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511 results of "Life Sciences x"
Live Webinar

Guidance for Lubricant Use in Food Applications

Over application or incorrect usage of lubricants can lead to insanitary conditions or contamination. Often condensate plays a big part in refrigerated foods and mixed with improper use of lubricants can spell potential problems in the environment. Proper appl ...

  • Basic & Intermediate
  • 60 Mins
  • Gina Reo
  • May 29, 2020
Live Webinar

Human Factors/ Usability Studies following ISO62366 and the New FDA Guidance

Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the ef ...

Live Webinar

Secrets to Writing Effective SOPs

Almost every paragraph of the Quality System Regulation says that manufacturers shall “establish” procedures.This webinar will help you to write complete, clear, unambiguous, and flexible SOPs that accomplish that objective.You will learn techniques for creati ...

Live Webinar

US FDA and EU MDR Basic Medical Device Documentation Requirements

This webinar will examine the requirements for the U.S. FDA's DHF -including its derivitive documents, the DMR and DHR. It will consider the European Union's new MDR Technical Documentation requirements. It will evaluate the documents' differing purposes / goa ...

Live Webinar

Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

This webinar will provide the best industry practices to follow when auditing a vendor of a computer system that is regulated by FDA. We will discuss the best approach for assessing a vendor’s organization, capability, physical/logical security practices, requ ...

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