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

 

Quality Control for Microbiological Media and Reagents

webinar-speaker   Michael Brodsky

webinar-time   60 Min

Product Id: 703233

The webinar will discuss best QC practices and procedures for verifying the suitability and performance characteristics of microbiological media and reagents.

Recording Available

* Per Attendee $229

 

Clinical Importance of Objectionable Organisms

webinar-speaker   Ziva Abraham

webinar-time   60 Min

Product Id: 703072

This webinar on objectionable microorganisms will show how to identify and prevent objectionable microorganisms that are beyond the ones outlined in USP <1111>. Attendees will learn the clinical implications due to presence of objectionable microorganisms.

Recording Available

 

Auditing the QC Microbiology Laboratory for FDA Compliance

webinar-speaker   Chitra Edwin

webinar-time   75 Min

Product Id: 701364

This microbiology laboratory training will provide a comprehensive overview of the infrastructure of a compliant microbiology testing laboratory, preparation for an inspection, potential areas for nonconformance, test failures and resolution of audit findings.

Recording Available

* Per Attendee $349

 

Microbiological Sampling of Foods

webinar-speaker   Jim Dickson

webinar-time   60 Min

Product Id: 702659

This webinar on microbiological sampling for foods will address fundamental approaches to sampling, from raw materials to finished products. Topics will include sampling plans, sample collection methods and chain of custody issues. A primary focus will be on interpretation of results, based on the limitations of sampling plans and microbiological methods.

Recording Available

* Per Attendee $229

 

Personnel Practices and Microbial Control in Pharmaceutical, Biotech, and Medical Device Manufacturing

webinar-speaker   Jim Polarine

webinar-time   90 Min

Product Id: 702446

This 90-minute webinar on personnel practices and microbial control in Pharmaceutical, Biotech, and Medical Device manufacturing will cover effective ways to train personnel on gowning and personnel practices in cleanroom operations to limit contamination. This webinar will also address controlling microorganisms on process equipment and product contact surfaces.

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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