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CSV & DATA INTEGRITY COMPLIANCE CONGRESS

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

December 3 - December 5

Washington, D.C., United States

CSV & Data Integrity Compliance Congress Returns to Washington, D.C.!

 

The FDA has issued many Warning Letters emphasizing CSV & DI 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 & Data Integrity Compliance Congress is headed back to Washington D.C. to showcase the latest regulations, protocols, methodology and actions that you can immediately implement.

 

40 TUTORIALS – UNPARALLELED COVERAGE ON BEST-IN-CLASS INNOVATIVE PROCEDURES AND TECHNOLOGY

 

DATA INTEGRITY GOVERNANCE AND VALIDATION

  • Stay Up-to-Speed with Regulatory Thinking
  • Implement a Practical, Risk-Based Approach to Audit Trail Review
  • Identify and Investigate Root Causes of Lapses and Identify Gaps
  • Construct of a Program from the Ground Up
  • Strategies to Ensure Compliance Between Sites
  • Use a Maturity Model for Internal Audits
  • Map your Data Lifecycle Using Process Maps

 

COMPUTER SYSTEMS AND SOFTWARE VALIDATION

  • Use Critical Thinking and Implement a Risk-Based Approach
  • Develop an IT Infrastructure and Network Qualification Roadmap
  • Address Malicious Threats in Our Modern Landscape
  • Implement an Automated Audit Trail for Validated MS Excel® Spreadsheets
  • Implement Change when Lacking Resources and Management Support
  • Qualify the Cloud – A Compliant Approach for SAAS, IAAS and Other Software Services
  • Conduct Risk-Based Impact Assessments and Continuous Monitoring
  • Learn How to Respond to FDA Inspectional Findings

 

And So Much More…Download the Brochure for Full Details! 

 

Personnel in the Following Environments Should Attend:

  • Validation
  • QA/QC
  • Engineering
  • IT
  • Quality Control
  • Manufacturing Management
  • Laboratory Management
  • Regulatory Affairs

 

This event is also appropriate to business development and sales managers that offer innovative solutions for quality departments, validation departments, data collection and statistics.

