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Laboratory Data Integrity Compliance Congress

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Governance | Compliance | Validation

June 25 - June 27

San Diego, United States

Recent FDA Warning Letters Highlight Laboratory Data Integrity Deficiencies

 

FDA has issued many Warning Letters emphasizing data integrity non-compliance primarily in the  analytical environment. 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 Laboratory Data Integrity Compliance Congress is headed to San Diego and showcases the protocols, methodology and actions necessary to avoid regulatory action.

 

Choose from Over 20 Tutorials Addressing Today’s Top Analytical Challenges

 

  • Develop, Implement and Maintain Data Integrity Protocols Enterprise-Wide
  • Learn the Methodology and Techniques Used to Identify Inaccuracies
  • Conduct an Laboratory Audit Enterprise-Wide
  • Ensure the Reliability and Completeness of Analytical Data
  • Identify and Investigate Root Causes of Integrity Lapses
  • Cybersecurity Risk Management Implementation and Continued Verification
  • Perform a Risk Assessment for  Data Deficiencies
  • Understand Requirements and How to Handle Laboratory Audit Trails

 

This Conference is Co-Located with Analytical Method Development, Validation and Transfer Summit

  • Adopt a Systematic Approach for Method Robustness with Effective Design of Experiments (DoE)
  • Evaluate Performance through Analyzing Samples from In-Process through the Finished Product
  • Define and Develop the Content and Scope of Analytical Procedures Program
  • Conduct Suitability Tests and Establish Acceptance Criteria for System Functionality Excellence
  • Develop a Roadmap for Analytical Methods Validation
  • Evaluate Characteristics through Statistical Analysis of Validation Data
  • Development and Validation of a Stability-Indicating Analytical Method
  • Learn How to Perform Risk-Based Evaluations
  • Post Marketing Change Control Procedures for Approved NDA, ANDA and BLA
  • Handle the FDA Laboratory Methods Verification Process
  • Effectively Manage Transfer Studies and Protocols

 

Personnel in the Following Environments Should Attend:

  • Validation
  • QA/QC
  • Scientist
  • Chemist
  • Laboratory Management
  • Regulatory Affairs
  • Data Integrity

 

