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DATA INTEGRITY INSPECTION READINESS SUMMIT

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Risk-Based Approaches that Impress FDA Investigators

March 25 - March 27

Philadelphia, United States



FDA Warning Letters Highlight Data Integrity Deficiencies

 

Data Integrity remains the life science industry’s greatest challenge as Warning Letters continue to rise year-over-year. 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 Data Integrity Inspection Readiness Summit is headed to Philadelphia to showcase the protocols, methodology and actions necessary to avoid regulatory action.

 

Be Prepared for the FDA Inspection Headed to Your Facility Soon!

  • Understand the Human Factor for Compliance
  • Learn How to Build a Program from the Ground Up
  • Identify the Root Cause of Inaccuracies
  • Conduct an Audit/Gap Assessment and Implement Corrective Action
  • Comply Across the GxP Environment
  • Benchmark With Manufacturing, Laboratory and Clinical Top Companies
  • Address Malicious Threats through Cybersecurity Best Practices
  • Conduct Data Integrity Risk Assessments
  • Know How to Handle Audit Trails

 

Personnel in the Following Environments Should Attend:

  • Validation
  • QA/QC
  • Data Integrity and Document Management
  • Regulatory Affairs
  • Manufacturing, Laboratory and Clinical Management

 

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

 

This Conference is Co-Located with VALIDATION UNIVERSITY with In-Depth Coverage On:

  • Process Validation and Continued Process Verification
  • Cleaning Validation & Critical Cleaning Processes
  • Facility and Equipment Qualification
  • Critical Utility Qualification – HVAC, Water and Gas
  • Computer Systems Validation

 

