GUEST COLUMNISTS

  • Selecting The Best Human Factors Method For Your Medical Or Drug Delivery Device Evaluation

    A robust human factors process has become critical to product optimization and market competitiveness for medical devices and drug delivery devices, but not all companies have the resources, funding, or time to conduct such user studies. This article from Genentech's head of human factors engineering examines the three major categories of evaluation that you should consider, the pros and cons of each, and how to select study participants.

  • The 8-Step Checklist To Write Effective Investigation Reports

    It’s always best to prevent the need to investigate a non-compliance, but if you experience a non-compliance, it’s necessary to quickly and effectively perform an investigation. The investigation report needs to be clearly understandable to anyone reviewing the report, and hopefully you'll also learn enough to make sure the non-compliance doesn't recur.

  • FDA Releases Guidance On CMC Changes To An Approved Application: Certain Biological Products

    At the end of June, the FDA released a new guidance to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application. This article summarizes the guidance.

  • Patent Transparency For Biologics & Biosimilars: The Revamped Purple Book

    The FDA recently updated the “Purple Book” — a database containing information about all licensed biological products — to include, for the first time, patent information relating to biologics as well as FDA regulatory exclusivity information.

  • How To Enhance “Operational Learning” In Biopharma

    According to conventional wisdom in biopharma, operational learning is derived from existing practices, including inspections, audits, deviation investigations, and gemba walks. What is often missing is the necessary understanding of the “how.” This article provides advice, as well as lessons learned from Takeda and Biogen.

  • Emerging Biopharma: Your Next 2 Geographic Markets To Tackle After The US

    While the majority of the world’s drug development and innovation are underwritten by the United States, emerging drug developers should not overlook these two major regions of the world that represent volume, profit, ingenuity, and growth. 

  • Navigating DSCSA Implementation: Key Requirements & 4 New FDA Guidances

    In the U.S., you're grappling with how to set up a fully interoperable electronic system for securing and tracing products across industry sectors per the Drug Supply Chain Security Act (DSCSA) by Nov. 2023. Here's how to navigate the key requirements, as well as the FDA's four new guidances on the subject released in June.

  • 5 Foundations Of Lean Leadership For Pharmaceutical & Medical Device Professionals

    Every life sciences company, now more than ever before, is on a journey to provide greater returns to stakeholders by manufacturing products at better quality and lower cost, which is the aim of lean manufacturing. However, many people forget about the cultural and leadership aspects of lean, which at its foundation are responsible for the success or failure of a lean transformation. 

PHARMA ONLINE WHITE PAPERS

PHARMACEUTICAL ONLINE CONTENT COLLECTIONS

20_11_PO_MovingBeyondHumanError_Ebook_300x200

 

 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.

More Content Collections

LIFE SCIENCE CONNECT SPOTLIGHT JOB OPENING: TARSUS

tarsus-job1

Tarsus, a late clinical-stage biopharmaceutical company focused on the development and commercialization of therapeutic candidates to address large market opportunities, is hiring a VP Manufacturing Operations & Supply Chain Management. Reporting to the COO, you will be accountable for the overall CMC development, manufacturing and supply chain strategy for clinical and commercial supply of drug substance, drug product and IMP.

Sound interesting?

Read the Job Posting to learn more.

TRAINING COURSES