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Computer & Software Validation – Data Integrity Compliance

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Computer & Software Validation Implement a CSV Program Aligning with FDA’s Proposed Computer Software Assurance Guidance / Data Integrity Program Implementation Data Management and Controls * Quality Culture * Human Error Reduction

June 24

Virtual, United States

This fall, FDA plans to release a draft guidance on Computer Software Assurance! Are you prepared? To this day, Computer Systems Validation, Software Assurance and Data Integrity challenges remain high in our rapidly changing technology environment. In fact, FDA and other regulators continue to find serious findings in all of these areas. KENX is proud to present this virtual training that helps you master innovative processes, techniques and compliance trends to make an immediate impact in your organization.

 

Top Reasons to Attend

  1. FDA’s Proposed CSA Draft Guidance – Understand the Impact of Impending Changes
  2. Computer Systems Validation – Develop, Implement and Maintain a Risk-based Approach
  3. Software Assurance – Align Your Program with FDA Thinking
  4. Machine Learning – Learn Artificial Intelligence Validation Strategies
  5. MS Excel – Overcome the Challenges of Spreadsheet Validation
  6. Pharma 4.0 – Know the impact of Digitalization and IoT to Validation
  7. Data Integrity – Build a Program from the Ground Up
  8. Human Behaviour – Understand the Impact and Transform the Culture
  9. DI Gap Analysis – Identify Root Cause and Implement Corrective Action
  10. Audit Trail Review – Implement an Effective Process

 

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.

Agenda

  • 10:15 AM EST
    Webinar Host Opening Remarks
    Howard Wilensky, Executive Director, KENX
  • 10:30 AM – 12:00 PM EST
    Implementing a CSV Program that Aligns with the FDA’s New CSA Guidance
    Kevin Martin, Senior Director & Managing Partner, Azzur Group
  • 12:00 – 12:15 PM EST
    Break
  • 12:15 – 1:45 PM EST
    Software Quality Tools to Enable SDLC Modernization
    Raechelle Raimondo, Executive Director - Global Systems Assurance, Allergan Jason R. Tepfenhardt, Co-Founder / CEO, Tx3
  • 1:45 – 2:00 PM EST
    Break
  • 2:00 – 3:30 PM EST
    Data Integrity by Design – Applying the Critical Elements of Data Management and Controls that Ensure Data Integrity Excellence
    Travis Frick, Head Data Integrity and Analytics, GSK
  • 3:30 – 3:45 PM EST
    Break
  • 3:45 – 5:15 PM EST
    Understand Impact of Human Factors on Data Integrity – Create the Culture You Desire
    Matthew LaPierre, Specialist – CSV and Data Integrity Compliance
  • 5:15 PM EST
    Close of Virtual Training

Faculty

  • Kevin Martin, General Manager & Managing Partner Azzur Group LLC

    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.
  • Raechelle Raimondo, Executive Director - Global Systems Assurance, Allergan

    Mrs. Raimondo is an experienced leader with over 20 years of Life Sciences industry experience in the implementation of compliant and business driven global systems using a risk-based approach. By applying strategic and critical thinking she has successfully established practical policies and practices for regulated & non-regulated computer systems to achieve quality business outcomes. In today’s rapidly changing world of technology, she has shifted her focus and passion to collaborate with others to effectively implement Computer Software Assurance (CSA) and automation tools within the pharmaceutical industry.
  • Jason R. Tepfenhardt Managing Partner / Co-founder, Tx3 Services

    With over 20 years of Life Sciences industry experience, Jason has been successful in applying technology to deliver innovative solutions that derive real value from the computer systems validation life cycle. At Tx3 he is responsible for business operations and developing strategic solutions and services that enable Life Sciences companies to meet regulatory requirements for computerized systems in a more cost effective and efficient manner. Prior to Tx3, Jason spent 9 years co-managing the Healthcare and Life Science Practice at Genilogix / Avnet. He has also held positions as an Analytical Chemist, Validation Specialist and Director of Quality. He holds a BS in Environmental Science from William Patterson University and an MBA in Technology Management from Drexel University.
  • Travis Frick, Head Data Integrity and Analytics, GSK

    Technical Operations and Quality Executive with extensive experience managing transformational change in business critical settings. Hands on leader who enjoys working in a fast pace environment. Experience includes working in a global environment, execution of strategic priorities, and developing talent within the organization. Innovative change manager who drives metric-driven quality enhancements, process improvements and operational efficiencies.
  • Matthew LaPierre, Specialist – CSV and Data Integrity Compliance

    Mr. LaPierre is an industry expert and an experienced data integrity project manager. He has a thorough understanding of not only the foundation and principles of data integrity but also the project management tools and resources needed to execute a truly effective data integrity program in the life science industry.

Sponsors

  • 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/

Venue

Details

Date:
June 24
Event Category:

Venue

Remote
Virtual, United States

Pricing & Registration

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