On Jan. 31, 2024, the FDA, in collaboration with the Duke-Margolis Institute for Health Policy, convened a public workshop, Building Quality into the Design and Conduct of Clinical Studies: Integrating Quality by Design (QbD) and Risk-Based Monitoring (RBM) Approaches.
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.
Read more from PDC’s teams of experts.
Find out the reasons why our industry, your company, and employees should value the unique skillset of the quality and compliance professionals more than ever in decentralized pharma.
Find out the reasons why our industry, your company, and employees should value the unique skillset of the quality and compliance professionals more than ever in decentralized pharma.
Many sponsors and CROs conduct mock inspections to determine organizational inspection and audit readiness. Investing in a regulatory mock inspection demonstrates a serious commitment to patient safety, data integrity, and regulatory compliance. It is also a proactive strategy to safeguard financial health, particularly for startups and companies with sparse pipelines.
Many sponsors and CROs conduct mock inspections to determine organizational inspection and audit readiness. Investing in a regulatory mock inspection demonstrates a serious commitment to patient safety, data integrity, and regulatory compliance. It is also a proactive strategy to safeguard financial health, particularly for startups and companies with sparse pipelines.
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.
Developing storyboards for regulatory inspection readiness and facilitation is a growing trend, yet the tool is shrouded in mystery for many pharma industry professionals. Storyboarding is a powerful approach for boiling down your company’s unique drug development journey into compartmentalized, positive short stories or messages that clarify pivotal points in time or scenarios. They provide a framework for creating clear messaging that can be consistently communicated by the inspection team. This is particularly needed for situations when opportunities for company growth, mitigation of existing gaps, and/or other unique compliance scenarios were self-identified and action was taken to ensure compliance and enable forward movement. They ultimately serve to remove confusion, contradiction, and on-the-spot decision-making when addressing inspection questions about the most difficult, convoluted aspects of your product’s drug development story. All companies have those; you are not alone.
Developing storyboards for regulatory inspection readiness and facilitation is a growing trend, yet the tool is shrouded in mystery for many pharma industry professionals. Storyboarding is a powerful approach for boiling down your company’s unique drug development journey into compartmentalized, positive short stories or messages that clarify pivotal points in time or scenarios. They provide a framework for creating clear messaging that can be consistently communicated by the inspection team. This is particularly needed for situations when opportunities for company growth, mitigation of existing gaps, and/or other unique compliance scenarios were self-identified and action was taken to ensure compliance and enable forward movement. They ultimately serve to remove confusion, contradiction, and on-the-spot decision-making when addressing inspection questions about the most difficult, convoluted aspects of your product’s drug development story. All companies have those; you are not alone.