PDC Pharma Strategy is the #1 pharmaceutical consulting firm in 2024
Qualio recognizes PDC Pharma Strategy as the top 1 pharmaceutical consulting firm one should consider for 2024.
Learn more
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.
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.
PDC Pharma Strategy is the #1 pharmaceutical consulting firm in 2024
Qualio recognizes PDC Pharma Strategy as the top 1 pharmaceutical consulting firm one should consider for 2024.
Learn more
3 Tips To Get The Best Bang For Your Mock Inspection Buck
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.
Learn more
3 Tips To Get The Best Bang For Your Mock Inspection Buck
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.
Learn more
How Biopharma Leaders Can Ward Off A Perfect Storm: Part 2
Amid all this financial and operational strategizing, a huge puzzle piece is often left to the side: compliance.
Learn more
How Biopharma Leaders Can Ward Off A Perfect Storm: Part 2
Amid all this financial and operational strategizing, a huge puzzle piece is often left to the side: compliance.
Learn more
How To Improve FDA Inspection Readiness & Outcomes By Mining Publicly Available Data
Now that we have years of real-world regulatory outcomes data available, why are we ignoring their power to serve as a corrective lens for our interpretations of the law?
Learn more
How To Improve FDA Inspection Readiness & Outcomes By Mining Publicly Available Data
Now that we have years of real-world regulatory outcomes data available, why are we ignoring their power to serve as a corrective lens for our interpretations of the law?
Learn more