Amid all this financial and operational strategizing, a huge puzzle piece is often left to the side: compliance.
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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Find out the reasons why our industry, your company, and employees should value the unique skillset of the quality and compliance professionals more than ever in decentralized pharma.
Find out the reasons why our industry, your company, and employees should value the unique skillset of the quality and compliance professionals more than ever in decentralized pharma.
The ultimate purpose of sponsor oversight is to act when required. Audits, meetings, and documentation are not always enough. Too many sponsors seem to be forgetting that they are the customer; one that’s paying a heavy price for services that can ultimately make or break them. Reset the industry balance with these 3 best practices.
The ultimate purpose of sponsor oversight is to act when required. Audits, meetings, and documentation are not always enough. Too many sponsors seem to be forgetting that they are the customer; one that’s paying a heavy price for services that can ultimately make or break them. Reset the industry balance with these 3 best practices.
Standard operating procedures (SOPs) have become the documentation backbone of our industry and, yes, at times, a major pain in the neck. Those of us who were around during the 80s may be able to recall fuzzy memories of SOPs being a thing . Fast forward to 2019, past the birth of ICH, the evolution of outsourcing, the techno explosion and the FDA’s 21 CFR Part 11, the EU obsession with quality systems, and the more recent rise of the big vendor. Today, we’re buried in mountains of SOPs.
Standard operating procedures (SOPs) have become the documentation backbone of our industry and, yes, at times, a major pain in the neck. Those of us who were around during the 80s may be able to recall fuzzy memories of SOPs being a thing . Fast forward to 2019, past the birth of ICH, the evolution of outsourcing, the techno explosion and the FDA’s 21 CFR Part 11, the EU obsession with quality systems, and the more recent rise of the big vendor. Today, we’re buried in mountains of SOPs.
Global biopharma regulations and guidelines require that individuals involved in conducting clinical trials be qualified by a combination of education, training, and experience. The components are straightforward to implement regarding internal employees, but not so clear when it comes to part-time consultants contracted to intermittently execute specific good clinical practice (GCP) tasks. Discover three trips for training independent consultants.
Global biopharma regulations and guidelines require that individuals involved in conducting clinical trials be qualified by a combination of education, training, and experience. The components are straightforward to implement regarding internal employees, but not so clear when it comes to part-time consultants contracted to intermittently execute specific good clinical practice (GCP) tasks. Discover three trips for training independent consultants.