Software Validation: Avoiding FDA Warning Letters and Consent Decree

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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