Five Essentials for Surviving Your Next Laboratory Inspection: A Quality Control Example (Asia Pacific)

August 12, 2020
Agilent Technologies

Sponsored Content

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: Tuesday, September 15, 2020 China/Singapore/Malaysia/Philippines – 2:00pm Indonesia/Thailand/Vietnam – 1:00pm Australia/New Zealand – 4:00pm Central Europe – 8:00am India – 11:30am Part 2: Thursday, September 17, 2020 China/Singapore/Malaysia/Philippines – 2:00pm Indonesia/Thailand/Vietnam – 1:00pm Australia/New Zealand – 4:00pm Central Europe – 8:00am India – 11:30am On demand available after final airing until Sept. 17, 2021.

Register free: http://www.chromatographyonline.com/lcgc_w/five_essentials1

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 1

  • Background on data integrity and a chromatography data system (CDS)
  • Management involvement in data integrity
  • Qualification of chromatographs
  • Validation of analytical procedures

Five Essentials for Surviving Your Next Laboratory Inspection: A Quality Control Example, Part 2

  • 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 1: Tuesday, September 15, 2020
China/Singapore/Malaysia/Philippines – 2:00pm
Indonesia/Thailand/Vietnam – 1:00pm
Australia/New Zealand – 4:00pm
Central Europe – 8:00am
India – 11:30am

Part 2: Thursday, September 17, 2020
China/Singapore/Malaysia/Philippines – 2:00pm
Indonesia/Thailand/Vietnam – 1:00pm
Australia/New Zealand – 4:00pm
Central Europe – 8:00am
India – 11:30am

On demand available after final airing until Sept. 17, 2021.

Sponsor: Agilent Technologies

Register free: http://www.chromatographyonline.com/lcgc_w/five_essentials1