How To Improve FDA Inspection Readiness & Outcomes By Mining Publicly Available Data

October 14, 2020
By Penelope Przekop
Quality
Inspection Readiness
Quality Systems
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?

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.

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