Analytical instruments should be qualified and systems should be validated to demonstrate suitability for the intended use. 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 and will provide instruction on how to prepare for FDA audits and how to become part 11 compliant.

Course Objectives:

• 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.

Course Outline:

• Requirements and approaches for Analytical Instrument Qualification
• Going through the qualification phases
• Testing and deviation handling
• Retrospective qualification and Requalification
• Equipment Maintenance and Change control
• Type and extend of qualification for USP Instrument Categories
• Requirements and approaches for Laboratory Computer Systems
• Validation of Laboratory Computer systems
• Validation and Use of Excel in the QC Laboratory
• 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

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 90-minute webinar will be beneficial for the following personnel in pharmaceutical development and quality control laboratories and contract testing laboratories.

• Laboratory managers, supervisors and analysts
• QA managers and personnel
• Quality control unit directors and staff
• IT managers and staff
• Consultants
• Laboratory suppliers of material, equipment and services