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COMPUTER SYSTEMS VALIDATION & DATA INTEGRITY COMPLIANCE CONGRESS

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December 7 - December 9

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This fall, FDA plans to release a draft guidance on Computer Software Assurance!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, CSV and Data Integrity challenges remain high in our rapidly changing environment. In fact, FDA and other regulators continue to find serious findings including; 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
  • Understand FDA’s CSA Expectations and Proposed Draft
  • 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
  • Data Integrity
  • 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

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Faculty

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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

  • 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/
  • 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/

  • 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/

Partners

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Venue

Details

Start:
December 7
End:
December 9
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/50086521/owner/16417/home

Pricing & Registration

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