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Practice Makes Perfect:  Training and Performing in the Pharmaceutical Industry Sunil Gupta Quintiles
Each employee faces challenges and obstacles along their pharmaceutical career paths.  http://www.freeimages.co.uk/
Practice Makes Perfect ,[object Object],Pharmaceutical Industry
Practice Makes Perfect ,[object Object],Pharmaceutical Industry Training
Practice Makes Perfect ,[object Object],Pharmaceutical Industry Training Performing
What is  unique  about the pharmaceutical industry? Clients/Partners Products/Services Employees/Managers
Clients working together as CRO Partners Four C’s in CRO business CRO team members Key Performance Indicators (KPI)
Knowing the Four C’s in CRO business ,[object Object],[object Object],[object Object],[object Object],Vogel, J.R., "A Practical Approach to Achieving Success with CROs" http://www.jrvogel.com/training.html C
CRO team members are seamlessly integrated with the client ,[object Object],[object Object],[object Object],[object Object]
Key Performance Indicators (KPI) are important to monitor improvements ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Products and services helping to reach drug sales goals 21 CFR Part 11 requirement Standard macros QC and delivery
Following the 21 CFR Part 11 rule  is a requirement ,[object Object],[object Object],[object Object],[object Object],Code of Federal Regulations ,  http:// www.fda.gov/oc/gcp / , http://www.21cfrpart11.com/pages/faq/index.htm
Standard macros help to automate common tasks ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
QC and delivery expectations should be met ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],On Schedule   10 to 15  simple tables/day   Expect Delays   1 complex table /2 – 3 days
Employees and managers sharing a common vision Communication, Communication, Communication ‘ Sharpen the Saw’ Industry-Related Magazines One-on-one meetings
Communication,  Communication, Communication ,[object Object],[object Object],[object Object],[object Object],[object Object],Meet As Needed E-mail, IM Frequently Phone Often
Everyone should take time to ‘Sharpen the Saw’ ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Stay Current with Industry-Related Magazines (Articles by Sunil Gupta) ,[object Object],[object Object],[object Object],[object Object],[object Object]
One-on-one meetings at least  once a month ,[object Object],[object Object],[object Object],[object Object]
Practice Makes Perfect ,[object Object],Pharmaceutical Industry Training “ Behavioral change is required for learning”   - David Garvin, Harvard Business Review 1993
Developing an  effective  training program Client Requirements Best Practices Corporate Ladder
Training Program meets client’s requirements Client working environment Real-world programming tasks Monitor, evaluate and provide feedback
Simulate client working environment to prevent surprises ,[object Object],[object Object],[object Object],[object Object]
Assign real-world programming tasks using client tools ,[object Object],[object Object],[object Object],[object Object],[object Object],Client  Legacy Clinical Study
Monitor, evaluate and provide feedback Minimum feedback and yearly monitoring  Performance reviews  Mentor by Director General feedback and monthly monitoring  One-to-one meetings  Mentor by Senior/Manager Detail feedback and close monitoring  Daily or every other day Mentor by Senior/Manager  Senior/Manager   Junior   Entry
Monitor, evaluate and provide feedback Minimum feedback and yearly monitoring  Performance reviews  Mentor by Director General feedback and monthly monitoring  One-to-one meetings  Mentor by Senior/Manager Detail feedback and close monitoring  Daily or every other day Mentor by Senior/Manager  Senior/Manager   Junior   Entry
Best Practices training program Continuous  Improvement Train Feedback Update “ Plan, Do, Check, Act” ,  Deming Mastery of  SAS Programming Understanding of  Clinical Trials Data
Mastery of SAS Programming is essential ,[object Object],[object Object],[object Object]
Understanding of Clinical Trials Data is important  ,[object Object],[object Object],[object Object],Look for information on SAS Clinical Trials for Statistical Programming Certification exam at PharmaSUG 2009
