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CLEANING VALIDATION & CRITICAL CLEANING PROCESSES

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November 25 - November 27

Cork, Ireland

Design a Cleaning Program that Impresses Regulatory Investigators

 

A compliant cleaning validation program is essential for a successful regulatory inspection. Even today, many have struggled to develop effective processes and keep up with evolving sterile regulations that meet an inspector’s expectations. This conference is designed for those professionals in charge of developing, implementing and maintaining new or legacy cleaning validation programs. Attend this conference and walk away with the innovative processes, techniques and tools that have an immediate impact for your company and professional development.

 

Top 10 Reasons to Attend:

  1. Overcome the Top Five Cleaning Validation Challenges
  2. Understand EU Annex 1 Revisions – Your Guide to Sterile Manufacturing
  3. Implement a Risk-Based Cleaning Validation – Key Elements to a Successful Program
  4. Establish Acceptance Criteria and Health-Based Limits in Cleaning Validation
  5. Create Best-in-Class Cleaning Validation Documents – Master Plans, SOPs, Assessments, Technical Reports and More
  6. Develop Cleanroom Validation, Disinfection and Environmental Monitoring Procedures
  7. Manage Changes in Cleaning Validation Processes
  8. Use Advanced Analytical Methods for Cleaning Validation
  9. Set Critical Cleaning Process Parameters and Critical Quality Attributes
  10. Qualify Water Systems, Clean Steam Systems and Process Gasses

 

Personnel in the Following Environments Should Attend:

