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503Bs Adopt Strategies to be FDA Audit-Ready

May 11, 2023

Organizational Readiness for an FDA Audit of a 503B Compounding Pharmacy

Given the FDA’s growing scrutiny over 503B outsourcing facilities (503B) complying with regulatory requirements, many pharmacies are not only preparing for a potential impromptu visit from the FDA, but also building their company culture as an audit-ready organization.

With years of experience as the owner and CEO of Prompt Praxis Laboratories, a 503B testing lab, Lisa McChesney-Harris, PhD, provides strategies for achieving an audit-ready organization in Organizational Readiness for an FDA Audit of a 503B Compounding Pharmacy, a webinar brought to you by bioMérieux. 

In this Webinar, you will learn how to:

  • Develop a better understanding of regulatory expectations and tune into the current regulatory environment
  • Apply tactics for staff to stay current on enforcement activity
  • Employ techniques to effectively instill a regulatory mindset throughout the organization
  • Conduct both internal and external audit programs
  • Build a roadmap to maintaining vigilant management oversight
Watch the On-Demand Webinar

Please note this webinar previously aired on May 4, 2023 with the American Pharmaceutical Review.