Agenda

  • 12:00 PM
    Conference Registration
    Coffee & Lite Snacks On-the-Go
  • 1:00 PM
    Chairperson’s Opening Remarks
  • 1:30 PM
    Knowledge Management – Compliance by Understanding Warning Letter Trends
    Erik Muegge, M.S., Manager Operations Quality, Abbott Laboratories – Diagnostics Division
  • 2:00 PM
    Compliance Intelligence – Staying Up-to-Speed with Regulatory Thinking
    Camilla Perrotta-Fowler, cGMP Compliance Training Senior Specialist, Bayer
  • 2:30 PM
    Regulatory Town Hall – Navigating FDA and Global Regulations and Inspections
  • ~
    Erik Muegge, M.S., Manager Operations Quality, Abbott Laboratories – Diagnostics Division
  • ~
    J Loren Smith, Senior Manager, Global Compliance & Ethics, Computer Systems/Data Integrity, BioMarin Pharmaceutical
  • ~
    Lizzandra Rivera, Associate Director, Quality – IT, Alexion Pharmaceuticals
  • ~
    Camilla Perrotta-Fowler, cGMP Compliance Training SeniorSpecialist, Bayer Pharmaceuticals
  • 3:00 PM
    Networking Refreshment Break
  • 3:30 PM
    Homo Sapiens atque Integritas Notitia – (Human Beings and Data Integrity)
    J Loren Smith, Senior Manager, Global Compliance & Ethics, Computer Systems/Data Integrity, BioMarin Pharmaceutical
  • 4:00 PM
    Adapt to the Changing Validation Landscape in a Cloud Environment
    Saurav Ghosh, Consulting Director, NNIT
  • 4:30 PM
    Implement Practical, Risk-Based Approach to Audit Trail Review
    Calvin Kim, GxP IT Auditor, Bayer
  • 5:00 PM
    Temple University Scholarship Award & Welcome Reception
  • Close of Day One
  • 7:00 AM
    Coffee and Lite Breakfast
  • 7:30 AM
    Select Between Knowledge Exchange Sessions (1-3)
  • (1)
    Communicating CSV and Quality Compliance Worldwide
    Byron Mattingly, Ph.D., Software Division Chair, American Society for Quality
  • (2)
    How Much Validation is Enough?
    Sandra Acosta, President & CEO, Orion Scientifc Group
  • (3)
    Identify and Investigate Root Causes of Data Integrity Lapses
    Chris Wubbolt, Principal Consultant, QACV Consulting, LLC
  • 8:30
    Select Between Knowledge Exchange Sessions (4-6)
  • (4)
    Use Critical Thinking and Implement Risk-Based Approach to Computerized System Validation
    Calvin Kim, GxP IT Auditor, Bayer
  • (5)
    Develop an IT Infrastructure and Network Qualification Roadmap
    Chinmoy Roy, Data Integrity and CSV SME, Consultant
  • (6)
    Construction of a Data Integrity Program from the Ground Up
    Matthew LaPierre, Senior QA Specialist, Data Integrity, Ipsen Bioscience, Inc.
  • 10:00
    Mid-Morning Refreshment Break
  • 10:30
    Select Between Knowledge Exchange Sessions (7-9)
  • (7)
    Use Lean Principles to Improve Quality in Your Validation Processes
    Lizzandra Rivera, Associate Director Quality - IT, Alexion Pharmaceuticals Inc
  • (8)
    Risk-Based CSV Decision Making Across Multiple Sites
    Byron Mattingly, Ph.D., Software Division Chair, American Society for Quality
  • (9)
    FDA’s “Live Review” Inspection Technique – Are your System Owners and SMEs Ready?
    Camilla Perrotta-Fowler, cGMP Compliance Training Sr. Specialist, Bayer
  • 12:00
    Lunch & Learns (10-13)
  • (10)
    Keeping up with CSV Tools and Innovative Approaches
    Steve Thompson, Senior Manager, Professional Services, ValGenesis
  • (11)
    Create a Data Integrity Risk Matrix Using MHRA Guidance
    Mehron Mirian, Senior Quality Manager, Molecular Templates
  • (12)
    Identifying GAPS in Data Integrity Compliance
    Sandra Acosta, President & CEO, Orion Scientic Group
  • (13)
    Computer Systems Validation Senior-Level Master Class
    Kristin Shuler, Sr. Validation Engineer at Cedarburg Pharmaceuticals
  • 1:15 PM
    Select Between Knowledge Exchange Sessions (14-16)
  • (14)
    CSV & DI Compliance and Inspection Readiness
    Robert J. Wherry, MSc, MS, CQA, CPGP, CPIP, Head – R&D Data Systems QA & Compliance, Shire
  • (15)
    CyberSecurity – Addressing Malicious Threats
    Bryan Blank, Principal & Chief Information Offcer, Sharp Point Security Solutions, LLC | Kevin Martin, General Manager and Managing Partner, Azzur Group, LLC
  • (16)
    Managing Changes in Computer Systems
    Omar Craviotto, Senior Validation Engineer, Sutro BioPharma
  • 2:45 PM
    Afternoon Refreshment Break
  • 3:15 PM
    Select Between Knowledge Exchange Sessions (17-19)
  • (17)
    Implement Validation Protocols for Excel™ Spreadsheets
    Jeffrey Little, Section Manager, Abbott Laboratories – Diagnostics Division
  • (18)
    Develop and Document Quality Test Scripts
    Erik Muegge, M.S., Manager Operations Quality, Abbott Laboratories
  • (19)
    Build a Global Data Integrity Program – Strategies to Ensure Compliance Between Sites
    Lelia Scott, MBA, BSc., Senior Director, Global Quality Systems, Charles River
  • 4:45-5:15
    Automated Data Integrity Compliance and Monitoring
    Sanjay Agrawal, President and CEO, CIMINFO Software
  • 5:15
    Close of Day 2
  • 7:00 AM
    Coffee and Lite Breakfast
  • 7:30 - 8:15 AM
    Select Between Knowledge Exchange Breakfasts (20-22)
  • (20)
    How to Implement Change when Lacking Resources and Management Support
    Omar Craviotto, Senior Validation Engineer, Sutro BioPharma
  • (21)
    Adding Technical Controls to Excel™ Spreadsheets to Meet Electronic Record and Predicate Rules
    Heather Longden, Senior Marketing Manager, Informatics and Regulatory Compliance, Waters Corporation
  • (22)
    DI Compliance for Paper Based Systems - The PICs approach
    Chinmoy Roy, Data Integrity and CSV SME, Consultant
  • 8:30 AM
    Select Between Knowledge Exchange Sessions (23-25)
  • (23)
    Cloud Qualification – A Compliant Approach for Software
    Chris Wubbolt, Principal Consultant, QACV Consulting, LLC
  • (24)
    Conduct Risk-based Revalidations and Periodic Reviews
    William Honeck, Vice President, West Coast Operations, VTI Life Sciences, Inc.
  • (25)
    Use a Data Integrity Maturity Model for Internal Audits – Map your Data Life Cycle Using Process Maps
    Jay Waterbury, Associate Director – Computer Systems / Data Integrity, Global Compliance & Ethics, BioMarin Pharmaceutical Inc.
  • 10:00 AM
    Mid-Morning Refreshment Break
  • 10:30 AM
    Select Between Knowledge Exchange Sessions (26-28)
  • (26)
    How to Conduct Risk-Based Impact Assessments
    Steve Thompson, Senior Manager, Professional Services, ValGenesis
  • (27)
    Perform a Laboratory Data Integrity Audit
    Heather Longden, Senior Marketing Manager, Informatics and Regulatory Compliance, Waters Corporation
  • (28)
    Conduct a Data Integrity Risk Assessment Using Data Provenance
    Chinmoy Roy, Data Integrity and CSV SME, Consultant
  • 12:00
    Lunch and Learns (29-32))
  • (29)
    Data Integrity Senior-Level Master Class
    Mehron Mirian, Senior Quality Manager, Molecular Templates
  • (30)
    Train the Trainer – How to Educate Personnel in Execution
    Kristin Shuler, Senior Validation Engineer at Cedarburg Pharmaceuticals
  • (31)
    Manage Suppliers on CSV Compliance
    Robert J. Wherry, Head – R&D Data Systems QA & Compliance, Shire plc
  • (32)
    Strategies to Move from Paper to Electronic Systems
    Lelia Scott, MBA, BSc., Senior Director, Global Quality Systems, Charles River
  • 1:15 PM
    Select Between Knowledge Exchange Sessions (33-35)
  • (33)
    Conduct a Part 11 Gap Assessment
    Rashida Ray, President, Array Validation Quality and Compliance (AVQC), Inc.
  • (34)
    Responding to Data Integrity Inspectional Findings
    Robert J. Wherry, Head – R&D Data Systems QA & Compliance, Shire plc
  • (35)
    How to Change Your Culture in Handling Data Integrity
    J Loren Smith, Senior Manager, Global Compliance & Ethics, Computer Systems/Data Integrity, BioMarin Pharmaceutical, Inc.
  • 2:45 PM
    Afternoon Refreshment Break
  • 3:00 PM
    Select Between Knowledge Exchange Sessions (36-37)
  • (36)
    Decommissioning – The End of a Computer System Life Cycle
    Carlos Pereira, Senior Computer Validation Specialist, VTI Life Sciences
  • (37)
    Lab Instrument Qualification and Data Integrity
    Rashida Ray, President, Array Validation Quality and Compliance (AVQC), Inc.
  • 4:30 PM
    Close of Conference

