Guest Columns

41. Ensuring Quality In Ventilator Production Scale-Up For COVID-19 4/24/2020

    Chief Editor Louis Garguilo asked Outsourced Pharma Advisory Board member and COO/CSO of Pharmatech Associates, Inc., Bikash Chatterjee, to update our readers periodically on what he is seeing and experiencing during this coronavirus pandemic. This is his first update.

42. Medtech Data Analysis: Techniques to Create Business-Building Insights 4/20/2020

    Combining industry expertise with sophisticated data science methodologies offers medtechs a more precise and detailed understanding of market dynamics, enabling better business decision-making.

43. Stand By To Stand By: Organizational Contingency Planning 4/6/2020

    The coronavirus (COVID-19) pandemic has been a wakeup call, exposing the vulnerability of the global supply chain and the lack of emphasis placed on contingency planning.

     

44. Implementing Data Quality By Design For Improved Data Integrity 4/1/2020

    We must adopt more planning in our data quality activities. This is data QbD in its simplest explanation, and we must include data integrity planning in those activities (e.g., considering how to meet ALCOA requirements).

45. Medical Device Usability Testing In The Age Of COVID-19 4/1/2020

    Organizations striving to validate their medical devices’ human factors performance have a massive new problem on top of testing programs already under attack for improper testing methods and overzealous risk-mitigation practices.

46. How To Combine Quality Management With Risk-Based Monitoring In Clinical Trials 3/31/2020

    It is important to understand why risk-based monitoring (RBM) alone is not enough for a trial to succeed and what the industry can do to extend the use of risk-based strategies to ultimately support improved data quality and increased patient safety in clinical trials.

47. India To Regulate All Medical Devices 3/25/2020

    Expansion of notified device categories is poised to benefit savvy domestic and Western medical device companies by cutting out cut-rate operations.

     

48. Remote Auditing Best Practices For GMP Compliance 3/25/2020

    Every organization that is regulated by the FDA has been adversely affected by the coronavirus (COVID-19) pandemic. This article will focus on remote auditing for good manufacturing practice (GMP) compliance, with a focus on the challenges, opportunities, and best practices for performing remote internal and external audits.

49. Facilitating Great Virtual Meetings During A Pandemic (Or Any Other Time) 3/20/2020

    Even before the global pandemic of the novel coronavirus, virtual meetings were on the rise, With a large percentage of people working from home, it's now a public health imperative. Here's how to facilitate a risk assessment, root cause investigation, or something similar via “virtual facilitation” with team members and subject matter experts scattered around the world.

50. Assessing The Impact Of COVID-19 On Regulatory Interactions, Inspections, & Audits 3/19/2020

    While we have not seen any significant delays in regulatory approval of life science products to date, the impact of COVID-19 on regulatory interactions, inspections, audits, and global health authorities is continuing to evolve.