2-Day Virtual Seminar on 21 CFR Part 11, Data Integrity, and Computer System Validation

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The FDA and other Health Authorities worldwide have focused their attention on data integrity. The intent of Computer System Validation (CSV) is to ensure that computerized systems are developed and configured such that data integrity risk is reduced to an acceptable level. In today’s world, a company’s computerized systems may exist as cloud-based services. Such Software-as-a-Service (SaaS) models are hosted remotely and can be quite complex. Unfortunately, many of the companies that the instructor has audited have commercial off-the-shelf systems in place that show evidence of numerous data integrity issues. These issues are the result of either deliberate or inadvertent inadequate configuration and validation. Often SaaS providers are unaware of the regulatory requirements of their customers.

This Computer System Validation Training course is intended to be an introduction to the terminology and documentation requirements and the regulatory basis of CSV in the regulated Life Sciences industries. Although many companies outsource their Information Technology support or rely on cloud-based services, ultimately, compliance responsibility falls solely upon the Life Sciences company. This responsibility also extends to those US companies sourcing their supplies from foreign manufacturers or conducting clinical trials in other countries. As such, it is in the best interest of those responsible for computerized systems to understand the regulatory basis, documentation, testing and controls required to meet regulatory expectations and avoid regulatory action from Health Authorities.

Topics covered in this seminar include the concepts of Part 11 compliance, data integrity and risk management, quality management systems associated with CSV, privacy issues, testing and documentation, and the software life cycle. Techniques for conducting internal audits of computerized system will also be discussed. Several sessions will be conducted as interactive exercises.

This Computer System Validation Training course is intended for Life Science companies such as pharmaceutical manufacturers (both drug substance and drug product), medical device manufacturers, and those companies conducting or sponsoring clinical trials. In addition to these regulated companies, this course will be of value to software vendors and SaaS/cloud providers.

Learning Objectives:

  • Understand the concepts behind 21CFR Part 11
  • Understand data integrity and how it relates to computerized system implementation and usage
  • How to manage a CSV project
  • The components of computer system validation
  • The types of computerized systems
  • Legacy systems and the predicate rule
  • Documentation requirements
  • Computerized system audits
  • Change control requirements
  • Quality Management System requirements
  • Privacy requirements
  • Risk assessments
  • Software life cycle management

Areas Covered :

  • Documentation requirements that demonstrate software validation and computer system validation.
  • The specific requirements associated with local and SaaS/cloud hosting solutions.
  • The importance of validating the quality process and every computerized system used in laboratory, clinical, and manufacturing settings.
  • Data integrity risk assessments
  • How to perform internal audits to verify successful software implementation

Who will Benefit:

This CSV Training Course will benefit those responsible for the selection, implementation, validation, and maintenance of computerized systems in the Life Sciences industry. These include regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GMP / GCP / GLP applications.

  • Regulatory Affairs
  • QA/ QC managers and supervisors
  • IT Managers
  • Project Managers
  • Manufacturing Managers
  • Software vendors and suppliers
DAY 01(8:30 AM - 4:30 PM EDT)
  • 8:30 AM - 8:59 AM: Registration, Meet & Greet.
  • 9:00 AM - 10:00 AM:
    • Training objectives review, expectations, and scope.
    • Defining computer software validation (CSV) by breaking down 21 CFR §820.70(i)
  • 10:00 AM - 10:15 AM: Break
  • 10:15 AM - 12:00 PM:
    • What is a regulated software system anyway?
    • Exercise: Is it or isn’t it?
    • An overview of the software validation regulatory landscape
      • U.S. FDA
      • EU
      • AAMI
      • ISO
      • ICH
      • Other
    • A review of software validation terms
    • Electronic records / electronic signatures (21 CFR Part 11; EU GMP Guide, Annex 11)
  • 12:00 PM - 1:00 PM: Lunch
  • 1:00 PM - 2:30 PM:
    • The software validation document set
      • Planning
      • Defining
      • Building
      • Validating
      • Releasing
  • 2:30 PM - 2:45 PM: Break
  • 2:45 PM - 4:30 PM:
    • The software validation document set (continued)
    • Incorporating the software validation document set into your lifecycle model
      • V-model
      • Iterative methods (e.g. Agile Scrum, XP, ADD)
    • Exercise: What’s wrong with this requirement? What’s wrong with this test case?

DAY 02(8:30 AM - 4:30 PM EDT)
  • 8:30 AM - 8:59 AM: Recap of Day 1 Q&A
  • 9:00 AM - 10:00 AM:
    • Change management and keeping software in a validated state
      • Change management, configuration management, defect management
      • Impact analysis
      • Skipping back through the lifecycle
  • 10:00 AM - 10:15 AM: Break
  • 10:15 AM - 12:00 PM:
    • Special considerations
      • Spreadsheets
      • Legacy software
      • Off-the-shelf software
      • Software-as-a-Service (SaaS)
      • Cloud-hosted systems
      • Compilers
  • 12:00 PM - 1:00 PM: Lunch
  • 1:00 PM - 2:30 PM:
    • Special considerations:
      • Cybersecurity
      • Artificial intelligence / machine learning (AI/ML)
      • Defending software validation in audits/inspections
  • 2:30 PM - 2:45 PM: Break
  • 2:45 PM - 4:00 PM:
    • Current and future regulatory enforcement trends by U.S. FDA and other global competent regulatory authorities
    • The upcoming Computer Software Assurance Guidance from U.S. FDA
  • 4:00 PM - 4:30 PM: Course recap Q&A
Seminar (Price/Register)
Seminar Fee Includes:
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

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  4. Email it to cs@compliance.world

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