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

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

Organizational Readiness for an FDA Audit of a 503B Compounding Pharmacy
May 4th, 2023 • 11 a.m. PT, 2 p.m. ET

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Overview

In this webinar you’ll learn how to apply strategies for achieving an audit-ready organization, develop a better understanding of regulatory expectations and tune into the current regulatory environment. You will learn how to stay current on enforcement activity and how to effectively instill a regulatory mindset throughout the organization, so that your organization values both Internal and External audit programs. Finally, you will learn how to maintain vigilant management oversight.

Who should attend:

Lab Management – 503B Compounding Pharmacy
Quality Control/Assurance/Validation: Managers and Directors – 503B Compounding Pharmacy
Procurement – 503B Compounding Pharmacy
Management: C-Suite, Lab Owner – 503B Compounding Pharmacy
Regulatory Affairs professionals and Regulatory agencies – USP, FDA on 503B Compounding Pharmacy

Lisa McChesney-Harris, PhD

CEO, CSO & Founder
Prompt Praxis Labs

Mike Auerbach

(Moderator)
Editor-in-Chief,
American Pharmaceutical Review

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Prompt Praxis Laboratories, LLC, founded in 2011, is a women-owned fully-integrated analytical and microbiological testing lab powered with the current information technology to facilitate rapid drug development.

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FDA & DEA Registrations

FDA Establishment Identifier:
3009381492

GDUFA Self-Identified

Illinois DEA:
(Analytical Laboratory, Schedules II-V)
097.001930

Federal DEA:
(Analytical Laboratory, Schedules II-V)
RM0458097

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50 Lakeview Parkway, Suite 123
Vernon Hills, IL 60061-1590

150 N Fairway Drive, Suites 148-154
Vernon Hills, IL 60061-1860

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