Senior biopharma executives can strategically ward off this storm’s potential impact to our industry provided they are fully informed.
SOP Remediation: When Reinventing The Wheel Is The Best Approach
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.
About the Author

Penelope Przekop, CEO
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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Senior biopharma executives can strategically ward off this storm’s potential impact to our industry provided they are fully informed.
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Amid all this financial and operational strategizing, a huge puzzle piece is often left to the side: compliance.
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