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COMPUTER SYSTEMS VALIDATION & DATA INTEGRITY COMPLIANCE CONGRESS

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December 9 - December 11

Philadelphia, United States

Implement Programs that are Compliant, Smart and Progress with Today’s Evolving Technology

 

This fall, FDA plans to release a draft guidance on Computer Software Assurance! Are you prepared? To this day, FDA still issues many Warning Letters emphasizing validation, quality assurance and Data Integrity 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, PA, and showcases the protocols, methodology and actions necessary to avoid regulatory action.

 

Choose from Over 35 Tutorials Addressing Today’s Top Challenges

 

COMPUTER SYSTEMS AND SOFTWARE VALIDATION

  • Develop a Compliant-Winning Strategy to Migrate Electronic Records
  • Implement Process Mapping for IT Infrastructures
  • Learn Machine Learning and AI Validation Techniques
  • Conduct Risk-Based Impact Assessments and Continuous Monitoring
  • Understand Pharma 4.0 and the Impact of Digitalization and IoT to CSV
  • Implement Risk Management in Cloud-Based Exchange Systems
  • Modernize the Periodic Review Process
  • Overcome MS Excel Spreadsheet Validation
  • Validate Cloud-hosted Systems and Network Infrastructures

 

DATA INTEGRITY GOVERNANCE AND INSPECTION READINESS

  • Conduct a Thorough and Accurate Gap Assessment
  • Identify Gaps and Investigate Root Causes of Lapses
  • Construct of a Program from the Ground Up
  • Understand the Impact of Human Performance – Transform the Culture
  • Implement an Effective Audit Trail Review Process
  • Conduct a Risk-based Remediation
  • Implement a CAPA Process – What to Do When Things Go Wrong
  • Manage Corporate Challenges and Define Clear Roles and Responsibilities
  • Learn How to Effectively Document Risks

 

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.

 

Did you know you can receive 1.5 graduate credit hours with Temple University’s RAQA graduate program?

 

 

 

CLICK HERE to learn more about our mutual collaboration.

 

 

Get 1.5 graduate credit hours for two-and-a-half days, 18 instructional hours, and an exam within three weeks of completing the conference.

 

 

