FDA Compliance for Mobile Applications

Instructor: Eleonora Babayants
Product ID: 706490
Training Level: Intermediate to Advanced
  • Duration: 60 Min
Attend this webinar to understand the FDA guidance for mobile applications. We will discuss the key areas that are most important during inspection and audit, including security, data integrity, validation, training, and documentation. We will pay special attention on the issue of validation of mobile applications.
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Why Should You Attend:

Mobile applications must be compliant with GxP/GMP requirements for IT systems. FDA applies regulatory authority over mobile applications just like over IT systems which are involved in the development, manufacture, and sale of regulated products. Many companies struggle with understanding how to avoid major mistakes and inspection risk where mobile applications are concerned. FDA issued guidance on mobile applications.

In this webinar, we will describe FDA requirements for mobile applications. We will review FDA guidance for mobile applications. We will discuss the key areas that are most important during inspection and audit, including security, data integrity, validation, training, and documentation. We will pay special attention on the issue of validation of mobile applications

The workspace is becoming increasingly mobile. Mobile computing enables access from anywhere. Employees and customers expect and demand that all business applications support mobility. Companies need to be able to deliver mobile experience and the ability to provide access to content from mobile devices. Content and systems must be optimized for mobile devices.

Employees working in the field must be able to access content from their mobile devices. Employees use mobile devices to collaborate on docs, take meeting notes, create presentations, and collect data in the field.

FDA recognizes the functions and need for mobile applications, their potential benefits and on the other hand potential risks to public health. Therefore GxP/GMP requirements for IT systems must be applied to mobile applications.

In this webinar, we will describe FDA requirements for mobile applications. We will review FDA guidance for mobile applications. We will discuss the key areas that are most important during inspection and audit, including security, data integrity, validation, training, and documentation.

We will pay special attention on the issue of validation of mobile applications. We will talk about the appropriate validation strategy to achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.

This webinar will provide a good overview of the best practices that deliver the best results including the most critical and cost-effective methods, techniques and tools.

The attendees will have a good understanding of how to use these practices across all IT systems by creating a standardized program for applying the SDLC to mobile applications in accordance with FDA requirements.

Areas Covered in the Webinar:

  • FDA regulatory oversight over mobile applications
  • FDA guidance on mobile applications
  • GxP/GMP requirements for mobile applications
  • Validating mobile applications
  • Best practices for maintaining a mobile application in a validated state

Who Will Benefit:

  • Quality Assurance
  • Documentation Managers
  • Records Managers
  • Document Control
  • Compliance
  • Medical Affairs
  • IT Professionals
  • Data Managers
  • Safety Managers
  • Systems Administrators
  • Databases Administrators
  • Regulatory Affairs
  • Laboratory managers and supervisors
  • Production managers and supervisors
  • Auditors

From Regulated industries such as Pharmaceutical, Medical Devices, Food, Cosmetics, any other regulated industry and not regulated industries; any industry

Free Materials:

  • Presentation
Instructor Profile:
Eleonora Babayants

Eleonora Babayants
Founder and President, Galaxy Consulting

Galaxy Consulting Founder and President Eleonora Babayants has many years of GxP/GMP hands-on experience in regulated industries. She worked with quality assurance and compliance officers to develop and execute compliance strategies and programs. She participated in the implementation of compliance requirements.

Her many years’ experience includes regulatory compliance, internal and external auditing, change management, documentation and records management, document control, electronic document management systems, information governance, IT systems management and validation.

Eleonora’s past work includes development and implementation of regulatory compliance policies, processes, and procedures, leading implementation and administration of document control and document management systems in full compliance with regulatory requirements, designing and implementing electronic documents workflows, leading enterprise content management initiatives, enabling enterprise search, improving systems information architecture, creating and implementing users’ training programs.

Eleonora ensured document management systems compliance with regulatory requirements. She collaborated with users to develop positive and productive approaches to regulatory compliance, coordinated, prepared, and participated in internal and external audits including FDA audits.

Eleonora’s experience spans multiple industries including biomedical, pharmaceutical, and medical devices companies.

Topic Background:

The workspace is becoming increasingly mobile. Mobile computing enables access from anywhere. Employees and customers expect and demand that all business applications support mobility. Companies need to be able to deliver mobile experience and the ability to provide access to content from mobile devices. Content and systems must be optimized for mobile devices.

Employees working in the field must be able to access content from their mobile devices. Employees use mobile devices to collaborate on docs, take meeting notes, create presentations, and collect data in the field.

FDA recognizes the functions and need for mobile applications, their potential benefits and on the other hand potential risks to public health. Therefore GxP/GMP requirements for IT systems must be applied to mobile applications.

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Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR

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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