• Noteworthy Clinical Trends in Med Device to Watch in 2018

    5 July, 2018 by James Jardine, Staff Writer, MasterControl

    Radical, whirlwind change is a core feature of the medical device industry. A clinical/regulatory expert provides insight into the clinical developments currently shaking up the device world and explains how device companies can adapt and thrive in a burgeoning industry that seems to reinvent itself daily.

    Full story
  • FDA Experts Give Top 10 FDA GMP Inspection Citations for FY 2017, Part 1

    22 May, 2018 by Jerry Chapman, Editor-in-chief, Xavier Health, and GMP Quality Consultant

    Experts at the FDA/Xavier PharmLink conference at Xavier University in March 2018 presented and analyzed the FDA's top 10 drug GMP inspection citations for FY2017 during a panel discussion. The first part of a two-part series.

    Full story
  • The FDA Just Called! Are You Ready for an Inspection?

    27 January, 2016 David R. Butcher, Marketing Communications, MasterControl

    If the U.S. Food and Drug Administration (FDA) called tomorrow to schedule a visit to your facility, would you go into panic mode or would you go on with your day, business as usual? For many, an FDA inspection can be a scary prospect. It can be extremely difficult, and failing it can have significant consequences. With proper preparation, however, the FDA’s call to schedule an inspection doesn’t have to be a nightmare scenario.

    Full story
  • Coming Soon to a Pharma Inspection Near You: The Program Alignment Group (PAG) Plan

    19 April, 2016 Mark Schwartz Of Counsel, Hyman, Phelps & McNamara P.C.

    There have been at least four FDA initiatives, in the works for some time that, in the coming years, will change the way pharmaceutical (and indeed all FDA) inspections are conducted. We think you should know about these initiatives, and how they are likely to affect the way companies prepare for, and deal with, FDA inspections. Today, we are going to discuss the Program Alignment Group (PAG) plan, arguably the least controversial of the four. Over the next few weeks we will discuss the other three programs that are likely to dramatically affect the inspection landscape.

    Full story
  • The FDA Just Completed Its Inspection...Now What?

    12 May, 2016 David R. Butcher, Marketing Communications, MasterControl

    Even after an FDA investigator has completed an inspection at your facility, there’s still plenty of work that remains. At the conclusion of an audit, the inspector will hold an exit interview to discuss observations and present significant findings on a Form 483. What do you do next?

    Full story
  • 3 Areas of Focus When Responding to FDA Inspection Findings

    28 July, 2016 David Butcher, Staff Writer

    When an FDA investigator issues a Form 483 after inspecting your facility, the cited observations should be addressed in writing to the FDA within 15 days, even if the initial response will be preliminary. To prepare an appropriate response to the audit findings and get on the necessary path to mitigate and resolve the identified issues, you’ll want to focus on at least three key areas, according to ARC Experts President and CEO Walt Murray.

    Full story
  • Brave New World: The Mutual Recognition of CGMP Inspections

    9 March, 2017 by Mark I. Schwartz, Director, Hyman, Phelps & McNamara PC

    Last week, the United States and the European Union agreed to recognize each other’s drug cGMP inspections. The agreement reached (see

    Full story