Search Trainings

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

FDA’s Recent Clarification on Guidance for Managing Data Integrity for Regulated Computer Systems

The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines. This includes development of a company philosophy and approach, and incorporating it into an overall computer system v ...

Live Webinar

Controlling Human Error in the Manufacturing Floor

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

Live Webinar

Understanding Initial IND Submission- The first 30 days

This webinar will shed light on the entire process that takes place from the time the sponsor submits the initial IND to the FDA for initial 30-days. Alongside this presentation would detail the various grounds on which the FDA may consider placing a clinical ...

Live Webinar

Proper CAPA Management

In order to solve problems, every organization must know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner. An effective CAPA process requires training internal investigators, who can a ...

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

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 ...

Recorded Webinar

FDA's Regulation of Over-the-Counter (OTC) Drugs Monographs and NDAs for Safety and Efficacy Goals

The three ways that the FDA regulates OTC (Over-the-Counter) drugs: Monographs, Rx to OTC switches and NDA/ANDA submissions, will be discussed in detail. Labeling and advertising of OTC drugs will be covered. Other requirements, including Registration, Drug Li ...

Recorded Webinar

Reduce Compliance and Recordkeeping Burdens

This 90 minute webinar will cover strategies to improve the efficiency of your Quality Management System (QMS) for medical device companies.An effective yet efficient quality system can be a competitive advantage for companies by leading to improved quality an ...

On-Demand Webinar

Proper Execution of Annual Product Reviews

This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements as per US and Europe. Annual Product Quality Review ...