Agenda

  • 12:00 PM
    Conference Registration
    Coffee and Lite Snacks On-the-Go
  • 12:45 PM
    Chairperson's Opening Remarks
  • 1:00 PM
    Compliance Intelligence – Stay Up to Speed with FDA’s Proposed Computer Software Assurance Draft Guidance
    Senthil Gurumoorthi, Associate Director, Gilead Sciences; Khaled Moussally, Head of Quality, Compliance Group; Jason Spiegler, Sr. Director, Siemens Digital Industries Software Inc.; Ken Shitamoto, Senior Director, Gilead Sciences; Francisco (Cisco) Vicenty, Consumer Safety Office, CDRH, U.S. FDA
  • 2:30 PM
    Managing a Data Integrity Program – Essential Tips for Success
    Matthew LaPierre, Specialist – CSV and Data Integrity Compliance
  • 3:00 PM
    Networking Refreshment Break
  • 3:30 PM
    Educating Personnel in CSV Execution
    Ed Eirikis, Senior Computer Validation and Compliance Manager, Janssen BioTherapeutics
  • 4:10 PM
    The Interrelationship between 21 CFR Part 11 & Data Integrity Compliance
    William T. Drummond Jr., Director, Global Computer Validation Quality Assurance, Charles River Laboratories
  • 4:40 PM
    Develop a Winning Strategy to Migrate Electronic Systems
    Saurav Ghosh, Consulting Director, NNIT
  • 5:10 PM
    Temple University Scholarship Award & Welcome Reception
  • 7:00 AM
    Coffee and Lite Breakfast
  • 7:30 - 8:15 AM
    Select Between Knowledge Exchange Sessions (1-3)
  • 1
    Manage a Global Network Infrastructure in a Regulated World
    Lelia Scott, Executive Director, Global Quality Systems, Charles River Laboratories
  • 2
    CSV Risk Management 101 – Techniques, Tools, Roles and Documentation
    Kevin Martin, Azzur Group
  • 3
    Data Integrity Practice for Paper-based and Hybrid Systems
    John Hannon, Global Principal for Automation and IT, CAI
  • 8:30 AM - 12:00 PM
    Select Between Execution and Master Planning Workshops (A-C)
  • A
    Implement Risk-based Computer Systems Validation – A Holistic Model
    Senthil Gurumoorthi, MS, MBA, Associate Director, IT, Gilead Sciences; Ken Shitamoto, MS, Senior Director, IT, Gilead Sciences
  • B
    Machine Learning (ML) Validation and the future of Computer Systems
    Rosalind Beasley, Digital Transformation Leader, Healthcare & Life Sciences, ROQMetrics, Inc.
  • C
    Build a Data Integrity Program from the Ground Up
    Alice Redmond, Vice President European Operations, CAI
  • 12:00 PM
    Networking Luncheon or Grab & Go Lunch & Learn
  • Understand Pharma 4.0 and the Impact of Digitalization and IoT to CSV
    Chinmoy Roy, Senior Industry Consultant, VALGENESIS
  • 1:15 – 2:45 PM
    Select Between Knowledge Exchange Sessions (4-6)
  • 4
    CSV Project Management – SOPs, Tools and Templates
    Rosalind Beasley, Digital Transformation Leader, Healthcare & Life Sciences, ROQMetrics, Inc.
  • 5
    Audit Data Flows for Part 11 Compliance
    Chris Wubbolt, Principal Consultant, QACV BioPharma Group
  • 6
    Conduct Automation Validation – Strategies for MES, ERP and SAP Software Solutions
    John Hannon, Global Principal for Automation and IT, CAI
  • 2:45 PM
    Afternoon Refreshment Break
  • 3:15 – 4:45 PM
    Select Between Knowledge Exchange Sessions (7-9)
  • 7
    Overcome Challenges in Validating MS Excel Spreadsheets
    Chinmoy Roy, Senior Industry Consultant, VALGENESIS
  • 8
    Implementation of an Effective Audit Trail Review Process
    Matthew LaPierre, Specialist – CSV and Data Integrity Compliance
  • 9
    Human Performance and Data Integrity – Transforming the Culture of Data Integrity
    Danny Hernandez, Associate Director Data Integrity, Bayer
  • 4:45 PM
    Closing Session
  • 7:00 AM
    Coffee and Lite Breakfast
  • 7:30 - 8:15 AM
    Select Between Knowledge Exchange Breakfasts (10-12)
  • 10
    Learn How to Use Testing as a Risk Mitigation Tool
    Kamila Sitkiewicz, Senior Validation Consultant, ecvalidation
  • 11
    Identify Best Practices for Quality Agreements
    Crystal Booth, Regional Manager, PSC Biotech Corporation
  • 12
    Decipher IT Change Control
    Lizzandra Rivera, AD, Quality –Systems, Standards and Compliance, eQuality Systems, Alexion Pharmaceuticals
  • 8:30 – 10:00 AM
    Select Between Knowledge Exchange Sessions (13-15)
  • 13
    Qualification and Data Migration of Hosted GxP Cloud Environments
    Abhinaya, R, Head, Compliance & CSV, Zifo RnD Solutions
  • 14
    Modernize Periodic Review of Computerized Systems
    Lizzandra Rivera, AD, Quality –Systems, Standards and Compliance, eQuality Systems, Alexion Pharmaceuticals
  • 15
    Implement CAPA in Data Integrity Compliance – What to Do When Things Go Wrong
    Matthew LaPierre, Specialist – CSV and Data Integrity Compliance
  • 10:00 AM
    Mid-Morning Refreshment Break
  • 10:30 AM - 12:00 PM
    Select Between Knowledge Exchange Sessions (16-18)
  • 16
    Preparation and Management of FDA Inspections of Computer Systems and Data Integrity
    Chris Wubbolt, Principal Consultant, QACV BioPharma Group
  • 17
    Enable Continuous Delivery of Software in Regulated Environments
    Mike Harnish, President, KSM Technology Partners LLC
  • 18
    Conduct a Risk-Based Data Integrity Remediation
    Loganathan Kumarasamy, Validation Consultant, Zifo RnD Solutions
  • 12:00 PM
    Networking Luncheon or Grab & Go Lunch & Learn
  • App Testing and Software Quality Assurance
    To Be Announced
  • 1:15 - 2:45 PM
    Select Between Knowledge Exchange Sessions (19-21)
  • 19
    Control Risk while Decommissioning Computer Systems
    Michael Brunner, Computer Systems Validation Specialist, Upsher-Smith Laboratories, Inc.
  • 20
    Implement Process Mapping for IT Infrastructures
    Lelia Scott, Executive Director, Global Quality Systems, Charles River
  • 21
    Validating Medical Device Software – A Case Study
    To Be Announced
  • 2:30 PM
    Afternoon Refreshment Break
  • 3:00 - 4:30 PM
    Select Between Knowledge Exchange Sessions (22-23)
  • 22
    Conduct Risk-Based Impact Assessments and Continuous Monitoring
    Steve Thompson, Director Computer Quality Assurance, Science 37
  • 23
    CSV & Data Integrity Master Class – Key Conference Takeaways
    Rashida Ray, President, Array Validation Quality and Compliance (AVQC), Inc.
  • 4:30 PM
    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.
  • Crystal M. Booth, M.M., Regional Manager, PSC Biotech

