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16-30 of 76 results
GINETTE COLLAZO
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Jan 01, 2026
01:00 PM
From Training to Human Reliability In Manufacturing
Pharmaceutical manufacturing sites continuously compete, even within the same company to maintain production volumes and avoid closures. To attain a status of a high performing organization manufacturing sites are implem...
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GINETTE COLLAZO
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Jan 01, 2026
01:00 PM
How to Implement an Effective Human Error Investigation Program
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...
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GINETTE COLLAZO
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Jan 01, 2026
01:00 PM
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...
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MARK SMITH
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Dec 26, 2025
03:00 PM
Skill-First Hiring: Why Education and Years of Experience Are Less Important for Many Jobs
Skills-based hiring has been a topic of interest for many businesses and governments for the past few years. But even as interest grows, many hiring managers push back on the idea, worried about the potentially detriment...
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Kelly Thomas
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Jan 01, 2026
01:00 PM
New FDA Draft Guidance Part 11 Compliance
This webinar describe, As part of the Case for Quality program US FDA noted how an excessive focus by the industry on compliance rather than quality may be diverting resources and management attention toward meeting regu...
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JOSE IGNACIO MORA
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Jan 06, 2026
01:00 PM
How to Conduct a Human Factors / Usability Validation?
This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for compliant human factors/usability validation. HF/U validation is very different from device validation. For example, success cri...
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MEREDITH CRABTREE
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Jan 01, 2026
01:00 PM
5 Key Components of Good Manufacturing Practices to obtain cGMP certification
Pharmaceutical and other FDA-regulated industries are tasked with safely manufacturing products for people (or animals) around the world. The FDA has set specific requirements, known as cGMPs) for facilities to meet the...
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JOSE IGNACIO MORA
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Jan 06, 2026
01:00 PM
Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device
Test method validation is an often-confusing requirement for medical devices. A fundamental issue is the role-reversal between the test method and the product or process it is designed to detect. For example, while a def...
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ALAN GOLDEN
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Dec 31, 2025
01:00 PM
CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations
This live interactive presentation will also discuss the regulations associated with the detection, correction, and prevention of human errors in GMP manufacturing and laboratory processes.
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Carolyn Troiano
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Jan 01, 2026
01:00 PM
Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA
FDA has substantial authority to oversee regulated companies and their operations. The primary purpose of FDA is to assure safe and effective products that will protect public health. Violations can have seriously advers...
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Frank Pokrop
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Jan 01, 2026
01:00 PM
Auditing Basics and Fundamentals for Medical Devices and Drugs
Internal audits are not just an important requirement for effective corporate governance – they are intended to show compliance with various domestic and international laws and regulations. Audits are also a fundam...
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CASPER ULDRIKS
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Jan 01, 2026
01:00 PM
EU Medical Devices Regulation: CE Mark Expiration and the EU Refusal of Your Exports
FDA and the EU have tried to harmonize device regulatory requirements for over 25 years. Major differences between the FDA and the EUincludepremarket authorization (CE Mark), complaint investigations, postmarket surveill...
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Susanne Manz
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Jan 01, 2026
01:00 PM
Internal Audit for Medical Device Companies
Internal Audit should be a key part of self-awareness and understanding strengths and weaknesses within your Quality Management System. It should be an essential guide to corrective and preventive action and drive improv...
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SUSAN STRAUSS
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Dec 31, 2025
03:00 PM
Weeding Out The Bad Candidates: Best Practices for Sourcing, Resume Review, and Pre-Screening
Save time and money with these effective prescreening tips and tricks from an active recruiter.
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SUSAN STRAUSS
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Dec 26, 2025
01:00 PM
The Millennial Workforce: How Smart Companies Engage and Tap their Entrepreneurial Energy
“The future belongs to individuals and companies who embrace the entrepreneurial spirit, whether that is inside or outside a company. The fundamental question is what is going to have people get motivated and inspi...
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