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

Duration: 90 Minutes
21 CFR Part 11 describes the quality standards required of all computer systems used in FDA-regulated industry. This regulation provides basic framework for computer systems used to generate records and data, and used for analysis and presentation.
FDA Audits
Instructor: Mukesh Kumar
Product ID: 500034
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 is 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.

Why Should you Attend:
This seminar 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 password, and audit trails. Case studies will be used to highlight common issues and potential solutions.

Objectives of the Presentation:
  • 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 can 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
Live Session - How it works
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  • Access to the recording is valid only till 6 months starting from the date of purchase.
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes.

Mukesh started his professional career as a research scientist at the NIH, Baylor College of Medicine, Houston, and several premier institutions in India. With more than 11 years of experience in virology, gene therapy, and molecular biology, Mukesh has expertise in biological and combination products. He has been a global Regulatory Affairs Specialist (US, EU, and India) for the last 5 years. He has filed several new-INDs for drugs, biologics and combinations products, NDAs, 510K, PMAs, etc. He has made several hundred FDA submissions, and arranged a number of meetings and responses to FDA comments. In addition, he has had made regulatory submission in the EU and India. Mukesh has reviewed/compiled more than 100 clinical trial protocols and has supervised more than 60 multi-national clinical trials (both under IND and non-IND trials), in the US, Canada, Latin America, Africa, and Asia. In addition to drugs and Biologics, he has extensive experience in medical device and diagnostic product regulatory filings and safety monitoring.

Specialties: Technology transfer, global regulatory strategy, global clinical trials, safety reporting, training, and GLP/GCP audits.

Honors and Awards: US patent awarded "Gene Therapy vectors derived from Sendai virus".

Education: Education: Delhi University - Ph.D., Biochemistry - 1993 – 1997
National Dairy Research Institute - MS, Biochemistry - 1990 – 1993
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