  • Validation
  • QA/QC
  • Engineering
  • Regulatory Affairs
  • Compliance
  • 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 and Tea
  • 13:15
    Chairperson’s Welcome and Opening Remarks
  • 13:30
    Ensure Your Validation, QRM and DI Programmes are Fit-for-Purpose
    Nuala Calnan, Ph.D, Founder & Principal, BioPharm Excel Ltd.; Researcher, Technological University Dublin
  • 14:00
    Managing a Data Integrity Programme – Essential Tips for Success
    Matthew LaPierre, Specialist – CSV and Data Integrity Compliance
  • 14:30
    Prepare for Validation Inspections and Respond to Regulatory Findings
    Milan Kalinic, Validation Lead, Alexion Pharmaceuticals
  • 15:00
    Networking Refreshment Break
  • 15:30
    Managing a Data Integrity Programme – Essential Tips for Success
    Matthew LaPierre, Specialist – CSV and Data Integrity Compliance
  • 16:00
    Overcome the Top Five Validation Challenges
    Connie Hetzler, Global Head – Validation, Alcon Laboratories
  • 16:30
    Acquire a Systematic Approach for a Knowledge Management Model
    Cliff Campbell B.E., Principal, Cliff Campbell Consulting Ltd.
  • 17:15
    Networking & Welcome Reception
  • 7:00
    Coffee and Lite Breakfast
  • 7:30 - 8:15
    Select Between Knowledge Exchange Sessions (1- 4)
  • 1
    Change Control in Validation – Managing Like-for-Like Changes
    Donncadh Nagle, Validation Coordinator, Avara Shannon, Alma O’Reilly, Validation Manager, LEO Pharma,Researchers,Technological University Dublin
  • 2
    Build an Effective Medical Device Single Audit Programme
    David W.Vincent, Ph.D., CEO,VTI Life Sciences
  • 3
    Compliance Intelligence – Stay Up to Speed with FDA's Proposed Computer Software Assurance Draft Guidance
    Chinmoy Roy, Senior Industry Consultant, VALGENESIS
  • 4
    Data Integrity – Navigating the Maze of Regulations
    David W. Vincent, MPH, Ph.D., CEO, VTI Life Sciences
  • 8:30 - 10:00
    Select Between Best-In-Class Case Studies (5-8)
  • 5
    The Validation Master Plan (VMP) – Plans that Impress Investigators
    Connie Hetzler, Global Head – Validation, Alcon Laboratories
  • 6
    Risk-Based Cleaning Validation – Key Elements to a Successful Programme
    Fergal Giles, Cleaning Validation Lead, Janssen Sciences Ireland
  • 7
    Introduction to Validation Statistics for Non-Statisticians
    Raul Soto, Senior Principal Software Engineer, Johnson & Johnson Vision Care
  • 8
    Implement an Effective and Pragmatic Data Integrity Programme
    Chris Reid, Managing Director, Integrity Solutions, Inc.
  • 10:00
    Networking Refreshment Break
  • 10:30 - 12:00
    Select Between Knowledge Exchange Sessions (9-12)
  • 9
    Successful Implementation of a 3-Stage Process Validation Programme
    David W. Vincent, Ph.D., CEO, VTI Life Sciences
  • 10
    Establish Acceptance Criteria and Health-Based Limits in Cleaning Validation
    Joe Brady, Lecturer, School of Chemical and Pharmaceutical Sciences
  • 11
    Implement a Risk-Based Computer Systems Validation Programme
    Chris Reid, Managing Director, Integrity Solutions, Inc.
  • 12
    Impact of Human Factors on Data Integrity
    Matthew LaPierre, Specialist – CSV and Data Integrity Compliance
  • 12:00
    Poster Session & Networking Luncheon
  • 13:15 - 14:45
    Select Between Knowledge Exchange Sessions (13-16)
  • 13
    Key Considerations for Process Validation and Successful Tech Transfer
    Derek Foley, Senior Validation Engineer, Janssen Sciences Ireland
  • 14
    Effective Continuous Cleaning Process Verification – Key Elements to a Successful Programme
    Sunil Patel, Senior Global Technical Leader, Ecolab Life Sciences
  • 15
    Implementation of a Risk-based Verification Strategy for CQV
    Alice Redmond, Vice President European Operations, Commissioning Agents Inc.
  • 16
    Data Integrity Risk Assessments – Using Process Flow Charts
    Chinmoy Roy, Industry Consultant, ValGenesis Inc.
  • 14:45
    Afternoon Refreshment Break
  • 15:15 - 16:45
    Select Between Knowledge Exchange Sessions (17-20)
  • 17
    Improper Use of Statistics – The Misuse, Misinterpretation and Bias of Analytical Assay Data
    Douglas B. Brown, Ph.D., Senior Scientist, Methods Development and Validations, Charles River Laboratories, Inc.
  • 18
    Implement and Validate Single Use Systems (SUSs) in Biopharmaceutical Manufacturing
    Aidan Sexton, Process Validation Support Lead, Janssen Sciences Ireland
  • 19
    Validation of Mobile Applications
    Raul Soto, Senior Principal Software Engineer, Johnson & Johnson Vision Care
  • 20
    Data Integrity Master Class
    Rashida Ray, President, Array Validation Quality and Compliance (AVQC), Inc.
  • 16:45
    Validating Cloud Solutions – Learn How to Mitigate Risk
    Michal Timler, Senior Validation Consultant, ecvalidation
  • 7:00
    Coffee and Lite Breakfast
  • 7:30 - 8:15
    Select Between Knowledge Exchange Breakfasts (21-24)
  • 22
    Latest Developments in the Qualification of Water Systems, Clean Steam Systems and Process Gasses
    Mark Thompson, Managing Director, Mark Thompson Life Sciences Ltd.
  • 23
    Conduct Risk-Based Revalidations and Periodic Reviews of Systems
    Donncadh Nagle, Validation Coordinator, Avara Shannon Researcher, Technological University Dublin
  • 24
    Learn How to Use Testing as a Risk Mitigation Tool
    Kamila Sitkiewicz, Senior Validation Consultant, ecvalidation
  • 8:30 - 10:00
    Select Between Knowledge Exchange Sessions (25-28)
  • 25
    Continued Process Verification (CPV) – Maintain the Validation State
    Philip Jarvis, Global C&Q, Abbvie
  • 26
    Development and Qualification of Vapour Phase Hydrogen Peroxide for Decontamination & Sterilisation
    Mark Thompson, Managing Director, Mark Thompson Life Sciences Ltd.
  • 27
    Improper Use of Statistics – The Misuse, Misinterpretation and Bias of Analytical Assay Data
    Douglas B. Brown, Ph.D., Senior Scientist, Methods Development and Validations, Charles River Laboratories, Inc.
  • 28
    Qualification and Data Integrity Strategies for IT Infrastructures
    Oisín Curran, CEO, CompliantCloud.com
  • 10:00
    Mid-Morning Refreshment Break
  • 10:30 - 12:00
    Select Between Knowledge Exchange Sessions (29-32)
  • 29
    Data Contextualization, Modelling (Multi Variate Analysis) and Advanced Process Control
    Patrick T. O’Sullivan Multivariate Analysis Lead, Janssen Sciences Ireland
  • 30
    Critical Cleaning Process Parameters and Critical Quality Attributes
    Philip Jarvis, Global C&Q, Abbvie
  • 31
    The Use of Wireless Dataloggers for Thermal Validation
    Chris Maughan, Managing Director, Thermal Compliance Ltd.
  • 32
    Conducting an Audit and Gap Analysis of Computerised Systems
    Matthew LaPierre, Specialist – CSV and Data Intvegrity Compliance
  • 12:00
    Networking Luncheon
  • Case Study: Haze Formation and Resolving the Problem in Sterile Form, Fill, and Finish Lines
    Sunil Patel, Senior Global Technical Leader, Ecolab Life Sciences
  • Documentation Requirements for Successful Validation
    Chinmoy Roy, Senior Industry Consultant, VALGENESIS
  • 13:00 - 14:30
    Select Between Knowledge Exchange Sessions (33-35)
  • 33
    Equipment Qualification – Fit for Intended Use
    Milan Kalinic, Validation Lead, Alexion Pharmaceuticals
  • 34
    Cleanroom Validation, Disinfection and Environmental Monitoring
    To Be Announced
  • 35
    Machine Learning (ML) Validation and the Future of CSV
    Rosalind Beasley, Digital Transformation Leader, ROQMetrics, Inc.
  • 14:30
    Afternoon Refreshment Break
  • 15:00 - 16:30
    Select Between Knowledge Exchange Sessions (36-37)
  • 36
    Statistical Process Controls – Construct and Analyze Control Charts
    Raul Soto, Senior Principal Software Engineer, Johnson & Johnson Vision Care
  • 37
    Overcome the Challenges of MS Excel Spreadsheet Validation
    Overcome the Challenges of MS Excel Spreadsheet Validation
  • 16:30
    Close of Conference

