Five Essentials for Surviving Your Next Laboratory Inspection: A Quality Control Example, Part 2
Even if you have robust quality systems governing your analytical laboratory and a strong data integrity program in place, you may still be nervous about preparing for a regulatory inspection. What will the inspectors want to know? What will they ask? Is your team prepared?
You can ease those fears by attending this two-part webcast. First, we will explain what you should expect during an inspection. Then, we will simulate an inspection to show you, in a realistic scenario, what an inspector might ask, and how you and your team should handle the questions, including when they don’t know all the answers or don’t understand all the questions. We will explain the scope of a data integrity inspection in a regulated laboratory, and our simulation of an inspection of a chromatography data system (CDS) will explain the roles of different people in a multi-person team that includes a laboratory manager and the CDS laboratory administrator.
What we will cover:
- Set up of a chromatography data system (CDS) and sample analysis
- Peak integration
- Review and e-signatures
- Investigations of out-of-specification (OOS) results and invalidation of OOS results
Key Learning Objectives:
- Understand how data integrity plays a role in your inspection
- Understand and answer the questions being asked
- Understand the impact of poor analytical decisions
- Use systems that can help demonstrate data integrity and regulatory compliance
- Use technical controls to enforce operating procedures
Who Should Attend:
- Analysts working in a regulated analytical laboratory
- Chromatography data system (CDS) administrators
- Laboratory managers
- Quality assurance (QA) and quality control (QC) staff
Presenter: Bob McDowall (Director, RD McDowall Limited, Bromley, Kent, UK)
Bob McDowall, PhD, is an analytical chemist with over 45 years of experience including 15 years working in the pharmaceutical industry and over 25 years working for the industry as a consultant. He is the director of R D McDowall Ltd, a consulting company offering services on process improvement, implementation of laboratory informatics applications, training staff in regulatory compliance, and qualification of IT infrastructure. Bob is a trained auditor and has been involved with the validation of computerized systems for over 30 years. He edited the first book on LIMS in 1987 and is the author of books on the validation of chromatography data systems and data integrity and data governance in regulated laboratories due to be published in late 2018. He was presented with the 1997 LIMS Award. He is a core industry expert for the GAMP Data Integrity Special Interest Group and was a subject matter expert contributor and reviewer of the 2017 GAMP Guide for Records and Data Integrity. He co-drafted the update to USP <1058> on Analytical Instrument Qualification (AIQ) for public comment that became effective in August 2017.
Presenter: Paul Smith (Global Compliance Specialist, Agilent Technologies, Cheadle, UK)
Paul is global compliance specialist with Agilent technologies. He has worked for Agilent for 9 years and has 35 years’ experience in the pharmaceutical and analytical area.
Presenter: Josh Miller (OpenLab Software Marketing – eLearning Expert, Agilent Technologies, Santa Clara, CA)
Josh is a professional chemist with 15 years’ experience in validating, supporting, deploying, and developing the OpenLab software suite of products. He is a true expert with all things OpenLab and has extensive experience with chromatography data system, electronic content management, business process management, instrument control products, and more. He has developed many of the training courses for OpenLab products and has served as an instructor for dozens of formal courses around the globe. In 2009, he created “eFamiliarization” to help customers learn the basics of OpenLab products in an interactive simulation of Agilent software. More recently he has transformed Agilent’s embedded software help systems to better serve customers by putting consistent and searchable content at their fingertips. You may also find a significant collection of video content that he produces to help users learn to use OpenLab products.
