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?
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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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.
Qualio recognizes PDC Pharma Strategy as the top 1 pharmaceutical consulting firm one should consider for 2024.
Qualio recognizes PDC Pharma Strategy as the top 1 pharmaceutical consulting firm one should consider for 2024.
There is a growing industry focus on standard operating procedure (SOP) remediation. Although outsourcing, mergers, and acquisitions have been in play for the last 20 years, these activities seem to be skyrocketing, which is creating quite a few scenarios that drive the need for SOP remediation.
There is a growing industry focus on standard operating procedure (SOP) remediation. Although outsourcing, mergers, and acquisitions have been in play for the last 20 years, these activities seem to be skyrocketing, which is creating quite a few scenarios that drive the need for SOP remediation.
Include quality and customer satisfaction strategies and goals in all levels of the company. Relay and demonstrate the expectations, and then hold employees accountable. Everyone should know that the company’s commitment to quality is real; it’s not just pretty words on paper.
Include quality and customer satisfaction strategies and goals in all levels of the company. Relay and demonstrate the expectations, and then hold employees accountable. Everyone should know that the company’s commitment to quality is real; it’s not just pretty words on paper.