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

Agenda

  • 12:00
    Conference Registration
    Coffee and Lite Snacks On-the-Go
  • 1:00
    Chairperson’s Opening Remarks
  • 1:15
    Lifecycle Management Concepts to Analytical Procedures: A Compendial Perspective
    Horacio N. Pappa, CQE, Ph.D., Director – General Chapters Global Science and Standards Division, U.S. Pharmacopeia
  • 2:00
    The MHRA Guidance on Data Integrity and the Major Differences with FDA’s Draft
    Steven S. Kuwahara, Ph.D., Principal Consultant, GXP BioTechnology, LLC
  • 2:30
    FDA Insight on Analytical Method Development for Biologics
    FDA invited
  • 3:15
    Afternoon Refreshment Break
  • 3:45
    Overcome Top Challenges to Build Quality Systems in Analytical and Stability Laboratories
    Kim Huynh-Ba, Executive Director, Pharmalytik
  • 4:15
    The Convergence of Laboratory Quality Systems
    Carmen Medina, MPH, PhD(c), VP Techinical Services, PAREXEL International, Former FDA Investigator
  • 5:00
    KENX/Temple Scholarship Award & Welcome Reception
  • 7:00
    Coffee and Lite Breakfast
  • 7:30-8:15
    Select Between Knowledge Exchange Sessions (1-2)
  • (1)
    Effectively Manage Method Transfer Studies
    Bette Monnot-Chase, Director, CMC & Quality, Asklepion Pharmaceuticals
  • (2)
    Analytical Data Integrity, it all Matters, but what Really Matters NOW?
    Jay Chenier, Data Integrity Consultant, formerly, Process Owner, Global Computer Validation, GlaxoSmithKline
  • 8:30-10:00
    Select Between Execution and Master Planning Workshops (A-B)
  • (3)
    Develop a Roadmap for Analytical Methods Validation
    Norman Fraley, Executive Director, Frolich Institute
  • (4)
    Laboratory Data Integrity – Successful Implementation of Policy, Governance, Validation and Risk Management
    Eileen Cortes, Associate Director for QA and Validation, BioMarin
  • 10:00
    Networking Refreshment Break
  • 10:30-12:00
    Select Between Knowledge Exchange Sessions (5-6)
  • (5)
    Implementation of Continued Process Verification in the Analytical Laboratory
    Anthony Chikere, Sr. Mgr. Process Validation/Cleaning and CPV, Bayer HealthCare, Berkeley
  • (6)
    Master Your Laboratory Metrics Through Data Integrity
    Carmen Medina, MPH, PhD(c), VP Techinical Services, PAREXEL International, Former FDA Investigator
  • 12:00
    Focus Group Luncheons (7-8)
  • (7)
    Advanced Laboratory Professional Master Class
    Eileen Cortes, Associate Director for QA and Validation, BioMarin
  • (8)
    Impact of Human Factors on Data Integrity in the Laboratory
    Norman Fraley, Executive Director, Frolich Institute
  • 1:15-2:45
    Select Between Knowledge Exchange Sessions (9-10)
  • (9)
    Development and Validation of a Stability-Indicating Analytical Method
    Peju Odunusi, Group Leader, Stability, Abbott Vascular
  • (10)
    New Data Integrity Solutions for Old Laboratory Equipment
    Eric Collier, Discipline Lead Automation and IT, Commissioning Agents, Inc.
  • 2:45
    Afternoon Refreshment Break
  • 3:15-4:45
    Select Between Knowledge Exchange Sessions (11-12)
  • (11)
    Statistics for the QC Scientist
    Tara Scherder, Partner, SynoloStats LLC
  • (12)
    Understand and Prevent Data Integrity Behavioral Non-Compliance
    Jay Chenier, Data Integrity Consultant, formerly, Process Owner, Global Computer Validation, GlaxoSmithKline
  • 4:45
    Close of Day Two
  • 7:00
    Coffee and Lite Breakfast
  • 7:30-8:15
    Select Between Knowledge Exchange Breakfasts (13-14)
  • (13)
    Lab Data Integrity - Risk Management Tools & Techniques
    Byron Mattingly, Ph.D., Software Division Chair, American Society for Quality
  • (14)
    Advanced Data Integrity Master Class
    To Be Announced
  • 8:30-10:00
    Select Between Knowledge Exchange Sessions (15-16)
  • (15)
    System Functionality Excellence via Suitability Tests and Acceptance Criteria
    Steven S. Kuwahara, Ph.D., Principal Consultant, GXP BioTechnology, LLC.
  • (16)
    Preparing for and Performing a Laboratory Data Integrity Audit
    Steve Thompson, Senior Manager, Professional Services, ValGenesis, Inc. – South San Francisco, CA
  • 10:00
    Mid-Morning Refreshment Break
  • 10:30 – 12:00
    Select Between Knowledge Exchange Sessions (17-18)
  • (17)
    Establishing Validation for an Analytical Method to Monitor Organic Impurities
    Kim Huynh-Ba, Executive Director, Pharmalytik
  • (18)
    Implement Data Integrity Risk Management
    Byron Mattingly, Ph.D., Software Division Chair, American Society for Quality
  • 12:00
    Focus Group Luncheons (19-20)
  • (19)
    Evaluate Analytical Validation Characteristics through Simple Statistical Analysis
    Junghae Scott, Director QC, Relypsa, Vifor Pharma Group Company
  • (20)
    How to Use Cloud Computing in an Analytical Regulated Environment
    John Hannon, Business Lead Automation and IT, Commissioning Agents, Inc.
  • 1:15-2:45
    Select Between Knowledge Exchange Sessions (21-22)
  • (21)
    Adopt a Systematic Approach for Method Robustness with Effective Design of Experiments (DoE)
    Tara Scherder, Partner, SynoloStats LLC and Katherine Giacoletti, Partner, SynoloStats LLC
  • (22)
    Cybersecurity, Data Integrity & Validation – Addressing Malicious Threats to the Life Science Industry
    Steve Thompson, Senior Manager, Professional Services, ValGenesis, Inc. – South San Francisco, CA
  • 2:45
    Afternoon Refreshment Break
  • 3:15-4:45
    Select Between Knowledge Exchange Sessions (23-24)
  • (23)
    Performance By Analyzing Samples from In-Process Through the Final Product
    Steven S. Kuwahara, Ph.D., Principal Consultant, GXP BioTechnology
  • (24)
    Data Integrity of Automated Laboratory Equipment and Systems
    Rashida Ray, President, Array Validation Quality and Compliance (AVQC), Inc.
  • 4:45
    Close of Conference

