Data Integrity 2023: A Virtual Symposium

Join us for this free, interactive workshop to quickly get up to speed! You’ll leave with an in-depth understanding of important recent changes and what those mean for your laboratory.

Register Free: https://www.chromatographyonline.com/lcgc_w/data-integrity-2023

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. An update on Proposed Regulations for Computerized Systems and Updated FDA Guides
2. Analytical Procedure Lifecycle: How do the draft versions of ICH Q2(R2) and Q14 compare with USP <1220>?
3. Where is USP <1058> on Analytical Instrument Qualification going now?
4. Computer Software Assurance (CSA) versus Computerized System Validation (CSV)

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—fully anonymously—using a free web-based platform called Mentimeter (menti.com), which can be used through a web browser on any computer or phone. 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

• Understand proposed regulations for computerized systems and updated FDA guidelines
• Learn how the draft versions of ICH Q2(R2) and Q14 compare with USP <1220> regarding the Analytical Procedure Lifecycle
• Find out where USP <1058> on Analytical Instrument Qualification is heading now
• Understand the differences between Computer Software Assurance (CSA) and Computerized System Validation (CSV)—and why you should care
• Learn from interactive workshops to strengthen your understanding of these essential concepts in data integrity and how to spot and resolve problems.

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-2023