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Laboratory Regulations and Guidance Training, Compliance Best Practices and Standards

Laboratory regulations and guidance training through webinars, in-person seminars, standards and best practices. Learn from renowned experts about current and upcoming FDA regulations and guidance for laboratories - USP Chapter <1226>, USP Chapter <1224>, ISO 17025, ICH and USP guidelines, Standard Operating Procedures, Out of Specification (OOS) investigation, CLIA compliance, OIG compliance, etc.

Webinar

/ May

Monday-2025

Performing Effective Management Review of the Quality System

Speaker: David L Chesney
Product ID: 704933
Duration: 90 Min

This webinar will teach you how to conduct an effective management review of the quality system which helps you understand how to plan and focus on right metrics and governed by an efficient process. Participants will also understand FDA policy regarding disclosure of management review information during inspections.

* Per Attendee
$199

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Recorded/CD

FDA Ambitious Regulation of Social Media and Corporate Responsibility

Speaker: Casper Uldriks
Product ID: 703853
Duration: 60 Min

FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.

CD/Recorded
$219

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Recorded/CD

Bacterial Endotoxin Test to Include the Latest on Low Endotoxin Recovery (LER)

Speaker: Barry A Friedman
Product ID: 705433
Duration: 90 Min

The webinar will review the current testing requirements as defined in the new, revised FDA guidance on Endotoxin and Pyrogen testing. It will further help attendees understand the issues surrounding the Low Endotoxin Recovery (LER) and its regulatory outcome.

CD/Recorded
$299

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Recorded/CD

How to Prepare a Standard Operating Procedure (SOP)?

Speaker: Dr. Afsaneh Motamed Khorasani
Product ID: 705131
Duration: 60 Min

This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.

CD/Recorded
$199

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Recorded/CD

Addressing Non-Conformances using Root Cause Analysis (RCA)

Speaker: Michael Brodsky
Product ID: 704861
Duration: 60 Min

In this webinar you will learn how to determine the Root Cause origin of a problem. You will learn a specific set of steps, with associated tools, to find the primary cause of the problem, so that you can prevent occurrences.

CD/Recorded
$229

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