Thank goodness for diligent regulators. Read on, and be horrified. The US Food and Drug Administration (FDA) recently inspected a testing facility outside Los Angeles and found serious concerns about the quality and integrity of the data produced there. In its warning letter, which is publicly posted online, the agency’s inspectors outlined the objectionable conditions … More This FDA warning letter is appalling
This past Saturday I sat for the Certified Quality Improvement Associate (CQIA) exam. I passed and now I can draw on this body of knowledge and cite this certification for the rest of my career in quality. In this article I will explain what this certification is. I will describe my experience in preparing for … More How I boosted my knowledge and credibility with the Certified Quality Improvement Associate certification
The New Rules of Work: The Modern Playbook for Navigating Your Career, by Alexandra Cavoulacos and Kathryn Minshew (2017) I stumbled upon this book after reading a positive review and was very impressed. It is a well-organized and focused presentation of some of the content of themuse.com, an online career resource. The authors understand the … More Career Book Review: “The New Rules of Work”
Reviewing a scientific report is a great privilege. You are among the first to see new knowledge without having to do the sometimes-tedious investigative work itself. And if you’re like me, you might feel the joy of learning something new. When reviewing, I encourage you to do two things. Firstly, commit to applying a method, … More How to review a scientific report
The FDA regularly issues warning letters regarding data integrity. Now, the agency is encouraging companies involved in GMP to get on top of these issues with regular audit trail review. You may have read some FDA or EU publications relating to data integrity and audit trails and wondered how they may apply to your … More How to review audit trails
Over the years, the spreadsheets circulating in a testing or manufacturing company can become a real zoo. This presents a regulatory and client-relevant problem. It is important that you take a risk-based approach and validate your spreadsheets according to their use. A spreadsheet used for dosing, reporting data or in dilutions may be a “legacy … More How to validate a spreadsheet
Independence is a prominent theme in the field of Quality. At its heart is the separation of doing and checking. The example of the Hubble Space Telescope Why is independence important? Consider the Hubble Space Telescope. It is a major achievement of science. But the first images it returned were found to be blurry! After … More Independence: the importance of separating the checking from the doing
[This article pertains to nonclinical laboratory studies.] Suppose you were just hired in a Quality role (QA specialist, tester, auditor, inspector, reviewer, technical data specialist, etc.). During your orientation and training people bandy about such acronyms and initialisms as the GLPs, the OECD, the QAU, and 21 CFR 58. You probably have … More What is a quality assurance unit?
Quality is a profession at the heart of our advanced, industrialized, information society. It is also a field that is full of opportunity. Job boards are peppered with postings for quality managers, quality assurance specialists, quality auditors, quality control technicians, and other roles. Although academic coursework in Quality is in its infancy, opportunities in business … More Why work in Quality?