Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

Join us for a webinar on December 14 for a discussion of the webinar 

Who will Benefit

Personnel in the following roles will benefit:

  • Information Technology Analysts
  • QC/QA Managers
  • QC/QA Analysts
  • Clinical Data Managers
  • Clinical Data Scientists
  • Analytical Chemists
  • Compliance Managers
  • Laboratory Managers
  • Automation Analysts
  • Manufacturing Managers
  • Manufacturing Supervisors
  • Supply Chain Specialists
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
  • Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
  • Auditors engaged in the internal inspection of labeling records and practices

Webinar Takeaways

  • Gain an understanding of how mobile applications should be handled when performing validation work
  • Understand the best practices for maintaining a mobile application in a validated state
  • Discuss the best practices necessary to ensure all systems, including mobile applications, are validated appropriately
  • Learn how to develop the appropriate computer validation strategy when dealing with mobile applications to ensure a good balance of cost vs. risk
  • Understand how to effectively document the process of computer system validation, and maintain current information about the various systems in your organization, as they begin to include mobile applications
  • Learn how to gain information about trends in validation of mobile applications, as industry progresses and new best practices emerge
  • Understand some of the key “pitfalls” to avoid when applying the concepts of computer system validation to mobile applications
  • Q&A

Overview

How computer system validation can be applied to mobile applications subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and 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.

We will detail the key areas of focus, including security, access and change control, along with the documentation that is required to create a complete and compliant validation package in a cost-effective manner.

This topic is focused on the use of mobile applications to process data regulated by FDA. These applications may be used to collect, analyze, transfer, report, or otherwise manage data that will be submitted to FDA and/or must be available for FDA review upon inspection or audit.

Mobile applications may be used in any area of an FDA-regulated company. Functional areas where FDA-regulated data is typically processed include, but are not limited to Quality Laboratories, Manufacturing, Supply Chain/Distribution, Adverse Event Reporting, Post-Marketing Surveillance. Systems may also be used to monitor and/or control FDA-regulated processes and equipment, handle product labeling, product lot control, clinical trial and trial sample management, and many other processes.

As technology changes, we need to adapt our approach to computer system validation for systems regulated by FDA to ensure that we take into account all controls that need to be in place, whether technical or procedural. Mobile devices have the added complexity of being small, portable and vulnerable to both physical and logical mishap or calculated attack.

Why Should You Attend

This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.

You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system.  

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Faculty Carolyn Troiano

Faculty Carolyn Troiano


Carolyn Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries.  She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs

Choose a Purchase Options

$199

Live Webinar - Single Participant 90-mins

You get one log-in for the live 90-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email

$499

Group Up to 5 Participants ( MP3 Download Free )

You get 5 log-in for the live 90-minute webinar for all the participant, presentation materials , MP3 Download and the opportunity to ask questions by phone and email

$299

Recorded Access Corporate Group

You'll have access to group log-in for an archived recording of the entire 90-minute webinar, including the Q&A period, for 1 location. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

$389

MP3 Download - Training DVD

Within 48 hours delivered - Lifetime Access ,Audio recording of a webinar and reference manual delivered by download. Listen anytime on any compatible device.

$289

Live + Recorded Access - Single Participant

You get one log-in for the live & recorded 90-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email