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Quality Assurance and Quality Controls Training - Live Webinars, Recordings & CDs

Whether you are a quality assurance or a quality control professional, you know how the rapid transformations in regulatory requirements and technology are changing the nature of your work. We understand this challenge and have put together quality assurance and quality control courses to help you make your role robust-proof. Browse for the many courses, standards, and tools of specific interest to you.

Recorded/CD

Stability Program for Pharmaceuticals and Biologics

Speaker: Nanda Subbarao
Product ID: 705455
Duration:

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.

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Recorded/CD

Managing your GMP Quality Control (QC) Labs in Compliance with FDA Regulations

Speaker: Kim Huynh-Ba
Product ID: 705081
Duration:

This webinar will discuss the common deficiencies in relation to compliance and validation issues that typically found with pharmaceutical Quality Control labs.

CD/Recorded
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Recorded/CD

Studies to Support Temperature Excursions and Shipping of Pharmaceutical Products

Speaker: Kim Huynh-Ba
Product ID: 704770
Duration:

Upon completion of this training program, attendees will learn key factors that would affect the shipping and distribution of drug products. One must understand the product stability profile, typical environmental conditions for storage and anticipating environmental extremes for distribution. These data will be necessary to design shipping conditions in order to maintain quality of the drug product through expiry.

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Recorded/CD

Establish an Effective Change Management Process for Stability Studies

Speaker: Kim Huynh-Ba
Product ID: 704085
Duration:

Upon completion of this training program, attendees will learn key elements of a change management process, identify key indicators of change and learn the regulatory requirements for change control. This session will also discuss different observations due to the lack of effective change control program.

CD/Recorded
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Recorded/CD

Annual GLP Refresher Course - 4 Hour Virtual Training

Speaker: Nanda Subbarao
Product ID: 704893
Duration:

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.

CD/Recorded
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Recorded/CD

Current Regulatory Requirements for Aseptically Produced Products

Speaker: Kenneth Christie
Product ID: 704791
Duration:

The manufacture of sterile products and the risk they represent to the public is always on the fore front of inspectors during regulatory audits. As a result, the manufacture of sterile products require a high degree of control of incoming materials, the manufacturing process and the control of personnel to name a few. A weakness in any of these items can jeopardize the sterility assurance of the final product. This training program will highlight and summarize the following main components relating to current validation requirements for sterile products and include the following; review of the current regulations and guidance documents, the typical expectations when aseptic processing is involved, the expectations for protocols used to document the qualification of associated equipment, utilities and processes, and recently cited regulatory deficiencies.

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