    Crystal M. Booth, M.M., is a Regional Manager a PSC Biotech and has over 20 years of experience in pharmaceutical microbiology, environmental monitoring, and quality assurance. She obtained her master’s degree in microbiology from North Carolina State University. Crystal is a seasoned award winning technical writer and author of Method Development and Validation for the Pharmaceutical Microbiologist. During her career, Crystal has worked in microbiology, consulting, quality assurance, CDMOs, R&D, and quality control laboratories. Crystal has developed and validated numerous microbial methods and has worked with many different product types.
  • William T. Drummond Jr., Director, Global Computer Validation Quality Assurance, Charles River Laboratories

    William T. Drummond Jr. is currently the Director, Global Computer Validation Quality Assurance, at Charles River Laboratories. His responsibilities include managing and coordinating multi-business unit computer system validation (CSV) projects, quality assurance (QA) oversight of corporate IT, data integrity improvement, training, vendor audits, and internal audits. Besides his current role, he has worked in the biopharma industry since 2000 as a systems integrator and a CSV and QA consultant. He is a retired U.S. Army Lieutenant Colonel whose career included positions with various field artillery units and computer systems development project management offices. He has a Master of Science in Computer Science, concentrating in Artificial Intelligence, from the U.S. Naval Postgraduate School and a Bachelor of Science from the U.S. Military Academy at West Point, NY.
  • Saurav Ghosh, Consulting Director, NNIT Inc.

    Saurav Ghosh is a Consulting Director, leading the Validation, Quality and Process Consulting practice at NNIT Inc. He has more than 14 years of experience playing several leadership, as well as practitioner roles in the areas of Test Automation, IT Service Management, Project/Program Management, Business Process Reengineering and Computer Systems Validation for several Life Sciences organizations.
  • Senthil Gurumoorthi, Associate Director, Gilead Sciences

