Software Validation- Avoiding FDA Warning Letters and Consent Decree

Duration: 90 Minutes
Computerized manufacturing and quality systems are cited by FDA auditors to be poor in adequate validation leading to FDA 483s, Warning Letters and Consent Decrees.
Form 483
Instructor: Mukesh Kumar
Product ID: 500460

Software validation issues with computerized systems are responsible for multiple product recalls as well. Improper or ineffective software validation leads to finding of deficient quality systems during FDA audits. This seminar will provide practical tips for achieving FDA-acceptable software validation of general computer systems and computerized equipment. Case studies will be used to highlight common mistakes and possible solutions.

Why Should you Attend:
To learn more about FDA software validation requirements and common types of software that require validation

Objectives of the Presentation:
The objectives of the presentation are to know more about:
  • Reviewing FDA Warning Letters and Consent decrees related to software.
  • Common FDA audit findings for software validation
  • Best practices to bring software into compliance
Who can Benefit:
  • IT/QA personnel
  • GMP and QSR personnel
  • Regulatory affairs personnel
  • Senior executives of FDA-regulated firms
  • People investing in such companies
Live Session - How it works
  • Username and Password will be sent to you 24 hours prior to the webinar
  • Presentation handouts in pdf formate will be mailed to you
  • Login to the session using the username and password provided to you
  • Get answer to your queries through interactive Q&A sessions via chat
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve
  • Get certification of attendance.
Recorded Session - How it works
  • A link will be provided to you upon purchase of the recorded session
  • Please click on the link to access the session
  • Presentation handouts in pdf formate will be mailed to you
  • Get certification of attendance.
$375
Recorded Session for one participant
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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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