ARTICLES BY ALLAN MARINELLI

  • Best Practices In Environmental Monitoring Sampling — Transportation & Analysis
    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
    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
    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
    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
    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
    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
    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

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, vaccine, and food/beverage industries. Marinelli has authored peer-reviewed papers (Institute of Validation Technology) and chapters on validation, risk analysis, and environmental monitoring in PDA/DHI books, and chapters on cleaning validation in PDA/DHI books. In addition, Marinelli published peer-reviewed articles on Pharmaceutical Online, Bioprocess Online, and Outsourced Pharma in 2016, 2017, and 2018. He is an associate member of ASQ (American Society for Quality) and published an article in ASQ titled “Against the Grain, Standing your ground when senior majority rules” in Quality Digest (Aug. 2014). You can contact him at amarinelli360@gmail.com.