ARTICLES BY ALLAN MARINELLI

• A Real-World Consulting Calamity — 6 Ways It Could Have Been Avoided

  6/15/2020

  Some leaders in the pharma, biopharma, and med device industries believe hiring consultants is quicker and more efficient than hiring a full-time employee. Does this thinking fail to factor in the investment required for thorough recruiting and training to ensure a successful engagement?

• Working With Two Consultants On One QMS Overhaul: What Could Go Wrong?

  5/18/2020

  Some companies in the life sciences mistakenly assume that if they hire multiple consulting firms to establish, manage, or overhaul a quality management system, it will inevitably result in an automatic licensure of their new blockbuster product at a low service cost. This article will discuss just such a scenario. 

• Harmonization Horrors: When Quality System Alignment Goes Wrong

  3/6/2020

  This article is the first in a two-part series explaining how to successfully harmonize disparate quality systems when two companies merge. Here in Part 1, we will focus on what not to do when reconciling two quality systems, providing real-life examples — drawn from the author’s experiences — from each phase of QMS harmonization.