Contributing Editors

41. What’s The Role Of Intuition When Making QRM Decisions? 2/28/2022

    In Part 1 of this 2-part series, this author explained how to effectively set up your quality risk management (QRM) program for pharma and medical devices. In this article, he explains how to implement that program. For such a numbers-based field, there is still an important role for using your intuition to make QRM decisions.

42. 6 Tips To Ensure Your NDA/BLA Is Ready For FDA Review 2/25/2022

    When preparing a marketing authorization application for an NDA or a BLA, one aspect that is easily overlooked by small start-ups and mature multi-product drug sponsors alike is verification that all commitments made to the FDA have been completed and that evidence of this has been submitted to the agency.

43. What Are Risk Appetite & Risk Tolerance In Pharma & Medical Devices? 2/23/2022

    This article describes and differentiates risk appetite and risk tolerance and discusses why these two concepts are foundational to how we make risk-based decisions in pharma and medical devices. Also covered are a spectrum for risk appetite, best practices for risk communication, and events and conditions that can shape risk appetite and tolerance.

44. Factory/Site Acceptance Testing & Commissioning Responsibilities 2/22/2022

    Execution of factory acceptance testing (FAT) and site acceptance testing (SAT) is a business-critical activity when it comes to commissioning of a new system or equipment. FAT is conducted at the equipment manufacturer’s site and SAT is conducted at the final site of installation. This article shares best practices.

45. How To Set Up An Effective Quality Risk Management Program 2/16/2022

    The author of this article has taught courses on quality risk management (QRM) and its implementation as well as seen it in action in many companies. This article, Part 1 of a 2-part series, shares some of his observations and lessons learned in setting up an effective QRM program.

46. Data Management: 5 Best Practices For Emerging Biotechs 2/14/2022

    Whether your ambitious upcoming pharma startup or biotech has its sights set on being the world’s first in your field, or a lucrative exit through a strategic company sale, starting out with good data management practices will set you up for success for the future you envision.

47. Pharmaceutical Quality Compliance In 2022: Data Is Paramount 2/11/2022

    Pharma quality and compliance leaders must anticipate potential manufacturing issues before they happen by leveraging risk-based methodologies, continuously monitoring their systems, and tracking the profusion of data generated during the process. This article outlines the potential of data and analytics to improve quality performance.

48. ICH And USP <1220>: Implementing A Quality By Design Analytical Framework 2/9/2022

    The International Council for Harmonization (ICH) and the United States Pharmacopoeia (USP) are finalizing draft guidelines that describe a new paradigm for analytical development based on the quality by design (QbD) approach used for pharmaceutical development. The new chapter will become official on May 1, 2022.

49. Facilities Remediation, Renovation & Reconstruction: When Does It End? 2/7/2022

    We sit at the beginning of 2022 amid the industry’s frantic and hurried effort to acquire, expand, and prepare more aseptic plant capacity — and to make it useable, compliant, and productive. This article provides a deep-dive on planning and design for your project, including walls, floors, ceilings, interstitial and mechanical spaces.

50. The Talent Shortage In Biopharma Demands A Creative Solution 2/2/2022

    The demand for new talent in the biotech industry was already reaching new heights before the COVID pandemic, and now it is even more obvious. Complicating the dilemma is the move toward Pharma 4.0. The industry will need talent that can operate in new business models that are more complex.