QbD & PAT - The Scientist Is No Longer In The Laboratory, But Integrated In The Overall Quality Process
Sponsored by: Industrial Lab Automation
Date: 4 October
Time: 3PM London / 10AM New York
Economic Pressures to Reduce Effort on Compliance and Improve Quality have Accelerated the Adoption of Quality by Design and PAT
The industry is looking at more holistic approaches to improve processes of bringing new products to market that can accelerate product development and lower operational costs. Quality by Design (QbD) has come relatively late to the pharmaceutical industry. In terms of quantifiable benefits, the main QbD value comes from four main areas; (1) a reduction of Cost of Goods Sold (COGS) and capital expense, (2) increased technical development productivity, (3) improved quality and lower risk, and (4) increased sales.
During this practical webinar learn how QbD principles combined with PAT technologies will facilitate and implement a robust pharmaceutical quality system according to ICH Q10 in the development and manufacturing. Practical examples will show how QbD will enable you to gain the benefits of establishing and maintaining a state of control, continual improvement, enhancing regulatory compliance and meeting quality objectives.
Leadership, outstanding processes, and culture are the ingredients for making companies successful. Technologies are just enablers to achieve that goal. This webinar explores the journey and its role in driving QbD and Pat adoption within Pharma and gives answers of some of the concepts behind the QbD concept.
Peter J. Boogaard,
Peter Boogaard is a customer first, results-driven innovated senior executive with over 25 years of significant contributions to knowledge management automation. He is founder of Industrial Lab Automation which provides services to address harmonization, integration and consolidation of business processes in Life Science development and manufacturing enabling cross-functional collaboration between research, development, quality assurance and manufacturing corporations to achieve Quality by Design (QbD) initiatives. Strong demands to help companies optimizing their processes to break their barriers across development and manufacturing resulted in teaming up with Vialis AG. Vialis is the leading provider of paperless lab for the chemical and pharmaceutical industries. Peter has published several white papers and contributes in several industry advisory boards.
Download SlidesPlease login to download the slides
Key Learning Objectives
- Introduction to QbD concept and update on ICH Q10 and QbD Pharmaceutical Quality Systems guideline
- Overview of PAT technologies and industry examples in both development and manufacturing
- Introductory overview of Product Quality Lifecycle Implementation (PQLI) and Introduction to the 4 Product Quality System elements (PQS)
- Introduction to paperless lab initiative, to help you eliminate the informatics information silo’s
- CEO/President/Chairman/Executive Director
- Senior Technical Directors
- Senior Heads of Quality Compliance
- Process Development Scientists
- Senior PAT and QbD Specialists and experts
- Project Managers
- Senior Scientific Advisors and Inspectors
- Senior Scientists