    Senthil Gurumoorthi leads IT Quality Assurance function at Gilead Sciences, which provides independent oversight for GxP IT Infrastructure & Platforms and manages IT Inspection and audit readiness program. He has over 16 years of diverse experience in biopharmaceutical business ranging from pre-clinical, R&D to manufacturing with leadership expertise on Quality Assurance, Risk Management, Inspection/Audit Management, and Vendor Management. Additionally, as certified Auditor conducted ISO and Part 11/Annex 11 Audits globally. He holds B.E in Electronics & Communication from PSG College of Technology, MS in Electrical Engineering from New Jersey Institute of Technology and Masters in Business Administration (MBA) from Imperial College London.
  • John Hannon, PE, CPIP, CBCP, Global Principal for Automation and IT, CAI

    John Hannon, PE, CPIP, CBCP is an Executive Consultant and Business Principal for Automation and IT at Commissioning Agents. With over 29 years in the pharmaceutical, IT, and process automation fields, he has been instrumental in starting up cutting-edge biotech facilities for companies such as Shire, Elanco, Amgen, Genentech, Pfizer, and Cook. He has managed multi-million dollar projects and project teams across the US and Europe, and is responsible for delivering hundreds of high-profile, mission-critical projects for data center, biotech, pharmaceutical, and medical device customers. Currently he is responsible for the development of automation, MES, and other IT system projects within the international client base. With a demonstrated knowledge of quality assurance and regulatory compliance across the pharmaceutical industry, Mr. Hannon has led national and international seminars with ISPE, contributed to several publications such as Pharmaceutical Technology, and has led speaking venues related to risk-based approaches to smarter integrated system delivery compliant to the FDA, USDA, and EU regulatory agencies. He is an active and sought-after consultant for complex IT and automation problems in the pharmaceutical industry. Mr. Hannon holds a Bachelor of Science in Electrical Engineering from Georgia Tech, has completed studies at Harvard Business School, is a Certified Pharmaceutical Industry Professional and holds Professional Engineering certification in the state of North Carolina. Most recently he has worked with pharmacetical clients to resolve data integrity related regulatory citings.
  • Danny Hernandez, Associate Director Data Integrity, Bayer

    Mr. Hernandez is an experienced leader with over 14 years of Biotech experience. His experience includes: Manufacturing, Operational Excellence, Human Performance and Data Integrity. Through his diverse experience, he is sharing an approach to shape the culture around Data Integrity and Human Performance.
  • Loganathan Kumarasamy, MS, RAC, Zifo RnD Solutions

    Loganathan Kumarasamy (@Loga) is responsible for managing validation and compliance services at Zifo RnD Solutions. He holds a Master’s degree in regulatory affairs from Northeastern University and RAPS RAC (US) certification holder since 2018. With in-depth knowledge of Part 11, EU Annex 11, HIPAA, data integrity principles and applicable GxP regulations for computer systems, medical devices and laboratory systems, he has been providing consultation for top pharmaceutical and product development companies.
  • 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.
  • Kevin Martin, Managing Partner, Azzur Group

    Kevin Martin serves as Managing Partner, Azzur Group, LLC and General Manager, Azzur Group IT. Kevin has more than 40 years of FDA-regulated industry experience that includes management positions at Wyeth and McNeil Pharmaceutical. He is currently a General Manager for Azzur IT and a member of the Azzur Group Board of Directors. He was a member of the PhRMA Computer Systems Validation Sub-Committee (responding to the FDA’s issuance of the 1983 “Blue Book”), was the Core Team Secretary for the PDA Part 11 Task Group (working alongside FDA’s Paul Motise to develop industry guidance) and is a former Chair of the GAMP Americas and GAMP Global Steering Committees, and a contributor to several GAMP Good Practice Guides and Special Interest Groups.
  • Khaled Moussally, Head of Quality Management Systems, Compliance Group

