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FDA Regulations for Analytical Instrument Qualification and Validation Processes Webinar  

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Online Compliance Panel   

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Laboratory managers, supervisors and analysts, IT managers and staff, Consultants, Laboratory suppliers of material, equipment and services

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Seminar Summary:

In this webinar you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Through case study analysis we will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system.Additionally, case studies will explore how your management practices of your analytical equipment qualification/ validation and process validation programs can help or hurt your legal liability and the legal issues that arise from nonconformance with regulators and Auditors. (see full course description)

 

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Training Course Syllabus:


Objectives of the Presentation

Learn about the regulatory background and requirements for laboratory instrument qualification and system validation
Understand the logic and principles of instrument qualification and system validation from validation planning reporting
Understand and be able to explain your company´s qualification and validation strategies
Be able to independently prepare execute test protocols, this includes setting specifications and acceptance criteria
Understand how to review and approve qualification and validation protocols
Be able to develop inspection ready qualification and validation deliverables
Learn how to avoid and/or respond to FDA inspectional observations and warning letters

Why Should you Attend

The cost of non-compliance is therefore more than that of compliance. Are you in compliance with the FDA regulations for analytical equipment qualification and validation in your facility? This 90 minute webinar will provide attendees the regulatory background and guidance through the complete process from planning and writing requirement specifications to vendor assessment, installation and operational qualification and ongoing testing during routine use. This webinar will help attendees understand the instrument qualification and system validation processes.

Areas Covered

Requirements and approaches for Analytical Instrument Qualification
Risk based validation approach
Going through the qualification phases
User requirements, writing the specifications
Testing and deviation handling
Proper documentation
Type and extend of qualification for USP Instrument Categories
Periodic review and revalidation analytical instruments and equipment
Wrap up - Final questions and answers

Who will Benefit

Laboratory managers, supervisors and analysts, IT managers and staff, Consultants, Laboratory suppliers of material, equipment and services, Senior quality managers, Quality professionals, Regulatory professionals, Compliance professionals, Production supervisors, Validation engineers, Manufacturing engineers, Production engineers, Design engineers, Process owners, Quality engineers, Quality auditors

Seminar Summary:

In this webinar you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Through case study analysis we will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system.Additionally, case studies will explore how your management practices of your analytical equipment qualification/ validation and process validation programs can help or hurt your legal liability and the legal issues that arise from nonconformance with regulators and Auditors. (see full course description)

print this agenda print agenda for the FDA Regulations for Analytical Instrument Qualification and Validation Processes Webinar training seminar

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