Part 11 Compliance Simplified: Easy, Cheap and Fast Steps to Meet FDA Requirements

MessageThis Webinar is over
Date Dec 4, 2013
Time 01:00 PM EDT
Cost $249.00
Description :
This webinar will discuss the 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.

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. However, for any organization trying to understand and implement Part 11 requirements, there are only two options: One, hire expensive consultants and purchase expensive software, or implement self-created systems and live in constant fear of findings of non-compliance during FDA audits. In this seminar, we 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.

Areas Covered in 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 Will Benefit:
This webinar will provide valuable information to: 
  • 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
Speaker Profile:
Dr. Mukesh Kumar
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. His key expertise is in regulatory affairs, clinical trials and multinational project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.

Herman Wong
Herman Wong is a Washington DC-based consultant for computer systems in FDA-regulated industry. He has been in the industry for over 12 years and leads the Information Technology department at Amarex, a full service pharmaceutical product development company based in Germantown, MD ( His key expertise is in training of IT personnel in FDA-regulated industry, creating, managing and implementing Part 11 compliant computer systems. Since 2005, Mr. Wong has been evaluating EDC systems for Part 11 compliance at small and big organizations including some of the largest US federal organizations and large pharmaceutical companies.


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