Faculty

  • Rosalind Beasley, Digital Transformation Leader, Healthcare & Life Sciences, ROQMetrics, Inc.

    Mrs. Beasley is a senior executive with over 20 years of experience focused on digital transformation within highly regulated industries such as pharmaceuticals, medical devices, and consumer packaged goods. With in-depth knowledge of quality and regulatory processes and best practices, Mrs. Beasley helps companies maximize their investment in enterprise cloud GxP solutions. In 2011, Mrs. Beasley co-founded 123Compliance (acquired by Sparta Systems) and introduced one of the first multitenant cloud-based complaint management, quality management, document management, and training solutions to the life sciences industries.
  • 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.
  • Nicola Brady, QA & Compliance Specialist, Odyssey Validation Compliance Limited

    Nicola Brady is QA & Compliance Specialist at Odyssey VC Limited and is responsible for the Quality and Compliance aspects of the organisation. Nicola has responsibility for the maintenance and management of the Odyssey VC Quality Management System in accordance with ISO 9001:2015 as well as providing QA & Compliance oversight for integrated GxP computer systems lifecycle management and qualified infrastructure delivered through www.compliantcloud.com, powered by Odyssey VC. Nicola started her professional life as a Quality Control analyst working in the life science sector before moving into Quality Assurance roles of increasing responsibility where she was involved in Quality Management System maintenance, Quality Risk Management as well as Validation and Qualification oversight for capital projects, new product introductions and technology transfers. Odyssey VC is one of the first companies in the world with the capability to deliver end to end IT Compliance to the Life Science sector and other healthcare markets. Nicola brings 16 years of QA and Compliance experience to her role within Odyssey VC enhancing the organisation’s ability to focus its efforts ‘where IT meets compliance’ and help organisations move compliant applications and data to the cloud in an ‘audit-ready’ state.
  • Douglas B. Brown, Ph.D., Senior Scientist, Charles River Laboratories, Inc.

