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

    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?

    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

    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.

  • 7 Surefire Ways To Motivate A Life Science Consultant

    Companies in the pharma industry are increasingly hiring consultants to meet the objectives of small to large capital projects. It's important that companies motivate their consultants to their maximum abilities

  • 5 Steps To Set Effective Goals For A Life Science Consultant

    Clients must set appropriate goals before hiring consultants to ensure the project is completed as efficiently and effectively as possible despite the potential obstacles that can obstruct the path of focus. This article will focus on five essential steps to set appropriate goals for a successful client/consultant relationship

  • Initial Engagement With A Life Science Consultant: Common Pitfalls & Best Practices

    Inadequate communication between the consultant and the client, especially at the initial engagement phase, is often not taken seriously enough or addressed sufficiently on both sides.


Allan Marinelli

Allan Marinelli acquired over 25 years of worldwide cGMP experience in Belgium, France, South Korea, China, India, Canada, and the U.S. under the FDA, EMA, SFDA, KFDA, WHO, and other regulators. He is currently the president/CEO of Quality Validation 360 Inc., providing consultation services to the (bio)pharmaceutical, medical device, and vaccine industries. Marinelli has authored peer-reviewed papers (Institute of Validation Technology), and chapters on validation (computer systems, information technology/infrastructure, equipment/process, etc.), risk analysis, environmental monitoring, and cleaning validation in PDA books. He is an associate member of ASQ (American Society for Quality) and a member of ISPE. Marinelli has provided comments to ISPE’s Engineering Baseline guideline documents, including a recent review of the new draft ISPE Good Practice Guide: Data Integrity by Design, projected to be published in 2020. You can contact him at and connect with him on LinkedIn (