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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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.
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.
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.
Small to midsize pharmaceutical or biotech companies (small pharma) are enjoying the best of times. Many have exciting products with fantastic preclinical and/or clinical results, great platforms for long-term company growth and licensing possibilities, outstanding medical and technical expertise, and support from intellectual/academic experts. However, from a quality systems perspective, it could be the worst of times. Many have weak quality systems, are not following global regulatory authority regulations and/or guidance, or lack the level of documentation required to reconstruct every aspect of clinical trials.
Small to midsize pharmaceutical or biotech companies (small pharma) are enjoying the best of times. Many have exciting products with fantastic preclinical and/or clinical results, great platforms for long-term company growth and licensing possibilities, outstanding medical and technical expertise, and support from intellectual/academic experts. However, from a quality systems perspective, it could be the worst of times. Many have weak quality systems, are not following global regulatory authority regulations and/or guidance, or lack the level of documentation required to reconstruct every aspect of clinical trials.