Software Validation: Avoiding FDA Warning Letters and Consent Decree

Instructor: Mukesh Kumar
Product ID: 703653
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Nov-2014

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Read Frequently Asked Questions

As one among the most leading causes for warning letters and consent decrees, software validation and its compliance are essential to keep your business ready for FDA audits and inspections. Learn best practices to conform to FDA software validation requirements in this webinar with a leading FDA and regulatory affairs expert.

Why Should You Attend:

Computerized manufacturing and quality systems are frequently cited by FDA auditors to be deficient in adequate validation leading to FDA 483s, warning letters and consent decrees. Software validation issues with computerized systems are responsible for multiple product recalls as well. During FDA audits, improper or ineffective software validation can lead to findings of deficient quality systems.

This webinar 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. Case studies will also illustrate the common FDA audit findings for software validation.

Areas Covered in the Webinar:

  • FDA software validation requirements
  • Common types of software that require validation
  • Review of FDA warning letters and consent decrees related to software
  • Common FDA audit findings for software validation
  • Best practices to ensure software compliance

Who Will Benefit:

  • IT/QA personnel
  • Internal auditors
  • External auditors
  • Consultants
  • GMP and QSR personnel
  • Regulatory affairs personnel
  • Senior executives of FDA-regulated firms
  • People investing in such companies

Instructor Profile:

Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He 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 multi-national project management for medicinal and diagnostic products. He has been involved in over 100 clinical trials in more than 40 countries, has made hundreds of US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has made regulatory submissions in the EU, Taiwan, Korea, China, Canada, countries in South America, Australia, and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe, North and South Americas and Asia.

Dr. Kumar 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 in several professional and academic organizations worldwide. Dr. Kumar has a PhD in Biochemistry and is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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