Data Integrity 2024: A Virtual Symposium

Are you keeping up to date with the latest thinking on data integrity? To ensure data integrity, it is essential to understand the latest regulatory guidance, issues and approaches. Join us for this free, interactive workshop to quickly get up to speed! You’ll leave with a better understanding of important recent regulatory issues and changes and what those mean for your laboratory. Each session will start with a presentation, which will include a question-and-answer period. That will be followed by an interactive workshop to reinforce the principles of each subject presented. Sign up today!

Register Free:
https://www.chromatographyonline.com/lcgc_w/data-integrity-2024

Event Overview:

To ensure that your data integrity programs work, it is essential to keep up to date with current regulatory trends—monitoring both new regulatory guidance documents and trends in non-compliance. In this interactive event, we will ensure that you understand the impact of recent and proposed updates, by addressing four topics:

1. Chromatographic Peak Integration: Ensuring Integrity and Scientific Soundness
2. Analytical Procedure Lifecycle: How do the new versions of ICH Q2(R2) and Q14 compare with USP <1220>?
3. Analytical Instrument Qualification and System Validation Risk assessment: Where is USP <1058> going now; a practical approach?
4. Computerized System Validation (CSV) as part of Analytical Instrument Qualification and System Validation Risk assessment; a practical approach

These topics will be discussed within the framework of the data integrity model that sits within the overall pharmaceutical quality system of a regulated laboratory. Analysis takes place at Level 3 in this model, but to ensure both data quality and integrity it is imperative that the elements of the Foundation and Levels 1 and 2 are in place. The analogy of this model is building a house: It collapses if not built correctly.

We will tackle one topic per session. Each session will start with a presentation, which will include a question-and-answer period. This will be followed by an interactive workshop to reinforce the principles of each subject presented. For the workshop portions, participants will be asked to engage in answering questions and sharing ideas—anonymously—using a free web-based platform called Mentimeter (menti.com), which can be used through a web browser on any computer or smartphone. No download or prior preparation is required; the link and a code will be provided during the event.

This virtual symposium on data integrity is aimed at chromatographers and quality assurance professionals who have a working knowledge of data integrity within a regulated GXP laboratory. Thus, basic knowledge, such as an understanding of GMP regulations and ALCOA++ criteria, will be assumed.

Top Reasons to Attend

• Get up to date with current regulatory trends in data integrity issues with peak integration of chromatograms
• Learn how the final versions of ICH Q2(R2) and Q14 compare with USP <1220> regarding the Analytical Procedure Lifecycle
• Find out where the revision of USP <1058> on Analytical Instrument Qualification is heading now
• Understand the Risk Assessment Process and the implications for Practical Qualification
• Extend the principles of the Risk Assessment Process into Practical Approaches for System Validation
• Learn from interactive workshops to strengthen your understanding of these essential concepts in data integrity and how to spot and resolve problems.
• Download a copy of the 153 page European Compliance Academy (ECA) Guide on An Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation by joining the ECA AQCG, which is free. Membership Registration (analytical-quality-control-group.org)
  (This Guide is the basis for the Day 2 presentations and on-line workshops).
  
  

Who Should Attend

Chromatographers from Analytical Development and Quality Control Departments along with Quality Assurance personnel who are involved in data integrity, method development and validation, qualification of chromatographs and computer validation projects. Attendees should have a working knowledge of data integrity principles and GMP regulations.


Session Details

Day One, Monday, April 15, 2023
 
Morning Session, 10:00 am–12:15 pm EST
Peak Integration Meets Regulatory Compliance

10:00–11:00 EST: Chromatographic Peak Integration: Ensuring Integrity and Scientific Soundness
Bob McDowall, R D McDowall Ltd, UK

11:15 am–12:15 pm EST: Interactive Workshop: Reviewing Peak Integration
Bob McDowall, R D McDowall Ltd, UK
 

Lunchtime Session, 12:30 am–1:15 pm EST
Data Integrity Tools, Tips and Best Practices from Our Sponsors


12:30pm Data Management and Prediction to Support High-Throughput Purification
Jun Wang, Scientist (Medicinal Chemist), Merck
 
12:50pm Supporting Environmental Testing and Research Laboratories with Reliable Analytical Reference
Materials: the analytical characterisation of diverse per- and polyfluoroalkyl substances (PFAS) from
technical mixtures to isomer mixtures and pure linear isomers
Dr. Craig McKenzie, Quality Control and Analytical Research Manager, Chrion AS

Afternoon Session, 2:00–4:30 pm EST
A Critical Review of the Final Versions of ICH Q2(R2) and ICH Q14 for Analytical procedure Lifecycle Management
 
2:00–3:00 pm EST Analytical Procedure Lifecycle: How does the new versions of ICH Q2(R2) and the first version of ICH Q14 compare with USP <1220>?
Chris Burgess, Burgess Analytical Consultancy Ltd, UK
 

3:30-4:30 pm EST Interactive Workshop: Critique of a traditional HPLC method; Expectations over the lifecycle
Chris Burgess, Burgess Analytical Consultancy Ltd, UK
 

Day Two, Tuesday, April 16, 2024

Morning Session, 10:00 am–12:15 pm EST
Update on USP <1058>

10:00–11:00 am EST: AIQSV Part 1: Risk Assessment and Practical Instrument Qualification
Chris Burgess, Burgess Analytical Consultancy Ltd, UK
 

11:15 am–12:15 pm EST: Interactive Workshop: AIQSV: Practical Approaches for Qualification of Analytical Instruments
Chris Burgess, Burgess Analytical Consultancy Ltd, UK 

 
Afternoon Session, 2:00–4:30 pm EST


2:00–3:00 pm EST: AIQSV Part 2: Risk Assessment and Practical System Validation: From Chromatograph to CDS to the Cloud
Bob McDowall, R D McDowall Ltd, UK 
 
The session will include a live question-and-answer (Q&A) period.

3:30–4:30 pm EST: Interactive Workshop: From Chromatograph to CDS to the Cloud
Bob McDowall, R D McDowall Ltd, UK 

Speakers:

Chris Burgess is an analytical scientist with more than 48 years of experience in the pharmaceutical industry, initially with Glaxo in Analytical R&D, Quality Control, and Quality Assurance, and then in international consultancy. He is a “Qualified Person” in the European Union. He was appointed to the United States Pharmacopoeia’s Council of Experts 2010 to 2015 and re-elected for 2015 to 2020 and 2020 to 2025. He is currently the chair of the USP Joint Sub Committee for the revision of chapter <1058>. He was also a member of the USP Expert Panel on Validation and Verification which generated General Chapter <1220>. He is a visiting Professor at the University of Strathclyde in the Strathclyde Institute of Pharmaceutical and Biomedical Sciences and an editorial board member for Pharmaceutical Technology Europe for whom writes the “Statistical Solutions” column.

Bob McDowall, RD McDowall Ltd, UK
Bob McDowall is an analytical chemist with 50 years of experience, including working in the pharmaceutical industry for 15 years and then working for the industry as a consultant for 29 years. Bob has been involved with the validation of computerized systems for more than 35 years and is the author of a book on the validation of chromatography data systems. His latest book is Data Integrity and Data Governance: Practical Implementation for Regulated Laboratories, published in 2019 by the Royal Society of Chemistry. He is a member of the GAMP Data Integrity Special Interest Group, contributing to the Records and Data Integrity Guide in 2017 and two Good Practice Guides. Bob is also the author of the “Questions of Quality” and “Focus on Quality” columns in LCGC Europe and Spectroscopy magazines, respectively.

Register Free:
https://www.chromatographyonline.com/lcgc_w/data-integrity-2024