• 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. 

  • Harmonious Harmonization: How To Get Quality System Alignment Right

    This article is the second in a two-part series explaining how to successfully harmonize disparate quality systems when two companies combine. Part 1 shared horror stories — drawn from the author’s experiences — illustrating what NOT to do during each phase of QMS harmonization. Here in Part 2, we look at case studies in which companies got it right, bringing together parallel quality systems in a way that increased the probability of success.

  • 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.

  • Best Practices In Environmental Monitoring Sampling — Transportation & Analysis

    The process of establishing a defendable environmental monitoring (EM) sampling plan during performance qualification can be broken into six phases. This article discusses the final two phases.

  • Sampling Preparation & Execution Best Practices For Environmental Monitoring

    The process of establishing a defendable environmental monitoring (EM) sampling plan during performance qualification of a new facility can be broken into six phases. This article will discuss the sampling preparation phase and sampling execution phase.

  • 3 Prerequisites To Establishing An Environmental Monitoring Sampling Plan

    This article is the first in a three-part series describing an engineering approach to establishing an environmental sampling plan for a new pharmaceutical or biopharmaceutical manufacturing facility. The series assume the facility has just been built and no manufacturing of batches have been run.

  • 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.

  • A Quality Validation Risk Management Approach To Establishing Sampling Plans

    The biopharmaceutical industry is continuously undergoing organizational changes intended to better support the healthcare industries while maintaining quality and reducing cost. This article will illustrate how manufacturers can add value to their operations by using a quality validation risk management approach for the development of sampling plans. Establishing a quality validation risk management approach for all pharmaceutical processes would increase the probability of successful outcomes for both the companies producing the products — by helping to meet regulatory requirements — while better contributing to the quality of healthcare for patients.


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 (