Global agencies across the world have varied expectations of analytical equipment qualification which will be discussed in this webinar.  You will also learn how to develop a sound process validation program in order to implement invulnerable solutions that are accepted, effective, and efficient. This webinar will help you develop or improve your current system using industry best practices which will be highlighted using case studies. Additionally, through our case studies will explore how your management practices of analytical equipment qualification/ validation and process validation programs can either help or hurt your legal liability and issues that stem from nonconformance with regulators and Auditors.

It’s a known fact that the cost of non-compliance outweighs that of compliance. This webinar will help you answer this essential question: Are you in compliance with the FDA regulations for analytical equipment qualification and validation in your facility? This seminar will help attendees prepare for FDA audits and how to become part 11 compliant, as well as help all participants understand instrument qualification and system validation processes. 

Course Outline:

• 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

Agenda:

Session 1

• Requirements and approaches for Analytical Instrument Qualification

• Going through the qualification phases

• Testing and deviation handling

• Retrospective qualification and Requalification

Session 2

• Equipment Maintenance and Change control

• Type and extend of qualification for USP Instrument Categories

• Requirements and approaches for Laboratory Computer Systems

• Examples for risk assessment of computer systems

Session 3

• Validation of Laboratory Computer systems

• Preparing inspection ready validation documentation

• Validation and Use of Excel in the QC Laboratory

• How to ensure spreadsheet and data integrity

Session 4

• Periodic review and revalidation of chromatographic data system

• Handling raw data and other laboratory records

• Ensuring Integrity and Security of Laboratory (Raw) data

• Auditing Laboratory Computer Systems and records for FDA Compliance

• Learn how to avoid or respond to FDA 483s and warning letters

What You Get:

• Training Materials

• Live Q&A Session with our Expert

• Participation Certificate

• Access to Signup Community (Optional)

• Reward Points

Who Will Benefit:

This seminar will be beneficial to personnel in pharmaceutical development and quality control laboratories and contract testing laboratories as well as Individuals that have Quality Management Systems responsibilities for making general improvements in their organization’s performance specifically related to equipment and processes. Following personnel will benefit from the course:

• 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