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
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?
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
6 Novel Mock BIMO Regulatory Inspection Exercises
Don't get caught on your heels. Conducting a mock regulatory inspection in preparation for an FDA, EMA, or other regulatory visit is a key industry inspection readiness activity. Explore six new inspection exercises to help your team prepare for the big day(s).
Learn more
6 Novel Mock BIMO Regulatory Inspection Exercises
Don't get caught on your heels. Conducting a mock regulatory inspection in preparation for an FDA, EMA, or other regulatory visit is a key industry inspection readiness activity. Explore six new inspection exercises to help your team prepare for the big day(s).
Learn more
How Biopharma Leaders Can Ward Off A Perfect Storm: Part 1
Senior biopharma executives can strategically ward off this storm’s potential impact to our industry provided they are fully informed.
Learn more
How Biopharma Leaders Can Ward Off A Perfect Storm: Part 1
Senior biopharma executives can strategically ward off this storm’s potential impact to our industry provided they are fully informed.
Learn more
How Storyboarding Can Bring Clarity To Regulatory Inspection Readiness & Facilitation
Developing storyboards for regulatory inspection readiness and facilitation is a growing trend, yet the tool is shrouded in mystery for many pharma industry professionals. Storyboarding is a powerful approach for boiling down your company’s unique drug development journey into compartmentalized, positive short stories or messages that clarify pivotal points in time or scenarios. They provide a framework for creating clear messaging that can be consistently communicated by the inspection team. This is particularly needed for situations when opportunities for company growth, mitigation of existing gaps, and/or other unique compliance scenarios were self-identified and action was taken to ensure compliance and enable forward movement. They ultimately serve to remove confusion, contradiction, and on-the-spot decision-making when addressing inspection questions about the most difficult, convoluted aspects of your product’s drug development story. All companies have those; you are not alone.
Learn more
How Storyboarding Can Bring Clarity To Regulatory Inspection Readiness & Facilitation
Developing storyboards for regulatory inspection readiness and facilitation is a growing trend, yet the tool is shrouded in mystery for many pharma industry professionals. Storyboarding is a powerful approach for boiling down your company’s unique drug development journey into compartmentalized, positive short stories or messages that clarify pivotal points in time or scenarios. They provide a framework for creating clear messaging that can be consistently communicated by the inspection team. This is particularly needed for situations when opportunities for company growth, mitigation of existing gaps, and/or other unique compliance scenarios were self-identified and action was taken to ensure compliance and enable forward movement. They ultimately serve to remove confusion, contradiction, and on-the-spot decision-making when addressing inspection questions about the most difficult, convoluted aspects of your product’s drug development story. All companies have those; you are not alone.
Learn more