    Douglas B. Brown, Ph.D. is a Sr. Scientist at Charles River Laboratories, Biologics Testing Solutions Division. For over 15 years, he had been a lead scientist for the development of molecular-based assays utilized in the detection and identification of viruses, bacteria, residual host-cell DNA, and other contaminating agents which may be transferred during a manufacturing purification process. Throughout the last 10 years, Dr. Brown has also been focusing his efforts on process and efficiency improvement within the GMP environment as well as developing, improving, and optimizing test method verification, qualification, and validation processes and procedures.
  • Dr. Nuala Calnan, Founder & Principal, BioPharm Excel Ltd., Adjunct Research Fellow, Technological University Dublin

    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.
  • Oisín Curran, CEO, CompliantCloud.com

    Mr. Curran is an experienced consultant in the area of regulated computerised systems and associated infrastructure. He has a significant track record in delivering compliant applications and data on behalf of Fortune 500 companies globally. In creating Compliantcloud.com he has been at the forefront of delivering innovative and future proofed Compliant IT solutions such as:
  • Parsa Famili, MSc, President & CEO, Novatek International

    Parsa Famili, MSc. is the President and CEO of Novatek International. Prior to joining Novatek, he held senior management positions in quality departments of Several North American pharmaceutical companies. He has participated and successfully completed several FDA, EMEA, TGA, and Health Canada audits. He was also an instructor of Chemistry and Bio-Chemistry at Vanier College in Montreal, Quebec Canada. Mr. Famili has published several chapters and articles in various industry journals and publications. His latest contribution “User Requirements and Implementation of a Risk-Based, Compliant Stability Management System” in Methods for Stability Testing of Pharmaceuticals (edited by Edited by Bajaj, Sanjay, Singh, Saranjit, 2018). He is also an international speaker at ISPE, PDA, IVT, IPA, KENX, EXPOFARMA, and CBI along with many other industry associations.
  • Derek Foley, Senior Validation Engineer, Technical Operations, Janssen Sciences Ireland

    Mr. Foley is an experienced Engineer with over twenty years of experience in FDA/EMEA regulated biopharmaceutical, pharmaceutical and medical device industries. Derek has extensive experience in many areas of validation including; Process Validation, Cleaning Validation, CSV, Analytical validation and Validation of equipment/automated processes.
  • Fergal Giles, Technical Operations - Cleaning Validation Lead, Janssen Sciences Ireland

    Mr. Giles is an experienced validation lead with over fifteen years of experience in validation particularly cleaning validation. He has successfully completed complex validation projects within the biopharmaceutical industry.
  • Connie Hetzler, Global Head of Validation, Alcon Laboratories

    Ms. Hetzler has over 32 years of experience working in regulated consumer products and healthcare industry roles. In her current role as Global Head of Validation for Alcon, she is accountable for the validation strategy for 16 manufacturing sites including both the surgical and vision care divisions.
  • Philip Jarvis, EU C&Q lead, Abbvie

    Mr. Jarvis is an experienced team leader with over 15 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 ,and currently is the European lead for C&Q for Abbie .
  • Milan Kilanic, Validation Lead, Alexion Pharmaceuticals

