<span class="archive__title-prefix>Posts Categorized:</span> Blog

This week marks Quality Week, a weeklong recognition of global quality management professionals.  Each year, the Chartered Quality Institute (CQI) designates a theme for Quality Week. For 2022, the theme is “quality conscience,” i.e., how organizations can adopt practices that ensure robust corporate and quality cultures that drive conscience in ethical decision making. We are […]

How can companies build a strong culture that ensures data integrity? What if there was a way to build a quality culture that merges data integrity and quality culture? And what is the current FDA thinking in this area? On Thursday, Nov. 10, 2022, Ulrich Köllisch, Manager and Subject Matter Expert on Data Integrity, GxP-CC, […]

New and Hybrid Clinical Trial Approaches Under Review Companies and physicians planning and executing clinical trials have been challenged by the special circumstances and constraints brought about by the recent pandemic. The need to conduct the trials has accelerated the creation and adoption of new and hybrid clinical study designs, operational approaches, and data sources. […]

Persistent: (adj): existing for a long or longer than usual time or continuously Non-compliance (noun): failure or refusal to comply with something (such as a rule or regulation): a state of not being in compliance (Both definitions are taken from Merriam-Webster.com.) Put these two words together in the pharma world and the combination creates a […]

Originally published on March 18, 2021, this article examines the post-approval change pilot program in Japan that became effective last year. Japan’s PMDA post-approval change pilot program will become official and codified into law in 2021, bringing Japan into the fold of developed nations including the U.S. and EU that have a streamlined system for […]

What happens when a U.S. pharma company markets a product that is seriously contaminated and causes illness and death? Among other things, FDA investigates. What happens when the company’s senior management fails to make changes promised to the agency to prevent those outcomes from recurring and more illnesses and deaths result? And what happens to […]

Are you fully prepared to audit your suppliers for data integrity compliance? Do you know if your laboratory equipment has the correct data integrity controls? [Related: Click here to access a recording of the webinar, including the full slide presentation.] Owing to the high volume of submitted questions, the presenters of the May 24 webinar, […]

Learn more about the post-approval change management protocol (PACMP) pilot established by Japan’s PMDA in the following article which was originally published on March 18, 2021. Major post-approval changes to pharma manufacturing processes have traditionally taken years to receive regulatory agency approval, independent of whether they improve compliance, implement modern technologies, or drive continual process […]

How well is your organization prepared to pass an FDA audit?  On Oct. 25, 2022, presenters Sam Klooster, VP of Sales, SIMCO Electronics, and Jerry Chapman, Senior GMP Quality Expert, Redica Systems, shared insights and trends from the last five years on the top reasons regulated manufacturers receive 483 observations and warning letters in the […]

Insights from Peter Baker at the 46th International GMP Conference When it comes to data integrity, Peter Baker has seen it all. He is well-known in the industry as a former FDA investigator, and now heads his own firm, Live Oak Quality Assurance. And, as he told the audience in March at the International GMP […]