Click Here to View the Agenda-At-A-Glance

Agenda

  • 12:00
    Conference Registration
    Coffee & Lite Snacks On-the-Go
  • 1:00
    Chairperson’s Opening Remarks
  • 1:15
    Breaking News - FDA Releases Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry
    Chris Wubbolt, Principal, QACV Consulting, LLC
  • 2:00
    Tips on Handling Data Integrity and Validation Inspections – An FDA Perspective
    Karyn M. Campbell, Director, Investigations Branch II, Division of Pharmaceutical Quality Operations, U.S. Food and Drug Administration (FDA)
  • 2:30
    Staying Ahead of the Validation and GMP Regulatory Curve through Warning Letter Knowledge
    Erik Muegge, M.S., Manager Operations Quality, Abbott Laboratories
  • 3:00
    Afternoon Networking Refreshment Break
  • 3:30
    Overcome the Top Five Validation Challenges
    Connie Hetzler, Global Head of Validation, Alcon Laboratories
  • 4:00
    Implementation of a Risk-based Cleaning Validation Management System
    Parsa Famili, President & CEO, Novatek International
  • 4:30
    A Systematic Approach for a Knowledge Management Model
    Robert J. Wherry, Head – R&D Data Systems QA & Compliance, Takeda
  • 5:00
    Temple University Scholarship Award & Welcome Reception
  • Close of Day One
  • 7:00
    Coffee and Lite Breakfast
  • 7:30-8:15
    Select Between Knowledge Exchange Sessions (1-4)
  • (1)
    Documentation Requirements for Successful Validation
    Gamal Amer, Ph.D. Principal, Premier Compliance Services
  • (2)
    Qualification of Water Systems, Clean Steam Systems & Process Gasses
    Patrick Mullin, Senior CQV/QAV Consultant, DPS Group Global
  • (3)
    Strategies to Move to Electronic Systems
  • (4) DATA INTEGRITY INSPECTION READINESS SUMMIT
    Data Integrity – Navigating the Maze of Regulations
    Kevin Martin, Managing Partner, Azzur Group
  • 8:30-10:00
    Select Between Knowledge Exchange Sessions (5-8)
  • (5)
    Successful Implementation of a 3-Stage Process Validation Program
    Mehron Mirian, Senior Quality Manager, Molecular Templates
  • (6)
    Risk-Based Cleaning Validation – Key Elements to a Successful Program
    Sunil Patel, Senior Global Technical Leader, Ecolab Life Sciences
  • (7)
    Implementation of a Risk-based Verification Strategy for CQV
    Joscelyn Bowersock, Regulatory and Quality Manager, Carolina BioOncology Institute
  • (8) DATA INTEGRITY INSPECTION READINESS SUMMIT
    Construction of a Data Integrity Program from the Ground Up
    Matthew LaPierre, Data Integrity Program Manager, Ipsen Bioscience
  • 10:00
    Mid-Morning Refreshment Break
  • 10:30-12:00
    Select Between Knowledge Exchange Sessions (9-12)
  • (9)
    Introduction to Validation Statistics for Non-Statisticians
    Raul Soto, Senior Principal Software Engineer, Johnson & Johnson Vision Care
  • (10)
    Key Considerations for Process Validation and Successful Tech Transfer
    Philip Jarvis, Validation Site Lead, Alcon
  • (11)
    Implement a Risk-Based Computer Systems Validation Program
    Lizzandra Rivera, Associate Director, Enterprise – e-Systems, Alexion Pharmaceuticals
  • (12) DATA INTEGRITY INSPECTION READINESS SUMMIT
    Human Performance and Data Integrity - Transforming the Culture
    Danny Hernandez, Associate Director Data Integrity, Bayer
  • 12:00
    Lunch & Learns, Select Between (13-16)
  • (13)
    Training Personnel in Validation Execution
    Chris Wubbolt, Principal Consultant, QACV Consulting, LLC
  • (14)
    Go Beyond Warning Letter Trends and Guidance Documents
    Michael de la Torre, CEO, FDAZilla
  • (15)
    Conduct Risk-Based Revalidations and Periodic Reviews of Systems
    Jorge A. Cordero, Principal Validation Engineer, Bausch + Lomb
  • (16) DATA INTEGRITY INSPECTION READINESS SUMMIT
    CyberSecurity – Protecting Data Against Malicious Threats
    To Be Announced
  • 1:15–2:45
    Select Between Knowledge Exchange Sessions (17-20)
  • (17)
    Risk-based IQ/OQ/PQ Development and Execution
    Jorge A. Cordero, BSChE, MBA-GM, Principal Validation Engineer, Bausch + Lomb
  • (18)
    Medical Device Process Validation Implementation Case Study
    David W. Vincent, Ph.D., CEO, VTI Life Sciences
  • (19)
    Hiring the People Who Make Validation Great
    Patrick Mullin, Senior CQV/QAV Consultant, DPS Group Global
  • (20) DATA INTEGRITY INSPECTION READINESS SUMMIT
    Data Integrity Assessments – Moving Past Assessment to Implementation
    Lizzandra Rivera, Associate Director, Quality – IT, Alexion Pharmaceuticals
  • 2:45
    Afternoon Refreshment Break
  • 3:15– 4:45
    Select Between Knowledge Exchange Sessions (21-24)
  • (21)
    Apply Quality Risk Management (QRM) in Validation Processes
    Connie Hetzler, Global Head – Validation, Alcon Laboratories
  • (22)
    The Validation Master Plan (VMP) – Plans that Impress FDA Investigators
    David W. Vincent, Ph.D., CEO, VTI Life Sciences
  • (23)
    Performance Qualification Versus Process Validation
    Erik Muegge, M.S., Manager Operations Quality, Abbott Laboratories – Diagnostic Division
  • (24) DATA INTEGRITY INSPECTION READINESS SUMMIT
    Data Integrity – Remediation Projects and Building for the Future
    Alice Redmond, Vice President European Operations, Commissioning Agents Inc.
  • 4:45 Day Two Closing Session
    Considerations for Using Spreadsheets in a GxP Compliant Environment
    Sanjay Agrawal, President and CEO, CIMINFO Software
  • Close Of Day Two
  • 7:00
    Coffee and Lite Breakfast
  • 7:30–8:15
    Select Between Knowledge Exchange Sessions (1-4)
  • (25)
    CQV Master Class – Benchmark with Your Peers
    Alice Redmond, Vice President European Operations, Commissioning Agents Inc.
  • (26)
    Managing Changes in Validation Processes
    Mehron Mirian, Senior Quality Manager, Molecular Templates
  • (27)
    Prepare for Validation Inspections and Respond to Findings
    Milan Kalinic, Validation Lead, Alexion Pharmaceuticals
  • (28) DATA INTEGRITY INSPECTION READINESS SUMMIT
    Data Integrity Risk Assessments – Using Process Flow Charts
    Chinmoy Roy, Industry Consultant, ValGenesis Inc
  • 8:30–10:00
    Select Between Knowledge Exchange Sessions (5-8)
  • (29)
    Continued Process Verification (CPV) – Maintain the Validation State
    Philip Jarvis, Site Validation Lead, Alcon
  • (30)
    Network Infrastructure and Cloud Qualification
    Lelia Scott, Senior Director Global Quality Systems, Charles River Laboratories
  • (31)
    Machine Learning – Validation and Data Integrity Compliance
    Steve Thompson, Director Computer Quality Assurance, Science 37
  • (32) DATA INTEGRITY INSPECTION READINESS SUMMIT
    Managing FDA DI Inspections and Responding to Inspectional Findings
    Eileen Cortes, Associate Director for QA and Validation, BioMarin
  • 10:00
    Mid-Morning Refreshment Break
  • 10:30 – 12:00
    Select Between Knowledge Exchange Sessions (33-36)
  • (33)
    Apply Quality Risk Management (QRM) in Equipment Qualification
    Patrick Mullin, Senior CQV/QAV Consultant, DPS Group Global
  • (34)
    Developing and Documenting Quality Test Scripts
    Erik Muegge, M.S., Manager Operations Quality, Abbott Laboratories
  • (35)
    Conduct a Part 11 Gap Assessment
    Chris Wubbolt, Principal Consultant, QACV Consulting, LLC
  • (36) DATA INTEGRITY INSPECTION READINESS SUMMIT
    Real World Case Studies in Data Integrity Audits
    Chinmoy Roy, Industry Consultant, ValGenesis Inc
  • 12:00
    Lunch & Learns, Select Between (37-40)
  • (37)
    Quality by Design in Process Validation
    Joscelyn Bowersock, and Quality and Regulatory Manager, Carolina BioOncology Institute
  • (38)
    Importance of the Quality Agreement in Managing Vendors
    Bette Monnot-Chase, Director, CMC & Quality, Asklepion Pharmaceuticals
  • (39)
    Establish Cleaning Residue Limits and Acceptance Criteria
    To Be Announced
  • (40)
    Automated Risk-Based Data Integrity Processes
    Steve Thompson, Director Computer Quality Assurance, Science 37
  • 1:15- 2:30
    Select Between Knowledge Exchange Sessions (41-43)
  • (41)
    Statistical Process Controls – Construct and Analyze Control Charts
    Raul Soto, Senior Principal Software Engineer, Johnson & Johnson Vision Care
  • (42)
    Qualification Strategies for Temperature Mapping & Storage Chambers
    Bette Monnot-Chase, Director, CMC & Quality, Asklepion Pharmaceuticals
  • (43) DATA INTEGRITY INSPECTION READINESS SUMMIT
    Audit Trail Reviews & Data Integrity Compliance
    Robert J. Wherry, MSc, MS, CPIP, Head – R&D Data Systems QA & Compliance, Takeda
  • 2:30
    Afternoon Refreshment Break
  • 3:00- 4:30
    Select Between Knowledge Exchange Sessions (44-46)
  • (44)
    Equipment Qualification – Fit for Intended Use
    Milan Kilanic, Validation Lead, Alexion Pharmaceuticals
  • (45)
    Using Quality System Elements to Maintain Your Process Validated State
    Gamal Amer, Ph.D. Principal, Premier Compliance Services
  • (46) DATA INTEGRITY INSPECTION READINESS SUMMIT
    Using Validation Sampling Plans for Critical Decisions
    Raul Soto, Senior Principal Software Engineer, Johnson & Johnson Vision Care
  • 4:30
    Close of Conference

