FDA's Rules for Computer Systems Simplified: Easy, Cheap and Fast Ways to Meet Part 11 Requirements

Event Information
Product Format
Prerecorded Event
90 Minutes
Product Description

Simple, Self-Administered, Practical Solutions to Meet FDA’s Part 11 Requirements

For any organization trying to understand and implement FDA’s Part 11 requirements, there are simply two options:

  • Hire expensive consultants and purchase expensive software
  • Implement self-created systems and live in constant fear of findings of non-compliance during FDA audits.

21 CFR Part 11 describes the quality standards required of all computer systems used in FDA-regulated industry. This regulation provides the basic framework for computer systems used to generate records and data used for analysis and presentation. Computer systems need to meet these requirements at all kinds of FDA-regulated operations such as clinical trial management, laboratory processes, manufacturing and packaging processes, regulatory applications, and clinical site operations. Companies frequently struggle to understand the minimum requirements a given computer system must meet to comply with FDA’s rules.

Good news! In this audio conference, our experts Dr. Mukesh Kumar and Mr. Herman Wong will simplify the regulatory requirements and add practical tips for quick and easy verification of compliance with FDA requirements which can be self-implemented by most organizations with minimum technical expertise.

This audio conference will discuss the basics of Part 11 requirements and practical techniques for evaluation of the current compliance status of a given organization. You will hear about validation requirements, system security protocols, rules for building computer networks, adding new components to network, back-up of data, access control, rules for passwords, and audit trails. Case studies will be used to highlight common issues and potential solutions.

Here are a few highlights of the session:

  • Part 11 requirements by FDA
  • Applicable systems per the FDA
  • Validation of computer systems
  • Network set-up, maintenance, integrity check and security
  • Common elements of Part 11 complaint computer systems
  • Building Part 11 compliant systems bottom-up and top-down.
  • Back-up and re-creating data
  • Verifiable audit trails
  • Electronic signatures and certificates
  • Best practices for using non-networked computers

Who should attend?

  • FDA-regulated labs, clinical trial sites, manufacturers, and sponsors
  • Everyone involved in computer system validation
  • Anyone selecting computer systems intended for FDA regulated environments
  • Information technology professionals responsible for files or network locations
  • Quality professionals who organize, document and verify system compliance
  • Executives evaluating requirements Part 11 compliant systems

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About Our Speaker

Dr. Mukesh Kumar and Herman Wong

Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He and leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in about...   More Info
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