Data Integrity 2022: A virtual symposium

Register Free: https://www.chromatographyonline.com/lcgc_w/data_integrity

Event Overview

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.

In this interactive event, we will address four topics, which are essential for ensuring data integrity:

1. An Update on New Regulatory Guidance Documents and Recent Regulatory Citations
2. USP <1058> on Analytical Instrument Qualification and Considerations for Enhancement to a Full Life Cycle Process
3. Putting What’s Wrong with Computerised System Validation Right
4. Understanding the New USP Chapter <1220> on Analytical Procedure Life Cycle (APL)

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 for accessing the workshop screens will be provided during the event.

Key Reasons to Attend

• Keep up to date with current regulatory trends—including new regulatory guidance documents and recent trends in non-compliance.
• Understand the impact of proposed changes to USP <1058> for Analytical Instrument and System Qualification
• How the new USP <1220> lifecycle approach impacts the development, validation, and operation of analytical procedures
• Learn why a business-driven approach to validating a chromatography data system increases lab efficiency and reduces the amount of work you have to do
• Learn from interactive workshops to strengthen your understanding of these essential concepts in data integrity and how to spot and resolve problems.

Who Should Attend?

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

Speakers

Dr. Bob McDowall
Analytical Chemist
R D 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 t han 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.

Chris Burgess
Analytical Scientist
Burgess Analytical Consultancy Ltd., UK

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.

Register Free: https://www.chromatographyonline.com/lcgc_w/data_integrity