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229 results of "Life Sciences x" and "FDA Compliance x"
Live Webinar

Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

Establishing appropriate Quality Assurance metrics is important for several reasons.  Metrics not only measure the health of your quality system, they have the ability to change behavior, drive quality culture and improve both individual and company performanc ...

Live Webinar

Medical Device Hazard analysis following ISO 14971

The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects a post production risk management program be implemented. FDA recommends using ISO 14971 as a guide and has accepted it as a re ...

Live Webinar

Nacha Rule Update

During this webinar, we will review recent changes to the ACH rules and also discuss upcoming changes that might impact your organization or specifically, your role. Course Objectives:  The foundation of ACH and Nacha Understand the rules created by Nacha ...

Live Webinar

Analytical Method Validation and Transfer

This course provides guidance on how to perform QC analytical test method validations and transfers. One of the most critical factors in developing and marketing pharmaceutical drug substances and drug products is ensuring that the analytical methods used for ...

Live Webinar

Risk Based Design Control Requirements and Industry Best Practices for Medical Devices

This course will explain how to manage a design program that will meet FDA requirements and minimize chances of your medical device being recalled. ISO 13485 has almost identical requirements. Such a program will also help to get projects completed on time and ...

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

The 6 Most Common Problems in FDA Software Validation and Verification

This training on FDA software validation and verification will provide you with the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.

Live Webinar

How to Prepare for and Conduct a Regulatory Audit

In this Regulatory Audit training participants will gain an understanding of how to prepare for and audit, strategies to conduct and support a successful audit, and ways to respond to audit observations. Special consideration will be given to virtual audits as ...

Live Webinar

The Importance of Packaging and Labeling in Pharmaceutical Product Development

Occupying a critical position in the success or failure of any pharmaceutical product launch or revision, Packaging and Labeling form a bridge between the conception of a product and its realization and distribution. Their activities are also crucial for compl ...

Live Webinar

Virtual Assets AML

During this webinar, we will review recent changes to the ACH rules and also discuss upcoming changes that might impact your organization or specifically, your role. Course Objectives: The foundation of ACH and Nacha Understand the rules created by Nacha ...

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Validity : 29th May'23 to 08th Jun'23