SCOPE AND OBJECTIVES
Our client, a global pharmaceutical contract development and manufacturing organization, was in need of a staffing partner to provide a high volume of direct hire resources. The client’s internal talent…
As applications for technology in healthcare continue to emerge, innovative tools and top organizations are driving the evolution of the industry. Leading technology company Amazon…
We have all heard of breakthroughs in the ability to bring the power of artificial intelligence (AI) and the scale of big data and cloud computing to the life sciences, pharmaceutical, and biotechnology industries. These advancements include…
SITUATION
Our client, a leading manufacturer of genomic profiling tests, received audit observations with FDA 21 CFR Part 820 and ISO 13485 as related to CAPA (Corrective and Preventive Action) management. Being relatively…
