Computer & Software Validation – Data Integrity Compliance

This fall, FDA plans to release a draft guidance on Computer Software Assurance!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...
Develop, Implement and Maintain Risk-based Programs Enterprise-wide

This fall, FDA plans to release a draft guidance on Computer Software Assurance!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 FDA’s Proposed CSA Draft Guidance – Understand the Impact of Impending Changes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.

Source: www.kenx.org