    Milan Kalinic is Pharmaceutical professional specializing in Sterile Fill Finish and Solid Dosage manufacturing environment with more than 13 years of experience. Currently works as a Validation Lead at Alexion Pharmaceuticals. Previous position includes Validation Specialist at Hemofarm (Member of STADA Arzneimittel Group). Milan was responsible for Leading of cross functional CQV Teams and manufacturing equipment projects delivery within the Hemofarm Group such as: Start-up of the Syringes & Cartridges Manufacturing Site, Start-up of the Ampoules Manufacturing Site and Start-up of the Sterile Nasal Spray Manufacturing Site. Also, he was responsible for leading a Packaging Lines CQV team for start-up of Packaging Center for Solid Dosages Forms. Milan is manufacturing specialist for Filling Lines (CIP/SIP and Isolators), Compounding Systems, Autoclaves, Freeze Dryers, HVAC, Water Systems and Systems for Pharmaceutical Gases.
  • Matthew LaPierre, Industry Expert

    Mr. LaPierre is an industry expert and an experienced data integrity project manager. He has a thorough understanding of not only the foundation and principles of data integrity but also the project management tools and resources needed to execute a truly effective data integrity program in the life science industry.
  • Chris Maughan, Managing Director, Thermal Compliance Ltd

    Chris is the Managing Director of Thermal Compliance Ltd, who specialize in the qualification of Thermal Systems. With over 15 years of hands-on validation experience in the Thermal and Biological Validation of Sterilization processes alongside temperature, humidity and CO2 mapping of Controlled Temperature Units. Chris has a detailed knowledge of validation systems and the use of wireless dataloggers, for the Qualification of Thermal Systems.
  • Graham Miller, Global Channel Development Manager Molecular Spectroscopy PLMA Solutions Unit, Agilent Technologies

    Graham Miller has over thirty of experience working in the field of analytical instrumentation including fifteen years in the field of Mobile and handheld FTIR spectroscopy. He played a role when they the first commercial platforms were launched in the mid noughties. In his current position, with Agilent Technologies, he works in business development and helps to define the strategic direction for its mobile FTIR product line and most recently has been working with the pharmaceutical industry on the topic of Rapid Cleaning Verification.
  • Donncadh J. Nagle, Principle Validation Engineer, Avara Pharmaceuticals Shannon

    Donncadh Nagle is a pharmaceutical industry professional based in Ireland and is a recent graduate from the masters degree programme, MSc. in Pharmaceutical Validation Technology, at the Technological University Dublin (TU Dublin). Donncadh is an experienced Validation Engineer with over eleven years of experience in all areas of validation including; Process/Product Validation, Equipment/Automation Qualification, Facilities Qualification, Computer System Validation, Test Method Validation, and Cleaning Validation. Through strategic thinking, he has success in steering and managing complex validation projects within the medical device and pharmaceutical industries. Donncadh has ambitions to become an industry leader within the pharmaceutical industry and is the current Chair of the BPCI Validation group, Ireland. Donncadh is also a recent winner of the 2018 Thesis award presented by KENX at their C&Q and Data Integrity conference, in Dublin, Ireland. Donncadh is also a published author with IVT/JVT, USA
  • Cormac O'Leary, IT & Compliance Specialist, Odyssey Validation Compliance Limited

    Cormac O'Leary is IT & Compliance Specialist at Odyssey VC Limited and is responsible for the IT and Compliance aspects of the organisation. Cormac assists colleagues and customers in the delivery of compliant IT solutions. Odyssey VC is one of the first companies in the world with the capability to deliver end to end IT Compliance to the Life Science sector and other healthcare markets. Cormac has responsibility for the maintenance and management of the Odyssey VC’s IT systems (GxP and Non-GxP) and customer offerings hosted in CompliantCloud.com, a qualified infrastructure product power by Odyssey VC. Cormac started his professional life as automation engineer for one of the world’s largest microprocessor manufacturers. He then progressed into roles including Senior software engineer and Technical Team Lead for Level 2 and Level 3 support. From there he moved into ITOps/DevOps for GxP Solutions, for a global multinational information technology leader. Cormac brings a wealth of IT knowledge, whilst understanding compliance requirements relevant to GxP regulated companies, to his role within Odyssey VC ’s enhancing the organisation’s ability to focus its efforts ‘where IT meets compliance’ and helping organisations move compliant applications and data to the cloud in an ‘audit-ready’ state.
  • Alma O'Reilly, Researcher at TU Dublin and Validation Manager at LEO Pharma Dublin

