When it comes to GCP audits and inspections, low-hanging fruit says a lot about the tree. Welcome to the mind of an auditor/inspector. I’m going to share the thought process auditors and inspectors commonly use while reviewing job descriptions, CVs, and organizational (org) charts. Ensuring these documents are in tip-top shape is a no-brainer given the high odds they will be requested and reviewed. While establishing excellent processes for SOP and training documentation and maintenance can be complex, updating job descriptions, CVs, and org charts is perhaps one of the simplest processes within the quality system.
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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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.
In clinical research, perhaps our oldest code we live by is the Hippocratic oath. Our industry is more complicated today than ever before, so how can we remain loyal to our shared code while also supporting the innovative solutions and approaches of the modern world?
In clinical research, perhaps our oldest code we live by is the Hippocratic oath. Our industry is more complicated today than ever before, so how can we remain loyal to our shared code while also supporting the innovative solutions and approaches of the modern world?
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.
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.
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.