WEBINARS

 

Microbiology Laboratory Regulatory Compliance Training - Live Webinars, Recordings & CDs

Why I should test raw materials for microbial presence and what is the microbiological and business risk if I choose not to?

webinar-speaker   Henry Urbach

webinar-time   90 Min

Product Id: 703058

This webinar on biopharmaceutical raw material testing will discuss how to implement processes for the control of microbial contamination, establish microbial limits and mitigate the risk of contamination.

Recording Available

* Per Attendee $199

 

Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing

webinar-speaker   Henry Urbach

webinar-time   60 Min

Product Id: 702634

This 60-minute webinar will show how you can design a robust microbiological audit program for pharmaceutical and biopharmaceutical product manufacturing, that effectively assesses your facility and that of your supplier to ensure your facilities and products are free from microbial contamination.

Recording Available

* Per Attendee $229

 

Emerging Issues in Food Safety - Locally, Nationally and Globally

webinar-speaker   Michael Brodsky

webinar-time   60 Min

Product Id: 704518

This training program will focus on understanding and accepting our respective responsibilities to help ensure that our food supply is safe by pursuing a food safety culture locally, nationally and globally.

Recording Available

 

Process Robustness: The New FDA Paradigm

webinar-speaker   Angela Dunston

webinar-time   90 Min

Product Id: 703990

In this training program, attendees will learn how process robustness tools and metrics can be utilized to enhance process understanding and control. The new FDA paradigm is shifting to the expectation that organizations certified by other standards such as ISO and EFfCI demonstrate process robustness. It is the obligation of the primary pharmaceutical provider to ensure process robustness throughout the supply chain.

Recording Available

* Per Attendee $229

 

Ensuring the Microbiological Integrity of Pharmaceutical and Biopharmaceutical Facilities

webinar-speaker   Frank Settineri

webinar-time   90 Min

Product Id: 701145

This Microbiology training/webinar will provide a new approach in ensuring the Microbiological Integrity of Pharmaceutical and Biopharmaceutical Facilities.

Recording Available

* Per Attendee $199

 

The Regulatory Expectations for Environmental Monitoring Programs

webinar-speaker   Kenneth Christie

webinar-time  

Product Id: 703648

Understand the importance of an effective environmental monitoring (EM) program and its place in your organization. This course will provide insights on regulatory requirements governing EM programs, contamination control practices, and common deficiencies cited by regulatory auditors when auditing EM programs.

Recording Available

 

Avoiding FDA observations: Do's and Don'ts during Laboratory Inspections

webinar-speaker   Kim Huynh-Ba

webinar-time  

Product Id: 703278

This training will provide the attendees best practices for handling FDA inspections to avoid form 483 and Warning Letters.

Recording Available

 

Stability Program for Pharmaceuticals and Biologics

webinar-speaker   Nanda Subbarao

webinar-time  

Product Id: 705455

This webinar will provide an overview of the stability studies required for pharmaceuticals and biologics. It will also provide a summary of recent developments in the industry and regulatory requirements in this field.

Recording Available

 

Annual GLP Refresher Course - 4 Hour Virtual Training

webinar-speaker   Nanda Subbarao

webinar-time  

Product Id: 704893

An Annual GLP training is a requirement for all personnel involved in Good Laboratory Practices (GLP) studies. The webinar course serves both as an initial training for new employees, new to GLP concepts will serving as a refresher course for experienced senior employees. The webinar provides an overview of the GLP to remind the attendees of the regulatory requirements for organizations in which bioanalytical testing is conducted.

Recording Available

 

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