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.
- 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