Climbing the corporate ladder Entry (< 2 yrs) Junior (2 – 5 yrs) Senior/ Manager (>= 5 yrs) Responsibilities Training
Titles and general responsibilities  need to be understood and applied - Critical Thinker - Efficacy Programming - Maintain Program Index excel file - Tools/Macro Development - Effective Delegator - Source Programming - Annotated Graphs - Macro Validation Programming - Opportunity for leadership roles - Validation Programming of simple listings - Edit Checks - Simple Data Listings  Lead Programmer  Statistical Programmer II Statistical Programmer I   Senior/Manager   Junior   Entry
Titles and general responsibilities  need to be understood and applied - Critical Thinker - Efficacy Programming - Maintain Program Index excel file - Tools/Macro Development - Effective Delegator  - Source Programming - Annotated Graphs - Macro Validation Programming - Opportunity for leadership roles - Validation Programming of simple listing - Edit Checks - Simple Data Listings  Lead Programmer  Statistical Programmer II Statistical Programmer I   Senior/Manager   Junior   Entry
Training program needs to match expected deliverables by position ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Mosher, Bob, “Informal Learning: Are We Missing a HUGE Opportunity?,” ASTD 2008, research by Dr. Conrad Gottfredson
Practice Makes Perfect ,[object Object],Pharmaceutical Industry Training Performing “ Teaching the employee to perform effectively”  - Bob Mosher, Learning Guide Solutions 2008
Performing  in the pharmaceutical industry Poor and Good  Performance
Red flags of poor performance Screen candidates for skills SAS programming skills need improvement Communication of clinical issues is poor
Screen candidates for relevant skills  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Ask interview team members to rate each candidate
SAS programming skills need improvement ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Communication of clinical issues is poor ,[object Object],[object Object],[object Object],Biostatisticians Clinical Data Management Data Issue Statistical Programming
Critical success factors of good performance  Highly Motivated Employees Searches to understand the ‘why’ Becomes more productive with experience Follows trends for increased productivity
Highly motivated to learn multiple ways for complete programming task ,[object Object],[object Object],[object Object],[object Object],[object Object]
Searches to understand the  ‘why’ behind SOPs and SDLC ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Becomes more productive  with experience ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Applies trends for increased productivity ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],M O R E L E S S
In summary, challenges in the  pharmaceutical industry can be overcome  Effective Communication Early identification of Safety Issues Understanding Clinical Data Following FDA Requirements
Through effective partnership, training and commitment, you are better prepared for the next level.   http://www.freeimages.co.uk/
Practice Makes Perfect:  Training and Performing in the Pharmaceutical Industry Sunil Gupta [email_address] Quintiles

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Practice Makes Perfect

  • 1. Practice Makes Perfect: Training and Performing in the Pharmaceutical Industry Sunil Gupta Quintiles
  • 2. Each employee faces challenges and obstacles along their pharmaceutical career paths. http://www.freeimages.co.uk/
  • 3.
  • 4.
  • 5.
  • 6. What is unique about the pharmaceutical industry? Clients/Partners Products/Services Employees/Managers
  • 7. Clients working together as CRO Partners Four C’s in CRO business CRO team members Key Performance Indicators (KPI)
  • 8.
  • 9.
  • 10.
  • 11. Products and services helping to reach drug sales goals 21 CFR Part 11 requirement Standard macros QC and delivery
  • 12.
  • 13.
  • 14.
  • 15. Employees and managers sharing a common vision Communication, Communication, Communication ‘ Sharpen the Saw’ Industry-Related Magazines One-on-one meetings
  • 16.
  • 17.
  • 18.
  • 19.
  • 20.
  • 21. Developing an effective training program Client Requirements Best Practices Corporate Ladder
  • 22. Training Program meets client’s requirements Client working environment Real-world programming tasks Monitor, evaluate and provide feedback
  • 23.
  • 24.
