GUEST COLUMNISTS

  • Tools And Best Practices For Trending Environmental Monitoring Data

    Environmental monitoring (EM) trending is an essential component of the EM program and can be used to evaluate the overall health of the facility in terms of microbial control. Part 1 of this series looked at the regulations and guidelines around EM. This article discusses tools and best practices for using the trends to ensure that an efficient environmental monitoring program is established.

  • Biopharma Cold Chain Logistics 101

    Cold chain logistics can be complex and intricate. Maintaining the integrity of controlled-temperature products requires holistic consistency between design and development, manufacturing and packaging, qualification and validation, cold storage, transportation, and monitoring as the product moves from its point of origin to the end user.

  • Why Adjusted Risk Likelihood Should Displace The Risk Priority Number

    While the RPN primarily represents a risk event’s severity, perhaps a more important attribute to focus on is the risk event’s likelihood of occurrence. In this provocative article, Mark Witcher, Ph.D., proposes an adjusted risk likelihood rating approach that emphasizes a risk event’s likelihood of occurrence.

  • An Introduction To Trending In Environmental Monitoring Programs

    Trending environmental monitoring (EM) data is a regulatory requirement. However, it is useful in obtaining significant information about the facility. Trends can help determine if your facility is in a state of microbial control and relay the data to facility management in a meaningful format. In this two-part series, Crystal Booth of PSC Biotech looks first at the regulations and guidelines around EM. 

  • FDA Inspections: Are Changes On The Horizon?

    A year into the pandemic, the FDA is still conducting only limited inspections in the U.S. and evidence has emerged of a significant inspection backlog that could compromise the safety and quality of the U.S. drug supply. Kalah Auchincloss of Greenleaf Health provides a brief timeline of inspection-related events over the last year, discusses the impact, and examines the changes that we might expect as the FDA begins to shift back to normal operations.

  • Life Sciences Dealmaking Aims At Early Stages Amid COVID-19

    Life sciences companies remain unabated when it comes to creatively making deals during the COVID-19 pandemic, particularly among those targeting biopharma companies with early-stage assets.This article highlights takeaways from the KPMG 2021 Healthcare & Life Sciences Investment Outlook, which tallied 1,138 acquisitions, licensing, and R&D deals in 2020.

  • Complying With Batch Release: Auditing Electronic Batch Records

    This article presents some advice for auditing electronic batch records to assess their current good manufacturing practice (cGMP) status. This is useful in the qualification stage and essential once the electronic record system is in operation. 

  • Medicare Braces For Expanded Use Of High-Cost CAR T-Cell Therapy

    The Centers for Medicare & Medicaid Services (CMS) established a new reimbursement rate for inpatient CAR T-cell delivery in 2021 designed to more closely reflect the true costs of care and address the financial losses experienced by many healthcare institutions. This article delves into details on this and also discusses another significant change for 2021.

PHARMA ONLINE WHITE PAPERS

  • Metal Detection, X-Ray Inspection Or Both?

    This white paper will help food and pharmaceutical manufacturers decide on which inspection technology to invest in to ensure the quality and safety of their products. Metal Detection, X-ray Inspection or Both summarises the pros and cons of each technology and guides you through the decision making process.

  • Business Continuity Program: Maintain Operations During Crises
    5/5/2020

    Get insights into implementing a robust business continuity management program that can help secure supply, reduce risks, and maintain quality in manufacturing operations, through a crisis situation.

  • Development Pathways For ATMPs: Virus Safety Challenges And Regulatory Perspective
    6/11/2019

    There is an increased risk of viral contamination in settings where ATMPs are prepared, making it critical to understand the contamination risks and the solutions available to control them.

  • Key Equipment Sourcing Strategies For CMOs
    1/16/2020

    There are many reasons that a product-owner elects to outsource product manufacturing to a toll or contract manufacturer.

  • How Buffer pH And NaCl Affect Size Exclusion Chromatography
    4/22/2020

    Using a design of experiments approach, this study describes the effect of buffer pH and NaCl concentration on proteins purified by size exclusion chromatography.

  • Achieving A F.A.I.R. Data Management Strategy
    3/23/2021

    Recently many industry leaders have been highlighting the problems of not having F.A.I.R. data. For example, a recent report estimates that data that is not findable, understandable or has incomplete metadata introduces inefficiencies and negatively impact research quality, ultimately costing the European economy in excess of €26 billion per year. In this white paper, we explore what the F.A.I.R. principles mean in practical terms for your R&D data management strategy before describing how IDBS enables organizations to make their scientific data Findable, Accessible, Interoperable and Reusable and mitigate the costs of not being F.A.I.R.

PHARMACEUTICAL ONLINE CONTENT COLLECTIONS

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 In this roundtable Q&A, industry experts from AstraZeneca, Takeda, Biogen, and NSF Health Sciences share insights on important topics related to human performance in pharmaceutical operations — offering insight into how forward-thinking organizations treat “human error” in the workplace.

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