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
Senior biopharma executives can strategically ward off this storm’s potential impact to our industry provided they are fully informed.
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
5 GCP Compliance Mistakes To Avoid With Job Descriptions, CVs, & Org Charts
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.
Learn more
5 GCP Compliance Mistakes To Avoid With Job Descriptions, CVs, & Org Charts
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.
Learn more
3 Essentials For A Fit-For-Purpose Compliance Strategy In Decentralized Pharma
We discuss three essentials for designing a compliance strategy to ensure patient safety and data integrity throughout the decentralized drug development process.
Learn more
3 Essentials For A Fit-For-Purpose Compliance Strategy In Decentralized Pharma
We discuss three essentials for designing a compliance strategy to ensure patient safety and data integrity throughout the decentralized drug development process.
Learn more
Your New 6-Step Approach For CRO Selection In 2022
Unfortunately, whether you've chosen the right clinical research organization (CRO) isn't always obvious until contracts are signed and patients are enrolled. In 2022, basic industry standard steps are being skipped left and right. Here are 6 win-win suggestions to incorporate into your vendor selection strategy/
Learn more
Your New 6-Step Approach For CRO Selection In 2022
Unfortunately, whether you've chosen the right clinical research organization (CRO) isn't always obvious until contracts are signed and patients are enrolled. In 2022, basic industry standard steps are being skipped left and right. Here are 6 win-win suggestions to incorporate into your vendor selection strategy/
Learn more