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Topic:
Six Sigma in Clinical Research
Venue & Date: 1. Mumbai - 28th & 29th March 2009
2. Bengaluru - 23rd & 24th May 2009
Learner Objectives:
• Able to identify and quantify VARIATION in general; as well as in specific context of ‘Clinical Research’
• Familiar with the Concept and Glossary of ‘Six Sigma’
• Able to prepare basic check lists for RCA & interpret simple FEMA tables.
• Able to carry out Business Process Mapping in his own work environment.
• Able to identify, discriminate and prioritize between the factors that affect CONSISTENCY and RELIABILITY in work output.
• Enumerate the advantages and challenges of subscribing to Six Sigma Culture.
• Reason out if Six Sigma is relevant to his job, his team and his organization by suitable examples.
• To ask questions and define problems related to his work environment in this context.
• Work as a team member to design a module in pursuit of ‘Six Sigma’ relevant.
Faculty Objectives:
• To arouse curiosity about the topic.
• To explain concept of ‘Six Sigma’; its genesis and historical background.
• To explain relevance of ‘Six Sigma’ & its applications in Clinical Research.
• To sensitize the participants for a hands-on Workshop at a later date.
About Six Sigma:
Six Sigma stands for Six Standard Deviations. Six Sigma methodology provides the techniques and tools to improve the capability and reduce the defects in any
process. Six Sigma methodologies improve any existing business process by
constantly reviewing and re-tuning the process. To achieve this, Six Sigma uses
a methodology known as DMAIC (Define opportunities, Measure performance,
Analyze opportunity, Improve performance, Control erformance).
Six Sigma & Clinical Research:
Few pharmaceutical firms are listed among more than 300 member companies of the International Society for Six Sigma Professionals (ISSSP). While this suggests that Six Sigma is not extensively deployed by many pharmaceutical companies, CROs & SMOs, use of the methodology can help improve clinical trial performance.
Faculty Constitution:
Course Director
Course coordinator
Quality Management expert
‘Six Sigma’ expert
Clinical Research Faculty from Academia & Industry
Observer
Mehod:
The subject matter will be handled by multi disciplinary Faculty. Didactic Training will be utilized to generate CONTEXT & CONCEPTS. Heavy reliance will be placed on Interactive learning. The atmosphere will enable probing, questioning and reasoned academic disagreements. Feedback will be collected and valued.
Day 1:
| Time |
Topic |
| Before Noon |
|
| 08:30 – 09:00 |
Registration |
| 09:00 – 09:30 |
Introductions; Division in 4 groups |
| 09:30 – 09:45 |
Overview of Plan and audience expectations; Rules for 2 days |
| 09:45 – 10:15 |
Concept of Quality; Six Sigma – Evolution, Relevance; Applications |
| 10:15 – 11:00 |
Statistical Tools for Six Sigma Measures of Central Tendency and Variation |
| 11:00 – 11:15 |
TEA BREAK |
| 11:15 – 12:00 |
Managerial Tools for Six Sigma; e.g.,
• Business Process Mapping
• Failure Mode Effect Analysis & Root Cause Analysis; Action Plan |
| After Noon |
|
| 12:00 – 01:00 |
Group work:
1. To prepare check-lists
2. To comment on FEMA tables
3. To draw FEMA table on a hypothetical situation
4. To interpret results of QA section |
| 01:00 – 02:00 |
LUNCH BREAK |
| 02:00 – 03:00 |
Introduction: Six Sigma Basics |
| 03:00 – 04:00 |
Applications of Six Sigma (Examples & Opportunities) |
| 04:00 – 04:15 |
TEA BREAK |
| 04:15 – 05:00 |
Case Studies in Six Sigma |
| 05:00 + |
Summing up by participants & Feed back |
Day 2:
| Time |
Topic |
| Before Noon |
|
| 08:30 – 09:00 |
WARM UP |
| 09:00 – 09:30 |
Six Sigma in Clinical Research (Implementation Issues) |
| 09:30 – 10:45 |
Identification of Six Sigma Opportunities in own set up (Group Task) |
| 10:45 – 11:00 |
TEA BREAK |
| 11:00 – 12:00 |
Group Task on a given topic
Group I - Root Cause Analysis
Group II - Phase III Clinical Trial |
| After Noon |
|
| 12:00 – 01:00 |
Group Task on a given topic
Group III - Audit
Group IV - FDA inspection preparation
|
| 01:00 – 02:00 |
LUNCH BREAK |
| 02:00 – 02:45 |
Panel Discussion / Open Forum |
| 02:45 – 03:00 |
Summing up |
| 04:00 – 04:30 |
Valedictory Function |
Conferences:
Advance GCP - Theory to Practice, Mum.
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