Five Essentials for Surviving Your Next Laboratory Inspection: A Quality Control Example
Nervous about regulatory inspections of your laboratory? Fear no more! Attend this two-part webcast to learn what to expect during a regulatory inspection, so that you can prepare with confidence. Our experienced team will simulate an inspection and show you how to handle questions and doubts, and what the inspectors will need to see when reviewing your chromatography data system (CDS) and data integrity training. Part 1: Friday, May 1, 2020 at 9am EDT | 2pm BST| 3pm CEST Tuesday, May 12, 2020 at 1pm EDT | 12pm CDT | 10am PDT Part 2: Thursday, May 28, 2020 at 9am EDT | 2pm BST | 3pm CEST Tuesday, June 9, 2020 at 1pm EDT | 12pm CDT | 10am PDT On demand available after final airing until May 28, 2021
Register free: http://www.chromatographyonline.com/lcgc_w/quality_control_example_series
Event Overview:
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:
Five Essentials for Surviving Your Next Laboratory Inspection: A Quality Control Example, Part 2 (watch live on May 28 or June 9)
- 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
Join us to learn and ease your fears!
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
Speakers: Bob McDowall, Director, RD McDowall Limited, Bromley, Kent, UK
Paul Smith, Global Compliance Specialist, Agilent Technologies, Cheadle, UK
Josh Miller, OpenLab Software Marketing – eLearning Expert, Agilent Technologies, Santa Clara, CA
Time and Date:
Part 2: Thursday, May 28, 2020 at 9am EDT | 2pm BST | 3pm CEST
Tuesday, Jun. 9, 2020 at 1pm EDT | 12pm CDT | 10am PDT
Sponsor: Agilent Technologies
Register free: http://www.chromatographyonline.com/lcgc_w/quality_control_example_series
