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517 results of "Life Sciences x"
Live Webinar

How to Properly Investigate OOS Results

This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and ...

Live Webinar

Developing an Environmental Monitoring Program Satisfying FDA’s Listeria Monocytogenes Guidance

FSMA (Food Safety Modernization Act) requires organizations to assess risks, enact Preventative Controls to mitigate these risks and minimize Food Safety Hazards for consumers. With few exceptions, this generally requires rigorous programs such as an Environme ...

  • Basic & Intermediate
  • 60 Mins
  • Gina Reo
  • Jun 09, 2020
Live Webinar

CMO Supplier Quality Agreements: How to Comply with new FDA and EU Guidelines for Contract Drug Manufacturers

In 2010, the global CMO market was estimated at $26 billion dollars. Year on year growth has been 10.7% since 2008. The increasing use of outsourcing in the pharmaceutical industry along with recent well-publicized quality issues with CMOs, make it a necessity ...

Live Webinar

Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance

This interactive webinar explains how to configure and validate a GxP compliant spreadsheet applications to avoid FDA 483s. Follow the step-by-step instructions as we configure Excel for audit trails, security features, and data entry verification. Understand ...

Live Webinar

The Use Of Statistical Process Control (SPC) Using Control Charts To Maintain Compliance In The Laboratory

Statistics can be used to monitor critical variable in the running of a procedure and in the performance of the instrumentation that performs it. By applying Nelson’s rules this data can be evaluated as performing as expected or performing in ways that are sta ...

  • Basic & Intermediate
  • 60 Mins
  • John Fetzer
  • Jun 16, 2020
Live Webinar

Sponsor's responsibilities for an Active Investigational New Drug (IND)

This webinar will shed light on all the sponsor’s responsibilities for an Active Investigational New Drug application (IND). Alongside this presentation would detail each of the sponsor’s activity in greater detail including timelines to implement the same. Wh ...

Live Webinar

Understanding Human Error in Manufacturing: Methodology for Investigations

As technology advances, human error in manufacturing becomes more and more visible every day. Human error is responsible for more than 80 percent of process deviations in manufacturing environments. Sadly, little is known about the nature of these events mainl ...

Live Webinar

Ten Keys for Maximizing the Benefits of your SPC Program

Statistical Process Control charts have been called the Voice of the Process. Progressive manufacturers utilize control charts to “listen” to their processes so that potentially harmful changes will be quickly detected and rectified.  However, not all SPC pro ...

Live Webinar

Fundamentals of Fraud

Fraud is a constant in our lives and must be recognized and eliminated wherever possible.In business, non profit, and business environments it is the responsibility of everyone within an organization to be able to identify fraud. If we do not perform due dilig ...

Live Webinar

Analytical Method Validation and Transfer

This course provides guidance on how to perform QC analytical test method validations and transfers. One of the most critical factors in developing and marketing pharmaceutical drug substances and drug products is ensuring that the analytical methods used for ...