Process Risk Management Strategies - Reduce Risk and COGS While Improving Yield and Compliance

Date	Nov 9, 2017
Time	02:30 PM EDT
Cost	$250.00
Online

A critical source of risk to patients using pharmaceuticals to improve their health is inadequate design and control of the processes that manufactured the drugs. R&D, Manufacturing, Quality Assurance, Quality Control and Regulatory Affairs play a critical role in reducing risk associated with poorly operating processes. The ICH guidance documents Q8, Q9 and Q10 has heightened awareness in the pharmaceutical and biotech industries of the need to reduce process risk. This trend is also being promoted by the FDA as an approach to process improvement with the benefit of enhanced regulatory flexibility. But the questions remain: What does it mean to reduce risk, to manage risk, and how do you do it? Fortunately we have a lot of experience on which to draw.

Objectives of the Presentation

• Utilizing the relationship between process variation, process understanding, process risk and compliance
• Using a systematic approach to identify the critical few variables that have a major impact on the process: Raw materials, process steps, and process variables and uncontrollable (environmental) variables
• Increasing process stability and capability
• Creating a process control strategy
• Robustness studies of the product and process
• Improvement of measurement performance including improved control and robustness of analytical methods

Why Should you Attend
In this webinar our speaker Ron Snee will discuss the strategies and the associated guiding principles and illustrated with examples and case studies from the pharma and biotech industries. The focus is on reducing risk to reducing cost of goods sold (COGS) while improving process yield and compliance. The discussion also addresses how to make the use of process risk analysis and risk management an integral part of your process management systems, methods and tools.

Instructor Profile:
Ron Snee is the Founder and President of Snee Associates, a firm dedicated to successful implementation of process and organizational improvement initiatives. He provides guidance to senior executives in their pursuit of improved business performance using Quality by Design, Lean Six Sigma and other approaches that produce bottom line results. He has played a leadership role in 32 major improvement initiatives for firms such as Novartis, Schering Plough, Human Genome Sciences, Boehringer-Ingelheim and Kraft Foods. Prior to his consulting career he spent 24 years at the DuPont Company in a variety of assignments including pharmaceutical clinical trial design and analysis. He has developed and applied process design, improvement, monitoring and control methodologies for more than 30 years.

His recent application and research on QbD has produced eight articles on use of QbD in Pharma and Biotech. He has also coauthored 2 books on the methods and tools of QbD and speaks regularly at conferences and meetings on the subject. He is a frequent speaker and has published 5 books and more than 300 papers in the fields of performance improvement, quality, management, and statistics. He is a past recipient of the Institute of Validation Technology Speaker of the Year Award.