Faculty

  • Jay Chenier, Data Integrity Consultant, formerly, Process Owner, Global Computer Validation, GlaxoSmithKline

    Mr. Chenier is a leader in the Global Computer Validation organization currently on secondment with R&D automating data integrity controls for the next generation of analytical platforms. This includes developing a GxP lifecycle for use of Agile software development practices. He has 26 years of experience including leading the GSK implementation of Annex 11. More recently, he led adoption of the MHRA, FDA (draft) and WHO data integrity guidance documents into policy, procedures, communications and training.
  • Anthony Chikere, Sr. Mgr. Process Validation/Cleaning and CPV, Bayer HealthCare, Berkeley

    Dr. Anthony Chikere is an experienced scientist with over 15 years of experience in different areas of Biopharmaceutical production including: process development, process monitoring and control, process validation and quality assurance. Since 2017, he is responsible for managing the Continuous Process Verification (CPV) program at Bayer HealthCare in Berkeley.
  • Eric Collier, Discipline Lead Automation and IT, Commissioning Agents, Inc.

    Mr. Collier is an IT professional with more than 25 years of experience in CSV and the Software Development Lifecycle. His first introduction to computer system validation occurred in the early 1990’s as a software engineer working on Department of Defense (DOD) projects. These projects introduced him to the software engineering standards from which many of our current CSV best practices are derived.
  • Eileen Cortes, Associate Director for QA and Validation, BioMarin

    Eileen Cortes is an Industrial Engineer and MBA professional with over fifteen years of experience in the biotech and pharmaceutical industry. Currently driving the computerized system global validation program as the QA CSV Associate Director at BioMarin.
  • Norman Fraley, Executive Director, Frolich Institute

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

    Katherine has worked as a statistician in the Pharmaceutical industry for over 17 years and has expertise across the product lifecycle, from product and process development through validation and commercial supply, as well as all stages of clinical development from First in Human through licensure and beyond. She holds a Master of Statistics from North Carolina State University, with a focus in biostatistics. Katherine lives and works in the Philadelphia suburbs with her husband and daughter and 2 cats, and in her spare time is a dancer and a teacher of Scottish dancing.
  • John Hannon, Business Lead Automation and IT, Commissioning Agents, Inc.

  • Kim Huynh-Ba, Executive Director, Pharmalytik

    Kim is an accomplished author and speaker of the compliance and quality areas, both domestic and internationally. She is the editor of the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” (2008) and “Pharmaceutical Stability Testing to Support Global Markets” (2010) published by Springer. She is currently working on a manuscript of “Analytical Chemistry: an introduction to pharmaceutical analysis,” expecting to be available late 2018. She can be contacted at kim.huynhba@pharmalytik.com.
  • Steven S. Kuwahara, Ph.D., Principal Consultant, GXP BioTechnology

    Steven S. Kuwahara, Ph.D., is principal consultant at GXP BioTechnology, LLC (www.gxpbiotech.org) in Sunnyvale, CA. Steve has more than 30 years experience supervising quality control department dealing with drugs, biologics, HCT/P, and nutraceuticals. He has supervised animal facilities and testing laboratories that operated under GLP rules and also those operating under GMP and ISO standards. He may be reached by e-mail and by phone at 408-530-9338.
  • 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.
  • Carmen Medina, MPH, PhD(c), VP Techinical Services, PAREXEL International, Former FDA Investigator

    Ms. Medina uses over 30 years of FDA experience to support an array of international clients in their preparations for successful Pre-approval, GMP, GCP and combo-device inspections. She was a former Commissioned Officer in the United States Public Health Service and a PAI Investigator with the FDA, where she led an international group within Team Biologics and helped usher in the new medical device QSR regulations. Over the past 28 years, she has assisted with the development, successful approval, and commercialization of hundreds of products, including some of the largest pharmaceutical and biotech brands and bio-generics. See her textbook on Amazon: Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics.
  • Bette Monnot-Chase, Director, CMC & Quality, Asklepion Pharmaceuticals

