ReadySetGo: Life Sciences Localization

This course is not currently scheduled. 

This course is intended for those who are new or newer to life sciences localization. If you are looking for a more advanced curriculum, please consider taking the Life Sciences Localization Master Class.

Course Overview

This course will enable participants to understand and manage the content localization process in a life sciences regulatory context. Participants will learn about the regulatory requirements impacting the localization process and best practices to effectively achieve compliance with these requirements.

This course will focus on selected challenges, pitfalls and experiences “from the trenches” that have proven to be critical to ensure that products can be released to market efficiently, effectively, and in a way that’s compliant to required standards.

Target Audience

• Client or LSP Localization Project Managers, Localization Program Managers
• Marketing directors and managers
• Communication directors and managers
• International project and program managers

Participants from any industry and any size of business will be welcome. Multinationals, scaleups and startups can send delegates to attend this course.

Key Takeaways

• An understanding of the regulatory landscape impacting localization
  • Medical Device Regulation
  • In-Vitro Device Regulation
  • Clinical Trial Regulation
  • Drug regulatory submissions process
  • 21 CFR Part 11
  • Data security for digital products
• Best practices to successfully localize your content in this regulatory context
  • Understanding unique challenges of regulatory environment
  • Culture of quality and transparency
  • Qualification of translation resources
  • Technologies to support achievement of regulatory compliance
  • Leveraging measurable translation quality to achieve success
  • Designing efficient, value-oriented workflows
  • Validating translated content
  • Meeting FDA translation certificate requirements

Please note: recording or republishing any part of the class session is prohibited. We do this in order for students to be able to speak and share experiences freely with the instructor and their fellow classmates in a comfortable and safe environment without fear that something they say might later be made public.

Blog

Did you know that the instructor for this course takes an in-depth look at life sciences localization in her blog?  Check it out here.

About Your Instructor

Sonia Monahan is a global content and localization strategist, with a specialization in process and technology optimization and regulatory compliance. With 30+ years of leadership experience in the localization industry, Sonia brings a wealth of knowledge and a proven track record of success in delivering exceptional content creation and localization solutions. Her core focus is supporting life sciences customers achievement of their corporate objectives for time to market, quality and cost, while ensuring compliance to all necessary regulations.

Sonia is the Principal of Peak Global Solutions, LLC. She has a BA in German and an MEd from Lesley College and is certified as a Lean Six Sigma Blackbelt and is a quality auditor for ISO 9001, 13485, 17100, and 18587. Her book, The Definitive Guide to Measured Translation Quality, co-authored with Jason Arnsparger, was published in 2014.