Faculty

  • Danny Hernandez, Associate Director, BioMarin

    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.
  • Matthew LaPierre, Data Integrity Program Manager, Ipsen Bioscience

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

Sponsors


  • GOLD




  • 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/
  • 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/
  • 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.

    Kaye equipment has become the standard for helping customers increase validation process efficiency and document the results. The Kaye product range is designed to meet the most demanding industrial requirements for process improvement, thermal validation and reporting. Specializing in providing turnkey system solutions and supporting them with unmatched technical service, we offer a complete range of wired systems, wireless systems, RF-based real-time systems, temperature standards, baths, thermocouples and fittings, all designed to provide the most accurate process measurement available.
    Website: https://www.kayeinstruments.com
  • SILVER




  • 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/
  • 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/
  • 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/
  • 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.

    Since 1996, Novatek International has been a global leader in providing innovative and comprehensive, process-driven software solutions. With 20 years of successful global installations Novatek has developed an extensive base of regulatory knowledge giving you the peace of mind knowing you are in compliance with regulatory guidelines. Your Data is more than just a number. It has the power to drive compliancy and improve your business.
    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/
  • We have expertise in the practical implementation of a wide range of statistical methodologies in all parts of the pharmaceutical product lifecycle.
    Website: https://www.synolostats.com/
  • Global Leader in Paperless Validation
    Website: http://www.valgenesis.com
  • Inspiring Operational Excellence through Best-in-Class CQV Processes
    Website: http://www.validation.org

Partners

Venue

Details

Start:
March 25
End:
March 27
Event Category:

Venue

Wyndham Philadelphia Historic District
400 Arch Street
Philadelphia, PA 19106 United States
+ Google Map
Phone:
(215) 923-8660
Website:
https://book.passkey.com/event/49826319/owner/16417/home

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