    Alma O’Reilly is LEO Pharma Dublin’s Validation Manager and she is a researcher at the Technological University Dublin (TU Dublin). Alma has over 20 years’ experience in the pharmaceutical industry. In that time she has she has worked in API, Bulk Process, Fill Finish and Packing Operations. She has extensive experience with automation systems, EBR, serialisation, energy, clean utilities, CSV and more recently with equipment, cleaning and process validation. She is currently heading up LEO Pharma’s drive to standardise validation systems and procedures across the group including 5 manufacturing sites. She holds an honours degree in Mechanical Engineering, and is currently studying for a Master’s degree in Validation with TU.
  • Patrick T. O’Sullivan, Technical Operations, Janssen Sciences Ireland UC

    Patrick has been working in the area of Multivariate Analysis across Janssen’s Large & Small Molecule platforms with responsibility for Multivariate Analysis on the Cork sites. He continues to be an active member in the academic community guest lecturing on the area of advanced analytics and its place in the pharmaceutical and biopharmaceutical sector both today and in the future to Biotechnology & Data Analytics students.
  • Sunil Patel, Senior Global Technical Leader, Ecolab Life Sciences

    Sunil has over 13 years of experience working in the engineering and validation fields of cGMP / FDA / EU / ISO regulated industry sectors. Sunil has a strong background in Cleaning Validation (CIP, COP, Manual), Process Validation, Process Design, Clean Utilities (WFI, PW, Clean Steam, Clean Air, Clean Gases), HVAC, Project Management, Sterilization and Processing Equipment Validation. Further expertise includes Process Optimization/Improvement, Regulatory Compliance and Risk Management methodologies for the pharmaceutical and biologics industry.
  • 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 quality assurance, compliance and validation services to pharmaceutical, medical device and biotechnology industries since 2004. She is an experienced consultant with over twenty years of experience working in all areas of validation, compliance, quality assurance and has traveled the world on numerous engagements in those areas, 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.
  • Chris Reid, CEO, Integrity Solutions Limited

    Mr. Reid has 25 years of experience in all areas of GxP quality and is the current Global Chair of ISPE GAMP where he supports the implementation of risk-based guidance and education. Reid has significant experience of leading global quality programs including Data Integrity, Quality Organization development, Quality Systems implementation and CSV.
  • Chinmoy Roy, Industry Consultant, ValGenesis Inc

    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.
  • Aidan Sexton, Technical Operations, Janssen Sciences Ireland UC

    Dr. Sexton is an experienced team leader with over twenty years of experience in all areas of validation including; process validation, facilities validation, analytical equipment, and cleaning validation. He has been active in leading intricate projects within the sterile fill finish, API and biopharmaceutical industry.
  • Kamila Sitkiewicz, Senior Validation Consultant, ecvalidation

    More than 8 years of experience in Validation and IT Systems Implementation (4 years in LIMS implementation, 4 years in CSV). Responsible for ERP-class systems, Supply Network Collaboration and Batch Tracing. Recently supporting Data Exchange System based on Cloud Solution.
  • Raul Soto, MSc, CQE, Senior Principal Engineer, Johnson & Johnson Vision Care

    Raul Soto is a Senior Principal Software Engineer at Johnson & Johnson Vision Care (JJVC), focused on Computerized Systems Validation and Software Quality Engineering. Mr. Soto has over 20 years of experience in validation, process engineering, industrial automation, and software quality; and has held positions of increasing responsibilities in the medical devices, biotechnology, pharmaceutical, and consumer electronics industries. Raul has led multiple global and site projects in the United States, Europe and China. As an invited speaker he has lectured on computer systems validation, data integrity, statistics, PLC/SCADA automation, and quality/compliance issues at various conferences in the United States and Europe. Raul has an MS degree in Biotechnology with emphasis on Biomedical Engineering, and a BS degree in Mechanical Engineering. He is also an ASQ Certified Quality Engineer (CQE).
  • Michał Timler, Senior Validation Consultant, ecvalidation

    More than 11 years of experience in Validation and Qualification (6 years in technical qualification, 5 years in CSV). Responsible for ERP-class systems, Supply Network Collaboration and Batch Tracing. Recently supporting Cloud Serialization Solution.
  • 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.

