FDA Compliance for Mobile Applications

In this webinar, we will describe FDA requirements for mobile applications, 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.

Eleonora Babayants
Instructor:
Eleonora Babayants
Duration:
60 Minutes
Product Id:
503212
Access:
6 months

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Price Details
$190 Recorded
$390 Corporate Recorded
Price Detail Options
Overview:

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.

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 Session:

  • 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


Speaker Profile
Eleonora Babayants is a Galaxy Consulting Founder and President, She is a documentation management professional and hands-on consultant with over 25 years of experience in documentation and records management, document control, regulatory compliance, internal and external auditing, electronic document management systems, information governance, and change management.

Eleonora's past work includes development and implementation regulatory compliance processes and procedures, leading implementation and administration of document control systems in full compliance with regulatory requirements, enabling enterprise search, improving systems information architecture, creating and implementing users training programs.

She led electronic document management systems selection and deployment, administered and supported these systems, web information portals, knowledgebase applications, recommended and implemented re-structuring of the content and the information architecture of these systems. She worked very closely with IT to do feasibility assessment and to capture users' requirements.

She wrote technical documents and created documents templates. Eleonora's experience spans multiple industries including biomedical, pharmaceutical, and medical devices companies.


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