Deep Dive Workshop METTLER TOLEDO

Presenter: Bob McDowall, director at R D McDowall LT

Experienced Principal with a demonstrated history of working in the pharmaceutical and allied industries on computerised system validation, management consultancy , 21 CFR 11 and data integrity. Skilled in Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP). Change Control, Computerised System Validation, and Laboratory Automation. Trained auditor. Writer of articles and books as well as white papers for clients. Published articles can be found here: www.rdmcdowall.com/library

Bob is an auditor and he has been involved with the validation of computerized systems for over 30 years and is the author of books on the Validation of Chromatography Data Systems (two editions 2005 and 2017) and this year published his book on Data Integrity and Data Governance - Practical Implementation in Regulated Laboratories.

Bob is also the writer of the Questions of Quality (LC-GC Europe) and Focus on Quality (Spectroscopy) columns and is a member of the Editorial Advisory Boards of several Journals. He is also involved in the GAMP Data Integrity Special Interest Group and is a contributor and reviewer of the 2017 GAMP Guide for Records and Data Integrity and the Good Practice Guide on Data Integrity - Key Concepts.

Reference Last edition: Data Integrity and Data Governance: Practical Implementation for Regulated Laboratories Royal Society of Chemistry 2019

Presenter: Carlos Rosas, Global Business Development Manager @ Mettler Toledo International

Carlos Emilio Rosas is Global Business Development Manager for Software Solutions and LabX Consulting at Mettler Toledo International.

With an industrial engineering education and a keen interest in processes, software, and facilitation; he focuses on solutions for Data Governance, Data Integrity, workflow guidance and efficiencies.

He helps businesses and their laboratories to reach the Paperless Lab goals by integrating benchtop instruments into the lab ecosystem with LabX as part of its Digital Transformation.

He is a member of a team providing consulting, seminars, and training on solutions that support Data Integrity within the Production, QC and R&D environment. He also supports companies where a common solution or standardization over multiple countries and regions is required.19

Objectives of this session

This interactive workshop encourages participant input and comment. It will start with the presentation of a case study process flow for stability testing.

Attendees will be asked to identify process problems, bottlenecks and data integrity vulnerabilities.

How should this process be improved to generate business efficiencies?

Then attendees will be asked to identify quick wins (short projects with large business benefit) and digitalisation projects to automate the entire process.

Next, how to sell the concept of digitalisation to senior management:

where are the best gains realised?
Are they in the lab or in the wider organisation?

We will then turn to sample preparation and discuss how can the current processes be digitalised.

How can sample preparation data be transferred to a chromatography data system?
Can the LIMS in this process be made more efficient?

METTLER TOLEDO specialises in the area of precision instruments for laboratory and industrial production. Our instruments are used in R&D research, drug discovery, and quality control labs in the pharmaceutical, chemical, food and cosmetics industries.
We are a global market leader with the three instrument groups most frequently used in the laboratory (balances, pipettes, and pH meters), and we are a pioneer in the field of Automated Chemistry. Our comprehensive software solutions grants full automation and integration of our vast instrument portfolios within existing system infrastructures, boosting laboratory efficiency while also maintaining full compliance to data integrity regulations.

[ DEEP DIVE WORKSHOP] How Would You Digitalise A Mess?

Objectives of this session