Sponsors


  • Fundamentally we exist for one reason: To accelerate our clients’ path to success. Our approach is simple; we put the client’s interests first. We don’t stop until it’s right. And we’ll do whatever it takes to get there.
    Website: https://commissioningagents.com
  • ecvalidation is a division of eConsulting company. We offer validation and qualification services of software, equipment, installations, rooms and processes. Our advantages are skills, knowledge and the qualifications of our team members. We have gathered vast experience through over 300 projects for clients from industries where quality assurance is of key importance. We also put a great emphasis on broadening our knowledge on new regulations, recommendations and best practices.
    Website: www.econsulting.pl

  • Ecolab is the global leader in water, hygiene and energy technologies and services. Every day, we help make the world cleaner, safer and healthier – protecting people and vital resources.
    Website: https://www.ecolab.com/
  • For almost sixty years, Kaye has been at the forefront of high accuracy process measurement. For applications from thermal process validation and environmental monitoring, to sensor calibration, Kaye technology has provided the most accurate and user friendly measuring systems available in the market today.
    Website: https://www.kayeinstruments.com/en/
  • Consultancy and Training that Delivers a Measurable Return on Investment.
    Website: http://markthompsonls.com/
  • ROQMetrics is a Life Sciences CSV solutions and consulting firm with over 20 years of experience in global GxP compliance and technology. We offer innovative SaaS solutions to accelerate and elevate compliance of GxP applications using proven frameworks and methodologies. ROQMetrics helps with all aspects of validating computer systems from developing IT processes, SOPs, validation plans, risk assessment, test scripts, etc. ROQMetrics uses Lean-Agile practices to bring collaboration, continuous feedback, and improvement to the application lifecycle, resulting in more responsive and adaptive processes.
    Website: https://roqmetrics.com/

  • AVQC, Array Validation Quality & Compliance, Inc. is a Multinational Life Sciences Global Compliance Consulting Firm with 25 + years experience delivering Technical Writing and Validation Services in the Pharmaceutical, Medical Device, Biotechnology and Food Industries.
    Website: https://www.avqc.com/
  • Since 1949, Ellab is a leading manufacturer of a full line of wireless, real-time data loggers and wired thermocouple validation systems with temperature, humidity, pressure, vacuum, conductivity and CO2 sensor options. Additionally, Ellab offers temperature standards, calibration dry blocks and liquid baths, custom fittings, accessories, and thermocouples. We also offer on-site qualification, validation and calibration services for thermal validation processes ranging from -196°C to 400°C. Typical environments often include -80°C freezers, incubators, stability chambers, autoclaves, and ovens.
    Website: https://www.ellab.com/
  • Kneat makes validation easier, faster and smarter for Life Sciences. Our purpose-built, paperless validation software digitizes the validation life-cycle from end to end, so you never need to go to paper again.
    Website: http://kneat.com
  • 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. Our unique portfolio of out-of-the-box, easy to use software solutions features specialized modules that help you manage all aspects of your quality environment with less effort and time. Novatek delivers solutions that go beyond LIMS for total enterprise wide automation.
    Website: https://ntint.com/
  • Global Leader in Paperless Validation.
    Website: http://www.valgenesis.com/
  • Inspiring Operational Excellence through Best-in-Class CQV Processes
    Website: http://validation.org/

Partners

    More Information To Follow Soon

Venue

Details

Start:
November 25
End:
November 27
Event Category:

Venue

Rochestown Park Hotel
Rochestown Road
Cork, Ireland
+ Google Map
Phone:
353 21 489 0800
Website:
https://www.rochestownpark.com/

Pricing & Registration

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