Faculty

  • Sandra Acosta, President & CEO, Orion Scientifc Group

    Orion Group, Life Science Consulting service dedicated to provide expertise, knowledge and solutions toward innovating modern pharma/biotech organizations. Orion work collaboratively with each unique client to understand their needs identifying value-added solutions that are results oriented, quality centered and cost effective. We support each client to implement agreed-upon solutions in a sustainable manner, while ensuring knowledge transfer, thereby supporting leadership development and empowerment. Our mission is to support the development and manufacture of safe and effective medicine for all living kind toward different applications.
  • Sanjay Agrawal, President and CEO, CIMINFO Software

    Sanjay Agrawal is President and CEO of CIMINFO Software. He has over 25 years of experience in Computer Systems Validation, and Data Integrity Compliance. Early in his career, Sanjay pioneered risk-based validation methodologies for large scale enterprise systems such as ERP by developing a data framework, and identifying the controls necessary for each data category. He has developed facility-wide Master Validation Plans that included systems, people, and processes and managed validation projects for systems at every level ranging from spreadsheets/databases, PLCs and equipment to LIMS, HPLC, SCADA, MES and ERP. Sanjay is also a pioneer in introducing Part 11 compliance technologies for spreadsheets and Access databases to the industry that are in use today at hundreds of FDA-regulated firms worldwide.
  • Brian Blank, Principal & Chief Information Officer, Sharp Point Security Solutions, LLC

    Bryan Blank serves as Principal/Chief Information Officer for Sharp Point Security Solutions, in Reston Virginia. With more than 20 years’ experience in information technology, risk management, compliance, systems engineering, and security assessments, Bryan works hand in hand with clients to evaluate processes and implement enterprise security architectures. Prior to his tenure with Sharp Point, Bryan was Chief Information Security Officers at SEV1Tech and PPC.
  • Omar Craviotto, Senior Validation Engineer, Sutro BioPharma

    Mr. Craviotto is an experienced Biotechnology professional with over fifteen 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. He is also an expert in downstream purification techniques including; column chromatography, Tangential Flow Filtration (TFF), viral filtration, bulk filtration/freeze.
  • 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.
  • William Honeck, Vice President, West Coast Operations, VTI Life Sciences, Inc.