    Bette has a strong background in drug development in the areas of analytical method development, stability, formulation, validation, and vendor management. Her main responsibilities included stability, product development and associated analytical testing, as well as preparation of regulatory CMC documents for global filings. Working for small Pharma that adopted a virtual model - outsourcing all CMC activities to third party vendors, Bette has extensive experience managing the need of her projects and the vendor’s needs, which is necessary to delivery high quality analytical methods, robust formulation and critical stability data to support the product in a global clinical or commercial marketplace.
  • Peju Odunusi, Group Leader, Stability, Abbott Vascular

    Dr. Peju Odunusi is an analytical R&D professional with over 23 years of experience in the pharmaceutical and medical device industries. She has technical expertise in method development and validation, stability support for all phases of product development, method transfer, submissions, audits and has successfully established analytical and stability groups. She is also very passionate about mentoring.
  • Horacio N. Pappa, CQE, Ph.D., Director – General Chapters Global Science and Standards Division, U.S. Pharmacopeia

    Dr. Pappa has been with USP since 2003. He hold the position of Principal Scientific Liaison at the Documentary Standard Division of the USP. He is the scientific liaison to the Expert Committees on Physical Analysis, Chemical Analysis and Statistics. Horacio earned his Ph.D. in Pharmaceutical Chemistry from the University of Buenos Aires. He has authored many publications and peer-reviewed articles and is a frequent speaker and instructor on topics related to Chromatography and Validation. Prior to joining USP, he worked in the pharmaceutical industry in QA/QC. Horacio held the position of assistant professor of Quality Control in the Faculty of Pharmacy at Buenos Aires University, and Executive Secretary of the Argentine Pharmacopeia in the period 1997-2001. He is a Quality Engineer certified by the American Society for Quality.
  • 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.
  • Tara Scherder, Partner, SynoloStats LLC

    Tara has over 25 years of experience in the chemical and pharmaceutical industries as a statistician, process engineer, and master black belt. She has functioned as both an in-house and external statistical consultant to drug substance and drug product teams across the product lifecycle for the spectrum of product platforms. As partner at SynoloStats, she passionately shares the opportunity for patient and business benefit through the combination of statistics and process. Tara earned a BS degree in Chemical Engineering from the University of Pittsburgh and a MS degree in Statistics from Carnegie Mellon University.
  • Junghae Scott, Director QC, Relypsa, Vifor Pharma Group Company

    Ms. Junghae Scott is a Director of Quality Control at Relypsa in Redwood City, California (a Vifor Pharma Group company). Ms. Scott has 30 years of industry experience in CMC, analytical development, and quality control covering Pharma, Biotech, Medical Device, and Combination Products from start-ups to Fortune 500 companies. She received her Master Degree in Chemistry at University of San Francisco.
  • Steve Thompson, Senior Manager, Professional Services, ValGenesis, Inc. – South San Francisco, CA

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

Sponsors

  • GOLD


  • ValGenesis

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


  • Bahnson

    Bahnson Environmental Specialties (BES) designs and manufactures a diverse product line of controlled environmental chambers that maintain precise conditions for clients' research, development, and manufacturing processes. BES has expanded from a respected regional company to a national leader in chamber design, on-site construction, and performance qualifications. Our 45 -year reputation is built on component quality, tolerance integrity, and an approach to engineering that exceeds even the most rigid requirements. Welcome to a Bahnson level of chamber precision.
    Website: http://www.eschambers.com
  • Novatek

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

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


  • 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

Partners

Venue

Details

Start:
June 25
End:
June 27
Event Category:
Website:
https://www.kenx.org/events/lab-data-integrity-san-diego-feb-2018/

Venue

The Bahia Resort Hotel
998 W Mission Bay Dr
San Diego, CA 92109 United States
+ Google Map
Phone:
(858) 488-0551
Website:
http://bahiahotel.com/

Pricing & Registration

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