Why I should test raw materials for microbial presence and what is the microbiological and business risk if I choose not to?
Henry Urbach
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.
Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing
Henry Urbach
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.
Emerging Issues in Food Safety - Locally, Nationally and Globally
Michael Brodsky
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.
Process Robustness: The New FDA Paradigm
Angela Dunston
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.
Quality Control for Microbiological Media and Reagents
Michael Brodsky
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.
Clinical Importance of Objectionable Organisms
Ziva Abraham
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.
Auditing the QC Microbiology Laboratory for FDA Compliance
Chitra Edwin
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.
Microbiological Sampling of Foods
Jim Dickson
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.
Personnel Practices and Microbial Control in Pharmaceutical, Biotech, and Medical Device Manufacturing
Jim Polarine
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.
Ensuring the Microbiological Integrity of Pharmaceutical and Biopharmaceutical Facilities
Frank Settineri
90 Min
Product Id: 701145
This Microbiology training/webinar will provide a new approach in ensuring the Microbiological Integrity of Pharmaceutical and Biopharmaceutical Facilities.
The Regulatory Expectations for Environmental Monitoring Programs
Kenneth Christie
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.
Avoiding FDA observations: Do's and Don'ts during Laboratory Inspections
Kim Huynh-Ba
Product Id: 703278
This training will provide the attendees best practices for handling FDA inspections to avoid form 483 and Warning Letters.
Stability Program for Pharmaceuticals and Biologics
Nanda Subbarao
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.
Annual GLP Refresher Course - 4 Hour Virtual Training
Nanda Subbarao
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.