  • Calvin Kim, GxP IT Auditor, Bayer

    Calvin is a seasoned quality professional with over 25 years of experience in various sectors of GXP regulated industries. As a core member of Bayer QA organization responsible for quality oversight and regulatory compliance assessment of computerized systems (CS) and technology used in pharmaceutical, consumer health, animal health, and medical device sectors across a global company, he has completed more than 200 audits of IT suppliers and CS projects. Considered as a thought leader in CS validation practices, and electronic records and electronic signature related regulations within the organization, he is passionate about engaging in CS implementation and data integrity compliance discussions with the industry colleagues around the world. He is actively engaged in various industry forums, including his current role as Chair for DIA’s Information Quality, Compliance, and Technology (DIA IQCT) Community and Co-chair for Mid-Atlantic Regional Society of Quality Assurance (MARSQA) Computer Validation Committee (CVC).
  • Matthew LaPierre, Senior QA Specialist, Data Integrity, Ipsen Bioscience, Inc.

    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.
  • Jeffrey Little, Section Manager, Abbott Laboratories – Diagnostics Division

    Jeff has 20+ years of experience in multiple facets of CSV including: 21 CFR Part 11, Data Integrity, software systems, and equipment and processes. He has experience managing and supporting validation projects of varying complexity, from test equipment to enterprise class systems, within the medical device industry. He has supported CSV initiatives globally for Abbott Labs, including consultations with suppliers. Jeff has a BS degree in Operations Management and an MS degree in Computer Education and Cognitive Systems, as well as, a Microsoft Solution Developer certificate. He also holds ASQ Certifications as a CQA, a CMQ/OE, and as a CSQE.
  • Heather Longden, Senior Marketing Manager, Informatics and Regulatory Compliance, Waters Corporation

  • Kevin Martin, Managing Partner, Azzur

    Kevin Martin serves as Managing Partner, Azzur Group, LLC and General Manager, Azzur Group IT. Kevin has over 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, helping Life Science customers with their technology and compliance solutions, and is a member of the Board of Directors for Azzur Group LLC. He is considered a subject matter expert on risk-based systems selection, implementation and validation conducted within QA, IT, Manufacturing, Operations, Clinical and R&D in FDA regulated environments. 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. He received his Bachelor of Science degree in Chemistry from Delaware Valley University (formerly Delaware Valley College of Science and Agriculture) and his Master of Engineering from Penn State University.
  • Byron Mattingly, Ph.D., Software Division Chair, American Society for Quality

    Dr. Byron Mattingly is currently the Chair of the Software Division of the American Society for Quality. He is a senior level systems and software quality engineering manager with over 17 years' experience in pharma, healthcare IT and medical devices. Dr. Mattingly graduated with a bachelor's from Princeton University, a PhD and Master's from Stony Brook, an MPhil from University of St Andrews (Scotland), and an MBA and a Master's in Public Health from the University of Massachusetts at Amherst.
  • Mehron Mirian, Senior Quality Manager, Molecular Template

    Mehron Mirian has more than 18 years of experience in Quality and Engineering in the Medical Device, Pharmaceuticals, Biotechnology and Diagnostics industries. Mehron, who holds a BS in Biology, has worked for companies such as Cardinal Health, Bio-Rad, B.Braun, Avid, and Molecular Templates. Mehorn currently manages quality department in Molecular Templates as the Senior Quality Manager.
  • Erik Muegge, M.S., Manager Operations Quality, Abbott Laboratories – Diagnostics Division

    Erik Muegge’s experience is focused on FDA and related regulated environments for pharmaceuticals, consumer products, and medical devices. His specific areas of work include Quality Systems, operations, outsourcing, process re-engineering, project management, product development life cycle (R&D through Launch) and validation. Erik has; led efforts in several PPC (Production and Process Controls) areas; harmonized validation activities globally across seven sites; audited quality systems of strategic partners; been recognized as a global SME resulting in three industry awards.
  • Carlos Pereira, Senior Computer Validation Specialist, VTI Life Sciences

  • Camilla Perrotta-Fowler, cGMP Compliance Training Senior Specialist, Bayer Pharmaceuticals

    Camilla is an experienced quality professional with 15 years of GMP regulated environment experience within the biotech industry, including: Product Release, Training, Complaints/Deviation Investigation, Quality Audit (Internal and External), Quality Risk Management/Facilitation, and Data Integrity. By leveraging regulatory requirements and industry expectations, Camilla’s current focus is on creating and delivering training content covering cGMP Compliance, Data Integrity, Regulatory Intelligence, and Human Performance.
  • 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.
  • Lizzandra Rivera, Associate Director, Quality - IT, Alexion Pharmaceuticals, Inc.