    A Versatile global Quality / IT executive with over 25+ years of quality and compliance, experience in highly regulated life science industries (Medical Device, Bio-tech, Pharmaceutical and Tobacco). Deep understanding in the Manufacturing processes, Equipment validation and Lab Information Systems. Extensive background in Quality Management Systems, regulatory inspections and internal audits. Member of an FDA/Industry CSV Consortium, focusing on developing risk-based recommendation to reduce time and cost in validating software. 19 years at Baxter Healthcare in IT, Quality and Manufacturing, last role was Director of IT Quality Compliance, Created & Owned the Global CSV Process and managed ~ 300 GXP Computerized Systems. Education - BS in Mechanical Engineer
  • Abhinaya Rajasekaran, Compliance & CSV, Zifo RnD Solutions

    Ms. Abhinaya is a Compliance, Validation and Data Integrity Consultant who heads the compliance department at Zifo RnD Solutions. She has consulted pharma, biotech, medical device, diagnostics and product development companies in devising their qualification strategy. Having worked with several global GxP and ERES requirements, ranging from US, UK, EU, Asia pacific, she has expertise in understanding the dynamics, specifics and commonalities in global regulations to provide pragmatic solutions.
  • Alice Redmond, Vice President European Operations, Commissioning Agents Inc.

    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.
  • Lizzandra Rivera, Associate Director, Quality – IT, Alexion Pharmaceuticals

    Mrs. Rivera is a pharmaceutical professional with over 15 years of experience in validation and quality compliance. A Chemical Engineer graduate from the University of Puerto Rico, she has provided strategic leadership and tactical implementation guidance to establish a wide range of computerized systems and equipment, ensuring regulatory compliance is maintained throughout the systems’ lifecycles. She has a well-rounded background encompassing manufacturing, IT and quality assurance.
  • 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.
  • Lelia Scott, Executive Director, Global Quality Systems, Charles River

    Ms. Scott is the Executive Director of the Global Quality Systems team at Charles River Laboratories. She has 15 years of progressively challenging QA experience within the pharmaceutical industry and 7 years in analytical lab sciences. She specializes in data integrity compliance, global process adoption, implementation of enterprise-wide quality systems, computer system validation, laboratory systems, relationship building in cross-functional teams and development of innovative solutions to expedite business processes using electronic systems in compliance with global pharmaceutical regulations. Ms. Scott holds a BSc in Chemistry from the University of Western Ontario and an MBA in Pharmaceutical Management from Fairleigh Dickinson University.
  • Ken Shitamoto, Senior Director, Gilead Sciences

    Ken Shitamoto leads the IT quality engineering function at Gilead Sciences, which performs software quality assurance (testing), validation, and infrastructure qualification. He is a multi-disciplined professional with extensive experience in quality engineering, quality management, project management, and software development. He has been in the biopharmaceutical space since 1993 and has worked both on the manufacturer, vendor, and consulting sides of the business. Additionally, he has also performed over 100 GXP computer systems compliance audits globally. He holds a BA Molecular Cell Biology and MS Computer Science and from UC Berkeley and San Jose State University respectively. He is an avid supporter of the American Lung Association, and Ken and his daughter have raised over 130K dollars to fight lung disease.
  • 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.
  • 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.
  • Chris Wubbolt, Principal, QACV

    Chris 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. Mr. Wubbolt was the previous President of both the New England Region Chapter Society of Quality Assurance (NERCSQA) and the Mid-Atlantic Region Society of Quality Assurance (MARSQA), and is currently the chairperson of the MARSQA computer validation committee.

