How Biopharma Leaders Can Ward Off A Perfect Storm: Part 1
Senior biopharma executives can strategically ward off this storm’s potential impact to our industry provided they are fully informed.
Learn more
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.
About the Author
Penelope Przekop, CEO
MSQA, RQAP-GCP
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.
Related Content
Read more from PDC’s teams of experts.
How Biopharma Leaders Can Ward Off A Perfect Storm: Part 1
Senior biopharma executives can strategically ward off this storm’s potential impact to our industry provided they are fully informed.
Learn more
Penelope Przekop: Bringing the science of quality management to the pharma sector
In an interview with PerceptivX, Penelope shares exclusive insight on her background and why it’s high time to revolutionize regulatory compliance strategy in the pharmaceutical industry. She also spoke about the importance of leading authentically, overcoming fears to achieve goals and things she’d like most to change about the world.
Learn more
Penelope Przekop: Bringing the science of quality management to the pharma sector
In an interview with PerceptivX, Penelope shares exclusive insight on her background and why it’s high time to revolutionize regulatory compliance strategy in the pharmaceutical industry. She also spoke about the importance of leading authentically, overcoming fears to achieve goals and things she’d like most to change about the world.
Learn more
3 Surefire Approaches To SOP Harmonization
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.
Learn more
3 Surefire Approaches To SOP Harmonization
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.
Learn more
The Growing Value of Quality & Compliance Professionals 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.
Learn more
The Growing Value of Quality & Compliance Professionals 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.
Learn more