Regulatory Compliance Featured Articles

  1. What Should You Do After An FDA Inspection?
    3/29/2019

    The FDA inspected your firm, and one or more FDA Form 483 inspectional observations were noted by its team. This article provides guidance on how to minimize or avoid additional enforcement actions.

  2. Beyond Human Error: Are Blunt- Or Sharp-End Decisions More Important In The Life Sciences?
    3/27/2019

    Decisions made upstream in the supply chain can have enormous repercussions downstream at the bedside or in the home, where medications are administered. How do we guarantee that the big and seemingly small decisions being made with each batch manufactured will be the “right” ones when there is so much inherent variability around us?

  3. Pharma Industry Braces For A No-Deal Brexit
    3/22/2019

    Chaos reigns supreme in London at the moment, as British Prime Minister Theresa May struggles to find a graceful way for the United Kingdom to exit from the European Union (EU). Meanwhile, pharmaceutical manufacturers must prepare for multiple potential outcomes, including a “no-deal” (or “hard”) Brexit.

  4. Putting The “Process” Into Process Characterization
    3/19/2019

    Done correctly, Process Characterization reduces the risk of manufacturing failures and regulatory delays. Scientists at the AbbVie Bioresearch Center (ABC) have established a platform approach to Process Characterization that has been proven effective as it has been used to support the approval of several marketed products.

  5. FDA Guidance On Premarket Pathways For Combo Products — What It Does (And Doesn’t) Say
    3/13/2019

    Last month, the FDA published the draft guidance “Principles of Premarket Pathways for Combination Products.”  The document describes what a combination product is and how to interact with the FDA when developing a combination product, and it identifies some of the principles the agency uses in determining what type of premarket submission should be made. 

  6. Raising The Bar: The Silver Lining Of FDA Commissioner Gottlieb’s Exit
    3/7/2019

    It was the announcement many have been dreading — but expecting — for several months now. Dr. Scott Gottlieb, 23rd Commissioner of the FDA, announced his decision to step down after 663 days (22 months) on the job. The news is sure to raise concerns for many. But I think the biggest surprise is how equally sad thought-leaders within the agency will be to say goodbye.

  7. Become A (Better) Facilitator For Risk Assessment And Root Cause Analysis
    2/28/2019

    When SMEs, management, and others gather to perform a risk assessment or a root cause analysis on a failure, they’re sure to achieve the desired outcome, right? Perhaps for a simple risk assessment or investigation, but success is not very likely for one that is even moderately complicated. That’s where a skilled facilitator is needed.

  8. Bridging Chasms In Equipment Qualification And Software Validation
    2/27/2019

    Equipment qualification seems like a straightforward process. However, things usually go awry when gathering a validation team and defining and documenting the intended use and system requirements. 

  9. Why Data Integrity Is Impossible Without A Quality Culture
    2/19/2019

    For successful establishment and sustainability of a quality culture, “the mindset and behavior... must start at the top and be emulated by individuals at all levels and in all functions within the company.”

  10. How To Write An Effective Validation Master Plan
    2/6/2019

    A validation master plan outlines the principles involved in the qualification of a facility, defining the areas to be validated, and provides a written program for achieving and maintaining a qualified facility.