Overview
Process monitoring, control and improvement has been at the heart of quality management for decades. The methodology continues to develop. This webinar discusses some recent advances. The FDA’s 2011 Process Validation Guidance calls for “Continued Process Verification” (CPV). Process monitoring provides the tools for enabling CPV and dealing with variation. Managing and reducing variation is at the heart of the FDA Process Validation Guidance. Clearly stated in the guidance is the need to understand variation, ability to detect variation, understand the impact of variation and ability to control variation.
This webinar addresses the concepts, methods and tools used in process monitoring, control and improvement and in turn continued process verification. It is shown how the tools are integrated to create a SYSTEM that links process monitoring, control and improvement. This system enhances the use of the tools and the effectiveness of continued process monitoring, control and improvement. The approach is illustrated with a variety of case studies including pharmaceuticals.
Webinar Takeaway
- Current Approaches: Strengths, Limitations and Tools
- Systematic approach – Roadmap and Tools
- Use of Define, Measure, Analyze, Improve and Control (DMAIC) problem solving model for problem solving and improvement
- Integrating Corrective Action and Prevention
- Sustaining the Elimination of process problems
- Importance of Periodic Management Review
- Systematic Approach for Deviation Reduction
- Tips, Traps and guidelines for successful continued process verification
Learning Objectives
- Learn the Strengths and Limitations of Current Approaches to Process Monitoring
- Systematic Approach to Process Monitoring, Control and Improvement:
- What it is, Why it is Needed and How to Implement the Approach
- How to Sustain process stability and capability
- Importance of Periodic Management Review
- Tips, Traps and guidelines for successful continued process verification
Who will Benefit
- Production Managers
- Quality Assurance Managers, Scientists and Engineers
- Research and Development Scientists
- Product Development Personnel
- Lab Testing Personnel
- Biologists and Microbiologists
- Chemists and Chemical Engineers
- Process and Manufacturing Engineers
- Quality Engineers
- Supply Chain Professionals
- Process Improvement Professionals
Industries who can attend
This 60-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel
Faculty Ron Snee
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.
