Once upon a time, an unfamiliar man wrote to me on LinkedIn saying that he has offer for me. Never in a million years would I have thought that this would open the door to a completely new world for me. In April 2022, I started my...
SMART Life Science
SMART Corporate Citizenship and Social Responsibility
Cell and Gene Therapy Products: Ancillary Materials and their Qualification
Table of Contents Ancillary or Raw Materials AM qualification Conclusion Regulations References These days, research and development of many pharma companies are focused on Cell and Gene Therapies, which bring hope for many...
The Applicability of FDA’s Computer Software Assurance Guidance to Data Integrity
As technology progresses, new approaches to software inspection continue to be found. In the webinar ‘Understand the Applicability of FDA’s Software Assurance Guidance to Data Integrity’ (linked below), a new approach to validation is...