Ensuring performance and meeting regulatory requirements in the pharmaceutical industry Installation Qualification (IQ) and Operational Qualification (OQ) are 'validation and verification' quality assurance standards used throughout the pharmaceutical industry to ensure instruments used in laboratories fulfil and conform to legal requirements and guidance for cGMP as specified by U.S. FDA, Health Canada and other non-U.S. pharmaceutical quality management requirements.
Presented by
Ken Phillips,
Market Development Manager - HunterLab
Ken Phillips is market development manager at HunterLab in Reston, Virginia, USA. Ken has many years of experience in developing color measurement and management solutions for industry.
Learning objectives
- Validation and Qualification – understanding the ‘Q’ process
- Documented testing – confirming proper Installation, Operation and Performance
- Recording instrument history – ensuring your instrument follows GLP and GMP guidelines
- Audit trails – meeting internal and external validation requirements
Audience
- Quality Control
- R&D
- Management Personnel
