FDA Forced to Evolve its Toolkit Amidst Mounting Inspection Backlog during the COVID-19 Pandemic

by Lara Bartlett | Dec 9, 2021 | SMART Life Science

  Impact of COVID-19 on FDA Inspections The COVID-19 pandemic profoundly disrupted the FDA’s inspection capabilities, prompting concerns raised by the U.S. Congress regarding the backlog in assessing pharmaceutical manufacturing facilities[i]. This...

Internship Report

by KVALITO Consulting | Sep 28, 2021 | SMART Career

Saadia Raymode I started my internship at KVALITO in June 2021, just after my final year exam for my University degree in Malaysia, and then continued it in my home country – Mauritius. Despite not being able to go to the office, I always felt motivated to wake up in...

You’re invited! Data Integrity Workshop in Barcelona, Spain – March 01, 2019

by Magdalena Kurpierz | Jan 31, 2019 | SMART Events

If you would like to join this Data Integrity Workshop, you can get your ticket via Eventbrite or send us an e-mail: julia.lopez_guimet@kvalito.ch. Please note that participation is limited to 30 We are looking forward to meeting you in...

Data Integrity: Risks and Solutions

by Dr. Anna-Lena Hürter | Apr 19, 2018 | SMART Life Science

To ensure patient health and product quality, adhering strictly to Good Manufacturing Practice (GMP) is essential. One part of GMP, which is increasing in importance within the last few years due to higher FDA focus, is Data Integrity. Data Integrity means the overall...

You’re invited! Data Integrity Breakfast

by Magdalena Kurpierz | Nov 3, 2017 | SMART Events

When? November 21, 2017, 8:30 AM Where? KVALITO HQ, Dornacherstrasse 101 4053 Basel – CH Agenda: 8.30 AM – 9.10 AM Networking & French Breakfast Sponsored by KVALITO 9:10 AM – 9:15 AM Welcome & Introduction Magdalena Kurpierz (CEO &...