FDA Compliance and Mobile Applications

01:00 PM EDT | 10:00 AM PT | 12:00 PM CT Duration 90 Minute

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

"Hear By Carolyn Troiano industry reviewer for 21 CFR Part 11, the FDA’s (ER/ES) regulation. along with computer system validation and risk management/compliance at a number of Fortune 100 firms. "

Understanding of computer system validation planning, execution and management concepts

Description

Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacture, testing, distribution and management of a product in the pharmaceutical, biotechnology, medical device, tobacco and other regulated industries.
As a major part of the computer system validation effort, an FDA-regulated company must ensure that all validation documentation is prepared in accordance with the Agency’s guidelines.  Having the right documents and preparing and managing them according to best industry practices is critical to validation success.

Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization.  During the past 30 years, best practices that have been developed will ensure that the cost of building and managing a computer system validation program will be minimized.

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

You should attend this seminar if you are responsible for planning, executing or managing the validation of a system governed by FDA regulations that incorporates mobile software or devices into the system structure.

Upon completion of this session, attendees will have an understanding of computer system validation planning, execution and management concepts, in terms of how these efforts are to be adequately documented to meet FDA requirements.  They will understand the steps required for documenting the validation process, along with the key documentation associated with maintaining the systems in a validated state, while minimizing costs.  The attendees will have a good grasp of how to leverage these practices across all systems by creating a standardized program.

Areas Covered

•           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. riskUnderstand 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

Who will Benefit

Professionals in the following industries may also benefit from the content:
      •           Pharmaceutical
      •           Medical Diagnostics
      •           Biotechnology
      •           Tobacco and Related (Vapor, e-Cigarette, Cigar, etc.)
      •           Animal Health

Any other FDA-regulated industry, plus any Life Science Consulting or Contracting firm
      •           Information technology managers and analysts
      •           QC/QA managers and analysts
      •           Clinical data managers and scientists
      •           Compliance managers
      •           Lab managers and staff
      •           Automation analysts
      •           Computer system validation specialists
      •           GMP training specialists
      •           Business stakeholders and individuals who are responsible for computer system validation planning,                          execution, reporting, compliance, and audit
     •            Consultants working in the life sciences, tobacco and related industries who are involved in computer                         system implementation, validation and compliance

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.


Speaker Profile

Carolyn Troiano

Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.

During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA’s electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.

Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.

Back to Top