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

How to Write Sop'S that Avoid Human Error

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 ...

Live Webinar

Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs), as well as, how to utilize those metrics to drive Quality Culture. Metrics for numerous departmental functional areas will be discussed; incl ...

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

Corrective and Preventive Action - Your Most Important Process

While ISO 9001:2015 assigns corrective and preventive action to clauses 8.7 and 6.1 respectively, the same process can handle both activities and support other ISO requirements such as the organizational knowledge data base. It can also be extended to exploit ...

Live Webinar

Non-conforming Material and Failure Investigations

Non-conforming material happens.  And medical device companies must deal it. This 90-minute webinar will help you to make sense of confusing regulations and effectively deal with non-conforming material.You’ll learn where non-conforming material can occur and ...

Live Webinar

Effective Batch Record Review

In this webinar attendees will learn the fundamentals for reviewing batch records in a pharmaceuticals, biologics and medical devices environment. You will hear about the proper training that must be demonstrated before one is considered a suitable reviewer of ...

Live Webinar

Avoiding Death by CAPA – What you need to know

CAPA is the foundation of an effective Quality Management System.  Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.  Not only do they fail to achieve necessary improvements, they waste precious time and resources. ...

Live Webinar

Validation Master Plan - Written and Unwritten Requirements

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Validation Master Plan, evaluating its elements ag ...

Live Webinar

21 CFR Part 11 (Electronic Records and Signatures) Compliance for Computer Systems Regulated by FDA

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

Live Webinar

Mobile Medical Apps(is it a FDA regulated device) and Cyber Security

This webinar will explain how to determine if your app is a medical device and if it will be subject to FDA requirements.The FDA approval process for a new app will be explained including FDA requirements for software validation which are more extensive than j ...