FDA's New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices Webinar training seminars presented by Online Compliance Panel register now on FindaSeminar.com

findaseminar logo balls FindaSeminar.com
event search registration and marketing services since 2002
Advanced Search
 
 

FDA's New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices Webinar  

 Email information about this seminar FDA's New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices Webinar by Online Compliance Panel to yourself your manager or associates Email this event... View and register for other training seminars like FDA's New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices Webinar by Online Compliance Panel on FindaSeminar.com Find similar training.. Find and register for other training seminars by Online Compliance Panel on FindaSeminar.com Other seminars from Online Compliance Panel

By:

Online Compliance Panel   

For:

Cost:   

see Registration info for seminar cost, group discount etc.

Seminar Summary:

Learn current testing requirements, what happened to the old LAL Guidance for industry document, documents supporting this new Guidance, more. (see full course description)

 

 Seminar / Training class dates & locations

 
 SORT RESULTS BY:

 DATE

LOCATION

SELECTED VENUE DETAILS

Facility Name: 
Address:





Registration Information:

Event cost:  $
USD

class times and cancellation policy

 
 




 From 
 To 
 Click to register by Register by fax for FDA's New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices Webinar training seminar Register by mail for FDA's New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices Webinar training seminar Register by phone to attend FDA's New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices Webinar training seminar

Print payment approval request form FDA's New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices Webinar training seminar

Pre-Registration questions? Find answers in our registration FAQ or Request information about upcoming training seminars workshops and conferences in   and other cities listed on FindaSeminar.com Submit a support request

 
 

 

share this page 

print the agenda print agenda for the FDA's New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices Webinar seminar

 

 

Training Course Syllabus:


FDA's New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices Webinar



Time: 10:00 AM PDT | 01:00 PM EDT

Duration: 90 Minutes

Instructor: Angela K. Dunston


Description:

This session will provide the participants with best practices regarding policies and procedures for mitigating workplace violence and hostility. Attention will be devoted to current trends (U.S), civil/legal expectations and necessary policies. Further, the impact that a hostile environment has on productivity and the organizational bottom line will be discussed along with easy remedies to mitigate this impact.


Why Should you Attend

The current thinking of the FDA regarding the use of the Limulus Amoebycyte Lysate (LAL) test for endotoxins in lieu of the rabbit pyrogens test has changed. As a result, the last guidance document, Guideline on Validation of the Limulus Amedocyte Lysate (LAL) Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices, which was published in 1987, has been withdrawn by the agency.


Objectives of the Presentation:


  • Provide a review of the current testing requirements

  • Understanding what happened to the old 87/91 LAL Guidance for industry document

  • Learn what has replaced it and why

  • Learn common issues, misunderstandings and misinterpretations

  • Determine who comprised the agency guidance team involved with in this new proposed Guidance

  • Learn the documents supporting this new Guidance

  • Learn about sampling, storage, handling and pooling

  • How does one transition from one bacterial endotoxin test to another—understand the RPT (Rabbit Pyrogen Test)

  • Learn about the Monocyte Activation Test (MAT). Determine when the Rabbit Pyrogen Test is appropriate to use in lieu of the LAL

  • Understand the FDA´s expectation for screening of therapeutic products.

Seminar Summary:

Learn current testing requirements, what happened to the old LAL Guidance for industry document, documents supporting this new Guidance, more. (see full course description)

print this agenda print agenda for the FDA's New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices Webinar training seminar

 view dates and locations for this seminar

 

 

 

Custom Search