  • 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.
  • Lelia Scott, MBA, BSc., Senior Director, Global Quality Systems, Charles River

    Ms. Scott is a senior management quality professional with 14 years of progressively challenging QA experience within the pharmaceutical industry, and 7 years’ in analytical lab sciences. Her specializations include: global process adoption, implementation of enterprise-wide quality systems, global 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. She holds a Bachelor in Chemistry from the University of Western Ontario and an MBA in Pharmaceutical Management from Fairleigh Dickinson University
  • Kristin Shuler, Sr. Validation Engineer at Cedarburg Pharmaceuticals

  • J Loren Smith, Senior Manager, Global Compliance & Ethics, Computer Systems/Data Integrity, BioMarin Pharmaceutical

    Loren has over 28 years of experience specializing in computer systems compliance (from the IT, QA, and Compliance perspectives) in medical device, biotech, pharmaceutical, analytical instrumentation, and software companies. Loren has also been an instructor at University of California, Berkeley, since 2006, teaching computer systems compliance to students in clinical research.
  • Steve Thompson, Senior Manager, Professional Services, ValGenesis

    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.
  • Jay Waterbury, Associate Director – Computer Systems / Data Integrity, Global Compliance & Ethics, BioMarin Pharmaceutical Inc.

    Jay Waterbury joined BioMarin in 2015 as the initial member of its Global Compliance & Ethics group to establish a center of excellence focusing on computer systems and data integrity. Jay has 20+ years of experience specializing in computer systems compliance in a variety biotech and pharmaceutical companies ranging from mid-sized to global.
  • Robert J. Wherry, MSc, MS, CQA, CPGP, CPIP, Head – R&D Data Systems QA & Compliance, Shire

    Mr. Wherry has thirty-five (35) 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, and teaches part-time as an Adjunct Professor within the STEM Division's Biotechnology Program at Middlesex Community College in Massachusetts. Mr. Wherry has a Bachelor’s degree in Chemical Engineering from Lehigh University. He has a Master of Science, with distinction, from the University of Strathclyde (Glascow, UK) in Pharmaceutical Quality & GMP. He also has a Master of Science in Regulatory Affairs from Northeastern University. Bob also has certifications from ASQ and ISPE.
  • Chris Wubbolt, Principal Consultant, QACV Consulting, LLC

    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

  • PLATINUM


  • 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/
  • SILVER


  • 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/
  • FDAzilla, a subsidiary of Govzilla, is at the forefront of leveraging the power of Big Data and AI to make government data accessible, usable and valuable to everyone who needs it. Top Pharma Companies, Food Manufacturers, Medical Device Companies, and Service firms from around the globe rely on Govzilla to mine and process government inspection, enforcement, and registration data in order to quantify risk signals about their suppliers, identify market opportunities, benchmark against their peers, and to prepare for the latest inspection trends. Our data and analytics have been cited by major media outlets such as MSNBC, WSJ, and the Boston Globe. Our website, FDAzilla.com is viewed more than 1 million times per year. We are passionate about our mission to solve novel data and analytics problems for our customers. At Govzilla, we’re committed to our work, to our customers, and to having fun.
    Website: https://fdazilla.com/
  • Global leader of measurement and precision instruments for industry, laboratories and retail
    Website: http://www.mt.com
  • Global Leader in Paperless Validation
    Website: http://www.valgenesis.com/
  • Inspiring Operational Excellence through Best-in-Class CQV Processes
    Website: http://validation.org/
  • Trusted by hundreds of FDA-regulated firms in over 30 countries, CIMINFO provides Data Integrity and 21 CFR Part 11 compliance solutions that reduce compliance costs and improve efficiency. Existing spreadsheets and Access databases can be made Part 11 compliant with minimal effort. Enterprise products automate business processes such as data integrity management/auditing, document management, engineering data/drawing controls, and training.
    Website: https://part11solutions.com/

Partners

  • Temple University School Of Pharmacy

    RAQA: Combined, Defined, and Online. The Leader in Education RA and QA Professionals for 50 Years
    Website: http://www.temple.edu/pharmacy_qara
  • American Pharmaceutical Review

    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:
December 3
End:
December 5
Event Category:

Venue

The Dupont Circle Hotel
1500 New Hampshire Avenue NW
Washington, D.C., DC 20036 United States
+ Google Map
Phone:
+1 202 483 6000
Website:
www.doylecollection.com/dupontcircle.com

Pricing & Registration

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