  • 25. Monitor, evaluate and provide feedback Minimum feedback and yearly monitoring Performance reviews Mentor by Director General feedback and monthly monitoring One-to-one meetings Mentor by Senior/Manager Detail feedback and close monitoring Daily or every other day Mentor by Senior/Manager Senior/Manager Junior Entry
  • 26. Monitor, evaluate and provide feedback Minimum feedback and yearly monitoring Performance reviews Mentor by Director General feedback and monthly monitoring One-to-one meetings Mentor by Senior/Manager Detail feedback and close monitoring Daily or every other day Mentor by Senior/Manager Senior/Manager Junior Entry
  • 27. Best Practices training program Continuous Improvement Train Feedback Update “ Plan, Do, Check, Act” , Deming Mastery of SAS Programming Understanding of Clinical Trials Data
  • 28.
  • 29.
  • 30. Climbing the corporate ladder Entry (< 2 yrs) Junior (2 – 5 yrs) Senior/ Manager (>= 5 yrs) Responsibilities Training
  • 31. Titles and general responsibilities need to be understood and applied - Critical Thinker - Efficacy Programming - Maintain Program Index excel file - Tools/Macro Development - Effective Delegator - Source Programming - Annotated Graphs - Macro Validation Programming - Opportunity for leadership roles - Validation Programming of simple listings - Edit Checks - Simple Data Listings Lead Programmer Statistical Programmer II Statistical Programmer I Senior/Manager Junior Entry
  • 32. Titles and general responsibilities need to be understood and applied - Critical Thinker - Efficacy Programming - Maintain Program Index excel file - Tools/Macro Development - Effective Delegator - Source Programming - Annotated Graphs - Macro Validation Programming - Opportunity for leadership roles - Validation Programming of simple listing - Edit Checks - Simple Data Listings Lead Programmer Statistical Programmer II Statistical Programmer I Senior/Manager Junior Entry
  • 33.
  • 34.
  • 35. Performing in the pharmaceutical industry Poor and Good Performance
  • 36. Red flags of poor performance Screen candidates for skills SAS programming skills need improvement Communication of clinical issues is poor
  • 37.
  • 38.
  • 39.
  • 40. Critical success factors of good performance Highly Motivated Employees Searches to understand the ‘why’ Becomes more productive with experience Follows trends for increased productivity
  • 41.
  • 42.
  • 43.
  • 44.
  • 45. In summary, challenges in the pharmaceutical industry can be overcome Effective Communication Early identification of Safety Issues Understanding Clinical Data Following FDA Requirements
  • 46. Through effective partnership, training and commitment, you are better prepared for the next level. http://www.freeimages.co.uk/
  • 47. Practice Makes Perfect: Training and Performing in the Pharmaceutical Industry Sunil Gupta [email_address] Quintiles

Notas do Editor

  1. Thanks : I would like to thank Rick for asking me to present on this topic. It is based on the new employee training program I developed for all SAS programmers and statisticians in our office. This presentation is focused on the manager from a CRO perspective. I have also written several papers on this subject. Engage : Please raise your hands if you are interested in getting into the pharmaceutical industry or are curious about what is unique about this industry. Poll: # entry, # people &lt; 5 yrs, # people &gt;= 5 yrs Confirm : Hope that you will find it rewarding feeling that you have contributed to saving patients or improving their lives, Health care, high impact Notice the term ‘ Practice ’, just like doctor’s office for practicing medicine – always strive for continuous improvement in everything you do to achieve center of excellence. Throughout my presentation, I will identify one topic that is the same with other industries (communication), and three topics that are special to the pharma industry. See if you can identify them. what is the difference (safety, requirements, clinical data )? Key words: Thanks (Section chair), Engage (Poll), Confirm (Audience), Annotate (Flow, Movement), Experience (Story/Names/Locations/Real, Lessons Learned), References/Facts/Stats (More info), Transition (Relationship, Sequence, Logic, Compare/Contrast/Analogy), Images (Title, Challenge, 3 Key Concepts (7 max), Visuals, Cartoons, Outcome), Mindmapping, Quote, Chart Overlay (Focus, Organize Concepts, Sequence Concepts, Process Flow, Relationships, Other)