Standard operating procedures (SOPs) have become the documentation backbone of our industry and, yes, at times, a major pain in the neck. Those of us who were around during the 80s may be able to recall fuzzy memories of SOPs being a thing . Fast forward to 2019, past the birth of ICH, the evolution of outsourcing, the techno explosion and the FDA’s 21 CFR Part 11, the EU obsession with quality systems, and the more recent rise of the big vendor. Today, we’re buried in mountains of SOPs.
Penelope Przekop is a is a biopharmaceutical quality assurance and corporate compliance executive consultant with global R&D and commercial PV expertise. During the early 2000s, she developed and oversaw the first global PV quality and compliance departments established for Wyeth as well as Johson & Johnson. Her work includes qualification and oversight of numerous PV vendors covering all aspects of clinical safety and post-marketed PV. Penelope has facilitated numerous PV regulatory inspections. She frequently leads and conducts PV mock inspections and provides in-depth PV training.
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Don't get caught on your heels. Conducting a mock regulatory inspection in preparation for an FDA, EMA, or other regulatory visit is a key industry inspection readiness activity. Explore six new inspection exercises to help your team prepare for the big day(s).
Don't get caught on your heels. Conducting a mock regulatory inspection in preparation for an FDA, EMA, or other regulatory visit is a key industry inspection readiness activity. Explore six new inspection exercises to help your team prepare for the big day(s).
In addition to my career as a pharma industry consultant, I’m a writer. While I don’t claim to be the next Ernest Hemingway, I do consider myself a decent writer. I’ve put in the 10,000 hours of writing Malcolm Gladwell told us it takes to be an expert in his 2008 book, Outliers: The Story of Success . I’ve always had a passion for writing. At 24, I made a serious commitment to become a real “writer.” I dedicated bits and pieces of my free time over the next five years to writing my first novel. During that time, I wasn’t focused on how improving my writing skills might impact my pharma industry career, which was well underway. Now, I know firsthand that all those high school and college English, writing, and literature teachers and professors were right when they told us that excellent writing skills can take us far in any career.
In addition to my career as a pharma industry consultant, I’m a writer. While I don’t claim to be the next Ernest Hemingway, I do consider myself a decent writer. I’ve put in the 10,000 hours of writing Malcolm Gladwell told us it takes to be an expert in his 2008 book, Outliers: The Story of Success . I’ve always had a passion for writing. At 24, I made a serious commitment to become a real “writer.” I dedicated bits and pieces of my free time over the next five years to writing my first novel. During that time, I wasn’t focused on how improving my writing skills might impact my pharma industry career, which was well underway. Now, I know firsthand that all those high school and college English, writing, and literature teachers and professors were right when they told us that excellent writing skills can take us far in any career.
Small to midsize pharmaceutical or biotech companies (small pharma) are enjoying the best of times. Many have exciting products with fantastic preclinical and/or clinical results, great platforms for long-term company growth and licensing possibilities, outstanding medical and technical expertise, and support from intellectual/academic experts. However, from a quality systems perspective, it could be the worst of times. Many have weak quality systems, are not following global regulatory authority regulations and/or guidance, or lack the level of documentation required to reconstruct every aspect of clinical trials.
Small to midsize pharmaceutical or biotech companies (small pharma) are enjoying the best of times. Many have exciting products with fantastic preclinical and/or clinical results, great platforms for long-term company growth and licensing possibilities, outstanding medical and technical expertise, and support from intellectual/academic experts. However, from a quality systems perspective, it could be the worst of times. Many have weak quality systems, are not following global regulatory authority regulations and/or guidance, or lack the level of documentation required to reconstruct every aspect of clinical trials.
The clinical quality management systems approach developed 20 years ago is not sustainable in the today's industry because we've seen dramatic industry changes in outsourcing, remote monitoring, the use of electronic systems in clinical research, and more. But how do we update our approach for 2022 pharma? This article examines 4 imperatives, including how to accomplish them.
The clinical quality management systems approach developed 20 years ago is not sustainable in the today's industry because we've seen dramatic industry changes in outsourcing, remote monitoring, the use of electronic systems in clinical research, and more. But how do we update our approach for 2022 pharma? This article examines 4 imperatives, including how to accomplish them.