQA Computer Validation Committee. Mr. 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. Chris worked at Lancaster Laboratories, Johnson & Johnson, Aventis, and Hoffmann-LaRoche prior to starting his career in consulting. He remains active in various industry groups and was a contributing member of the DIA’s “Peach Report” (Computerized Systems used in Clinical Research” as well as the original GAMP Guide on validation of laboratory systems.
  • Joseph Zec, Associate Director, CSV and Compliance, Shire plc

    Joe is currently Shire’s Computer System Validation Lead, R&D. He and his team define and execute software development and validation strategy and policy, and monitor its effectiveness. He has over 35 years of experience in the software industry and is trained as a CMM Assessor. Most of his career has been spent in the areas of software testing and software quality assurance. He has worked in many industries, including financial services, semi-conductor test equipment, telecommunications, commercial meteorology, avionics, and life sciences. He has presented and chaired at numerous conferences, both domestically and internationally. A native of Massachusetts, Joe received his BA in Economics from Harvard University.

Sponsors

  • GOLD


  • Ellab



    Providing the world's leading life science and food companies with high quality thermal process validation and monitoring solutions
    Website: http://www.ellab.com
  • Kneat Software



    Digitally Transforming GxP Validation Processes
    Website: http://kneat.com
  • ValGenesis

    Global Leader in Paperless Validation
    Website: http://www.valgenesis.com/
  • SILVER


  • Mark Thompson Life Sciences








    Consultancy and Training that Delivers a Measurable Return on Investment.
    Website: http://markthompsonls.com/
  • Novatek



    Novatek International provides a new breed of all-encompassing, process-driven LIMS and other software solutions that target the pharmaceutical, biotech and other health-care industries.
    Website: http://ntint.com/
  • SynoloStats

    We have expertise in the practical implementation of a wide range of statistical methodologies in all parts of the pharmaceutical product lifecycle.
    Website: http://www.synolostats.com
  • VTI Life Sciences

    Inspiring Operational Excellence through Best-in-Class CQV Processes
    Website: http://validation.org/

Partners

  • Dublin Institute of Technology

    At Dublin Institute of Technology, innovation is our tradition, and we have produced generations of leaders in a range of fields from science and health; business; law; social sciences; tourism & hospitality; the creative & visual arts to engineering & the built environment. Our lively City-Centre campuses, including our new research and innovation hub at Grangegorman, are home to more than 20,000 students from Ireland and abroad, creating a culturally diverse and stimulating learning and research environment.
    Website: http://www.dit.ie/
  • American Pharmaceutical Review

    In-depth coverage of the latest GXP developments



    Website: http://www.americanpharmaceuticalreview.com/
  • BioIT World

    Bio-IT World provides outstanding coverage of cutting-edge trends and technologies that impact the management and analysis of life sciences data, including next-generation sequencing, drug discovery, predictive and systems biology, informatics tools and personalized medicine.
    Website: http://www.bio-itworld.com/
  • Pharmaceutical Outsourcing

    Addressing up-to-the-minute manufacturing challenges
    Website: http://www.pharmoutsourcing.com/

Venue

Details

Start:
November 19
End:
November 21
Event Category:

Venue

Dublin
Dublin, Ireland + Google Map

Pricing & Registration

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