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  Conferences:

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


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 Advance GCP - Theory to Practice, Mum. Top


 
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