Improving Process Stability and Capability - Tips, Traps and Guidance

Duration: 90 Minutes
Learn the "What", "Why" and "How" of improving process capability and stability. Topics discussed include: FDA Guidance, pharma and biotech industry experience, pitfalls to avoid, sampling procedures and data quality.
FDA Process Validation Guidance
Instructor: Ronald D. Snee
Product ID: 508219
Objectives of the Presentation
  • Implement FDA Process Validation Guidance
  • Create and implement Continued Process Verification Systems
  • How to Select the Right Control Chart
  • Reducing False Out of Control Signals
  • How to Use Process Stability Metrics
  • Selecting Appropriate Sampling Procedures
  • Identifying Causes of Out-of-Control Signals - The Usual Suspects
  • Early Warning Devices for Detecting Process Shifts
  • Assessing the Pedigree of Your Data
Why Should you Attend
FDA’s Process Validation Guidance Stage 3 calls for "ongoing assurance is gained through routine production that the process remains in a state of control." Two critical considerations in assessing process behaviour are process stability and capability. Tools commonly used to demonstrate that a process is in a state of control include: control charts, process capability indices, analysis of variance and graphics. Unexpected problems are often encountered when using these tools. In this session "tips and traps" are discussed that enable pharmaceutical scientists and engineers to develop effective process monitoring systems and avoid commonly encountered problems and pitfalls.

The issues discussed include: how to reduce false out of control signals, measures of process stability, how to identify causes of out of control signals, how to select the appropriate sampling procedures. The approaches and tools discussed are illustrated with pharmaceutical and biotech case studies and examples.

Areas Covered
  • Reducing False Out of Control Signals
  • How to Use Process Stability Metrics
  • Selecting Appropriate Sampling Procedures
  • Identifying Causes of Out-of-Control Signals - The Usual Suspects
  • Early Warning Devices for Detecting Process Shifts
  • How to Select the Right Control Chart
  • Can We Reduce Sampling
  • Assessing the Pedigree of Your Data
  • Tips, Traps and Guidance - What to Watch Out For
Who will Benefit
  • Production Managers
  • Process and Manufacturing Engineers
  • Quality Assurance Managers, Scientists and Engineers
  • Quality Engineers
  • Lab Testing Personnel
  • Research and Development Scientists
  • Product Development Personnel
  • Biologists and Microbiologists
  • Chemists and Chemical Engineers
  • Supply Chain Professionals
  • Process Improvement Professionals
$375
Recorded Session for one participant
Get life time access with download option!
Book this course
Pay Now
  $500.00 Training CD
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
  $600.00 Training USB Flash Drive
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
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.


View More