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Live Webinar 90 minutes Strategies for Reducing Process


Date
May 28, 2021 - 01:30 PM - May 29, 01:30 PM
Organizer
WCS
Venue
online
Location
WCS Consulting Inc.3190 Stirling Rd, Unit K4 ,Hollywood, FL 33021,

Hollywood,
FL,
US,
ZIP: 33021
Phone: 844-267-7299 | 954-947-5671  


Overview
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.


Who Will Benefit
  • Production managers
  • Process Improvement Professionals
  • Quality Engineers
  • Quality Control and Lab Testing Personnel
  • Research and Development Scientists
  • Biologists and Microbiologists
  • Chemists and Chemical Engineers
  • Process and Manufacturing Engineers
  • Quality Assurance Managers, Scientists and Engineers
  • Regulatory Affairs Professionals


Speaker Details


Instructor Profile:


Ron Snee is the Founder and President of Snee Associates, a firm dedicated to successful implementation of process and organizational improvement initiatives. 

Wcs Seminars
Registration Details
(Contact us : 844-267-7299 | 954-947-5671  
Don't wait. Register TODAY or  Email  US [email protected]


Event Categories
Keywords: pharmaceutical




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