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

  • A nationwide network of experts delivering professional services across the life sciences industry, Azzur Group is dedicated to providing clients with efficient, innovative quality and compliance solutions from Discovery to Delivery™. With more than 250 industry partners, including 80% of the top pharma/biotech manufacturers in the U.S., Azzur Group provides carefully calibrated and efficiently executed project management, process engineering, and compliance services. As one of the fastest growing private companies in America, Azzur Group provides clients with the consulting, facility solutions, engineering, validation, IT, technical, training, and laboratory services and solutions they need to remain innovative and competitive.
    Website: https://www.azzur.com/
  • KSM Technology Partners’ mission is to deliver maximum returns on your technology investment and human capital. We have decades of experience helping our customers in the life sciences industries build rock-solid validation-ready solutions, using proven agile software development techniques. Our managed testing service is specifically tailored to the unique needs of customers in the GxP space. It uses functional test automation to complete IQ/CQ/OQ/PQ tests in a fraction of the time, without incurring the steep costs of building and maintaining an in-house automation competency. As the pace of SaaS software releases accelerates, we help our customers keep their configured systems in a validated state, without enlisting an army of manual testers or expensive programmers.
    Website: https://www.ksmpartners.com/
  • NNIT has a long and proven experience within Compliance, Test and Validation consultancy in the life sciences industry. Due to NNIT’s roots in life sciences and regulatory domain expertise, we ensure that our clients comply with regulatory requirements in an efficient and cost conscious manner.
    Website: https://www.nnit.com/
  • PSC Biotech Corporation has three unique, active divisions within the parent company: our professional service division, PSC Biotech™; our software division, PSC Software™, and our contract manufacturing facility, BioTechnique. Each division is heavily rooted in regulatory expertise in order to meet the ever-changing needs of our clients around the globe.
    Website: https://www.biotech.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/
  • CIMINFO Software Inc. (CSI) provides a wide range of software solutions and compliance services that reduce costs and improve operational efficiency while complying with 21 CFR Part 11 and GxPs. CSI anticipates, defines, evaluates and solves the technical and regulatory issues that arise in a constantly changing environment to help clients achieve their business goals. The firm leverages 25 years of innovation, experience and knowledge in designing, developing and implementing technology solutions from the plant floor to the top floor.
    Website: https://part11solutions.com/contact-us/
  • Since 2010, the FDAzilla platform has been utilized by hundreds of clients, ranging from Fortune 500 companies in every FDA-regulated industry, to law firms, to insurance companies and banks, and to consultants. Our data and analytics have been cited by major media outlets such as MSNBC, WSJ, and the Boston Globe, and FDAzilla.com is viewed more than 1 million times per year.

    Website: https://fdazilla.com/
  • Novatek International’s mission is to produce regulatory compliant software solutions to the pharmaceutical, biotech and other health-care industries. Our goal is to improve patient safety by producing solutions that reduce the risks associated with pharmaceutical manufacturing and contribute to product quality.

    Website: https://ntint.com/
  • QACV offers comprehensive quality assurance, compliance, and computer validation consulting services to meet your regulatory needs. We provide professional consulting services to FDA regulated life science industries and use proven methodologies to achieve sustainable compliance for your organization.
    Website: http://www.qacvconsulting.com/
  • Global Leader in Paperless Validation
    Website: http://www.valgenesis.com/
  • Inspiring Operational Excellence through Best-in-Class CQV Processes
    Website: http://validation.org/



  • PharmaVOICE magazine reaches more than 46,000 BPA qualified subscribers and 60,000 users with its digital edition. PharmaVOICE is the forum that allows business leaders to engage in a candid dialogue on the challenges and trends impacting the industry. PharmaVOICE provides readers with insightful and thought-provoking commentary in a multiple-perspective format through forums, topics, and articles covering a range of issues from molecule through market. PharmaVOICE subscribers are also kept abreast of the latest trends and information through additional media resources, including Social Media, WebLinx Interactive WebSeminars, Podcasts, Videocasts, White Papers, E-Surveys and e-Alerts.
    Website: https://www.pharmavoice.com

Partners

    More Information To Follow Soon

Venue

Details

Start:
December 9
End:
December 11
Event Category:

Venue

Wyndham Philadelphia Historic District
400 Arch Street
Philadelphia, PA 19106 United States
+ Google Map
Phone:
(215) 923-8660
Website:
http://www.phillydowntownhotel.com/

Pricing & Registration

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