LABORATORY DATA INTEGRITY
COMPLIANCE CONGRESS

AGENDA

1:30 PM
USP 1220: A Compendial Perspective

Leonel M. Santos, LMS Consulting, Formerly, Analytical Chemist, Senior Compendial Liaison, and Director of Chemical Medicines at U.S. Pharmacopeia



Lifecycle Management of Analytical Procedure and Methods Validation – FDA Perspective

Peju Odunusi, Ph.D., Owner, Pj Pharmaceutical Consulting



Use QbD and DoE Approaches to Produce Robust Methods

Steven S. Kuwahara, Ph.D., Principal Consultant, GXP BioTechnology



3:00 PM
Data Integrity in the QC Lab — Warning Letters and Trends

Robert J. Wherry, MSc, MS –Quality Compliance & Systems, RDQ Data Systems, Takeda Pharmaceuticals



Ensure Analytical Procedures and Methods are Fit for Purpose when Data Integrity is Essential

Heather Longden, Snr Marketing Manager and Isabelle VuTrieu, Pharmaceutical Market Development Manager, Waters Corporation



Data Integrity in the Lab – Common Issues and Solution

Sanjay Agrawal, President and CEO, CIMINFO Software



7:30 - 8:15 AM
Data Integrity Compliance Principles

Sheba Zaman, Head of Product Specialists and Training Services, Novatek



8:30 - 10:00 AM
The Critical Data Integrity Factor — Human Behavior

Matthew LaPierre, Data Integrity Specialist



10:30 - 12:00 PM
QC Lab Data Integrity Program Best Practice

Chris Wubbolt, Principal, QACV



12:00 PM
Compliance Strategies for the QC Analyst

John J. Long, Ph.D., Analytical Integrator, Biologics QC, Teva Branded Pharmaceuticals



1:15 - 2:45 PM
Create Quality Cultures that Identify and Address Risks

Steve Thompson, Director Industry Solutions, ValGenesis



3:15 - 4:45 PM
QC Audit Trails — Documents, Reports and Reviews

Sheba Zaman, Head of Product Specialists and Training Services, Novatek



7:30 - 8:15 AM
Keeping Data Integrity in Mind While Qualifying Instruments

Heather Longden, Senior Marketing Manager, Waters Corporation



8:30 - 10:00 AM
Understanding Data Pedigree to Assess Data Integrity and Quality Data Risk

Ronald D. Snee, Ph.D., Founder and President, Snee Associates, LLC.



10:30 - 12:00 PM
Data Integrity Process Mapping

Matthew LaPierre, Data Integrity Specialist



12:00 PM
How to Prepare for & Handle Laboratory Inspections

Robert J. Wherry, MSc, MS –Quality Compliance & Systems, RDQ Data Systems, Takeda Pharmaceuticals



1:15 PM - 2:45 PM
Conduct a Data Integrity Audit and Gap Assessment

Steve Thompson, Director Industry Solutions, ValGenesis



3:15 - 4:45 PM
Implementing a Data Integrity Program from the Ground Up

Azzur Group



SPONSORS




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Azzur Group

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/
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CAI

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
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Ellab

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/




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CIMINFO Software

CIMINFO’s LabMonitor software brings legacy lab applications into Part 11 compliance. Other solutions include Part 11 controls for Spreadsheets, Document and Quality Management, Training and an Inventory System for data integrity assessments. With over 20 year of experience, CIMINFO products are trusted by hundreds of FDA-regulated firms in over 30 countries. Website: https://part11solutions.com/
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H&A Scientific

H&A Scientific, Inc. is a scientific software development firm specializing in pharmaceutical industry support. We develop, validate, and market quality computing systems for scientific data acquisition, processing, and data management. We have been creating programs for the laboratory since 1992. Our products have been designed under our Quality System to adhere to the current GAMP guidelines. We develop Quality Software products based on the needs of pharmaceutical companies subject to the constraints and compliance of the Food and Drug Administration (FDA). Our flagship product, SLIM, is a commercial off-the-shelf solution for total management of a company's drug stability program. Website: http://www.hascientific.com/en/
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Neva Analytics

Neva Analytics provides contract analytical services to the pharmaceutical and biotech industries. Our laboratory works with pharmaceutical companies and compounding pharmacies during all stages of development to help bring their products to market. We provide custom analytical services tailored to our client's needs. Founded on over 20 years of pharmaceutical industry experience, we know what it takes to develop methods, test and release your product. Your time is valuable so we pride ourselves on quickly responding to your analytical needs. We set the standard for quickly responding to our client’s requests and providing the highest quality results so our clients can advance critical therapies. Website: http://nevaanalytics.com/
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Novatek International

Novatek International provides a new breed of all-encompassing, process-driven LIMS and other software solutions that target the pharmaceutical, biotech and other health-care industries. Our unique portfolio of out-of-the-box, easy to use software solutions features specialized modules that help you manage all aspects of your quality environment with less effort and time. Novatek delivers solutions that go beyond LIMS for total enterprise wide automation. Website: https://ntint.com/
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QACV

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/
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Waters Corporation

From the everyday consumer to scientists in the laboratory, we all rely on accurate information to make critical decisions. Waters Corporation is the world's leading specialty measurement company focused on improving human health and well being through the application of advanced analytical science technologies. Website: http://www.waters.com

Recent FDA Warning Letters Highlight Laboratory Data Integrity Deficiencies


Most data integrity non-compliance are cited in the GMP laboratory. 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

 

Laboratory Data Integrity Compliance Congress Highlights Include:

  • Develop, Implement and Maintain Data Integrity Protocols in the GMP Lab
  • Conduct a GAP Analysis and Identify Root Causes
  • Conduct an Laboratory DI Audit Enterprise-Wide
  • Ensure the Reliability and Completeness of Analytical Data
  • Discover the Impact of Human Behavior
  • Implement Risk Management Protocols, Perform Assessments and Continually Verify
  • Prepare for and Handle FDA DI Investigations
  • Understand Requirements and Handle Audit Trail Reviews

 

Maximize Your Training! This Event is Co-located with Analytical Procedures and Methods Validation:

  • 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.

Pricing & Registration

For An Additional $995, You Can Earn 1.5 Graduate Credit Hours Towards Temple’s RAQA Graduate Program! For More Information, Email INFO@KENX.ORG, Call 856-281-7134 or Register Above.