ARTICLES BY JOANNA

• Education Vs. Experience: Which Is More Important In GMP Operations?

  8/6/2018

  When looking at most job descriptions in GMP companies, they now require a college degree. This leads to the question: Are we overvaluing educational degrees and undervaluing experience?

• Someone, Everyone, Or No One: Who Owns Quality? (And Who Should)

  5/7/2018

  Who is ultimately responsible for quality/the quality management system at a life science company: (A) all personnel working for the company, (B) the quality assurance department, or (C) company management (including top executives)? Note your answer somewhere before reading this article.

• #MeToo & Time’s Up — Parallels To Reporting Of GMP Compliance Issues

  2/2/2018

  #MeToo and Time’s Up are spotlighting illegal, unethical, improper, and undesirable behaviors. Illegal, unethical, improper, and undesirable behavior exists in the GMP world, too, and we’ve been warned as well.

• Flip The Org Chart: Rethink Where A Pharma Company's Focus Should Be

  7/31/2017

  I had given a good manufacturing practice (GMP) refresher session in a company whose mantra was efficiency and speed. After the session, a manufacturing operator talked to me about employees’ frustration with the situation, saying, "Why don't people understand that if we focus on doing things right, efficiency will come?"

• 9 Steps To Train Your Personnel To Think Beyond The SOP

  5/10/2017

  We need to teach people how to think again. Then, we need to encourage them to think on a day-to-day basis so that they’re comfortable with it when a problem arises that requires out-of-the-box, beyond-the-SOP thinking. 

• Are You (Inadvertently) Teaching Your Personnel To NOT Think?

  4/10/2017

  We control our processes through our SOPs, as we should. But where many of us have gone wrong is that we teach people to blindly follow the SOP — and if the SOP doesn’t say it, they shouldn’t do it. 

• Do You Make This Critical Root Cause Analysis (RCA) Mistake?

  11/14/2016

  In FDA-regulated industries, root cause analysis (RCA) is perhaps the most frequently used tool for identifying the source of a good manufacturing practice (GMP) deviation and determining an appropriate corrective and preventive action (CAPA). Yet, inadequate RCA is also one of the most common citations found in observations issued by FDA and other international regulatory bodies.

• The 5 Basic Tenets Of Data Integrity — And How Failures Occur

  7/14/2016

  With all the data integrity issues highlighted in regulatory agency inspections over the last several years, it seems very few people are familiar with the court case that set the legal precedent for data integrity standards. This is largely the reason why we see so many data integrity issues today.

• Human Error: How To (Accurately) Identify & Address It Using Performance Models

  5/18/2016

  After giving a recent course on reacting to human error, one of the attendees sent me a variety of questions about how to apply the human performance models we discussed in FDA-regulated environments.

• Applying Human Performance Models In FDA-Regulated Environments

  4/15/2016

  This article will provide regulatory context, address confidentiality concerns, and walk through an application based on an actual FDA 483.