Two Day Virtual Training Course: Analytical Instrument Qualification and Validation - Understanding Use of Excel and FDA Audit Preparation (July 25-26, 2022) - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Analytical Instrument Qualification and Validation - Understanding Use of Excel and FDA Audit Preparation" training has been added to ResearchAndMarkets.com's offering.

In the two-day workshop conference, 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.

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 seminar will help attendees understand the instrument qualification and system validation processes and provide instruction on preparing for FDA audits and becoming part 11 compliant.

Areas Covered:

• 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 and execute test protocols, this includes setting specifications and acceptance criteria
• Understand how to review and approve qualification and validation protocols
• Understand Validation and Use of Excel in the QC Laboratory
• Learn about Handling raw data and other laboratory records
• Be able to develop inspection ready qualification and validation deliverables
• Learn how to avoid and/or respond to FDA inspectional observations and warning letters

   

Key Topics Covered:

DAY 1

Lecture 1

• Requirements and approaches for Analytical Instrument Qualification
• Going through the qualification phases

Lecture 2

• Testing and deviation handling
• Retrospective qualification and Requalification

Lecture 3

• Equipment Maintenance and Change control
• Type and extend of qualification for USP Instrument Categories

Lecture 4

• Requirements and approaches for Laboratory Computer Systems
• Examples for risk assessment of computer systems

DAY 2

Lecture 5

• Validation of Laboratory Computer systems
• Preparing inspection ready validation documentation

Lecture 6

• Validation and Use of Excel in the QC Laboratory
• How to ensure spreadsheet and data integrity

Lecture 7

• Periodic review and revalidation of chromatographic data system
• Handling raw data and other laboratory records
• Ensuring Integrity and Security of Laboratory (Raw) data

Lecture 8

• Auditing Laboratory Computer Systems and records for FDA Compliance
• Learn how to avoid or respond to FDA 483s and warning letters

   

For more information about this training visit https://www.researchandmarkets.com/r/wryv5l

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