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101 results of "Life Sciences x" and "Clinical Research x"
Live Webinar

Human Error and Management Systems: Designing Errors Out

If you work in the GMP regulated industry, you not only need to address human error deviations because they are an inconvenience, but you must also do it because the regulation requires it. The CFR - Code of Federal Regulations Title 21 Subpart B_Organization ...

Live Webinar

Excel Spreadsheets; develop and validate for 21 CFR Part 11 compliance

This interactive webinar explains how to configure and validate 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 ho ...

Live Webinar

Corrective and Preventive Action (CAPA)

The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries.   Just as lean principles challenge traditional process concepts and "push ...

  • Basic & Intermediate
  • 90 Mins
  • José Mora
  • Jun 14, 2022
Live Webinar

21 CFR Part 11 Electronic Records/Signatures

The Webinar will focus on the importance of ensuring that the electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.  This includes developing a company philosophy and approach ...

Live Webinar

Best Practices for Preparing for an FDA Computer System Audit

FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules.  This webinar will help you understand the FDA’s current thinking on computer sys ...

Recorded Webinar

GMP Environmental Monitoring for Pharmaceutical Clean Rooms

Environmental Monitoring looks at the end results of the Environmental Control Program – the microbiological and particulate quality of the cleanroom. As the FDA Guideline on Aseptic Processing GMP (2004) states:    “In aseptic processing, one of the most im ...

On-Demand Webinar

Human Error Reduction Techniques for Floor Supervisors

Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar. People make mistakes because they can; our systems allo ...

Recorded Webinar

How to Write SOP's for Human Error Reduction

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. Proced ...

Recorded Webinar

NFPA 70E Arc Flash Training

This webinar training will define what an arc flash is and discuss how to prevent it from occurring. It will offer participants an understanding of the regulatory requirements of the NFPA 70E standard and detail how it applies to your facility. Participants wi ...

Recorded Webinar

Reducing Memory and Attention Failures/Errors: Cognitive Load Assessment

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage and usu ...