Kimberly Colasanti

Kimberly Colasanti

Company: Baxter BioPharma Solutions

Job title: Senior Manager – Regulatory Affairs


Workshop D: Submission Pitfalls & Strategic Planning for Regulatory Success 9:00 am

Discussing the importance of strategic planning in regulatory submissions to avoid wasted time and increase the chances of successful approval Highlighting common pitfalls in regulatory submissions, featuring insights into detrimental factors observed by regulatory bodies Exploring different approaches, processes, and methods that may impact submission outcomes and discussing strategies to avoid pitfalls for a smoother…Read more

day: Pre-Conference Track 2 AM

Best Practises for Streamlining Your Documentation Process to Save Time Whilst Complying with Regulatory Requirements 2:00 pm

Implementing best practices to streamline documentation processes, striking the right balance between efficiency and satisfying regulatory requirements, ultimately saving valuable time Delving into the challenges associated with validating changes for audits, offering insights and strategies to overcome hurdles and maintain compliance in a dynamic regulatory landscape Highlighting the benefits of tools like Confluence and GitHub…Read more

day: Day One

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