1. Empowering Operations and Perfecting ComplianceTechnical Knowledge Management

2. Bespoken Instructions 3. Learning pathway Knowledge definition* The psychological result of perception, learning and reasoning Something you have observed That you have interpreted and stored That you can apply to future situations*Webster 4. How we work Storyboard Transfer the full actual instructions into a synopsis of operations Customer project team approval Capture Video capture on-site Selection of key steps Project Organize the procedure relevant information Project Mediabooks Libraries Released Mediabooks SOPs, Specimens, Warnings & Symbols Publishing Simplifying update and revision exercise 5. Agenda 1.Single Use Ecosystem2.Shop floor Set Up & Operations3.Compliance4.Case Study5.Lessons Learnt and Conclusion 6. Single Use Last Decade JourneyApplication focussed 7. Supply chain and packaging expertiseLeachables Extractables 8. Single Use Last Decade JourneySingle Use in production are pre-fabricated Units 9. On-The-Job: Successful model IKEA could never achieve such a lowcost position if customers did not agree to take on some of the tasks usually performed by manufacturers and retailers, such as delivering furniture to their homes and assembling it.Jrme Barthlemy: (Excerpts) FALL 2006 MIT SLOAN MANAGEMENT REVIEWSingle Use is changing personnel daily life 10. Instructions at point-of-useYet know-how and knowledge do not fully stand out from SOPs 11. Agenda 1.Single Use Ecosystem2.Shop floor Set Up & Operations3.Compliance4.Case Study5.Lessons Learnt and Conclusion 12. Set up a 50L BioreactorS.U versus 50L Bio preparation S.S 13. 50L Bio Single Use - courtesy of Crucell B.V. 14. CIP - SIP50L Bio Stainless Steel 15. Benchmark activities with Mediabooks Single Use activities Stainless Steel Deliver at point of use, Gaskets/ Seals Unpacking and check Valves & Air Filters connections Installation Sensors Inflation SIP CIP Sensors and fluids connections Run Run 16. Single-UseStainless Steel1000L Bioreators Set up comparison time wise Courtesy of Sartorius Stedim biotech 17. The Last Mile: Activities ChangedSkill Sets ChangedLogistic ChangedRisks ChangedLabor more complexSuccessfull Single Use implementation requires to cope with a Shopfloor ECOSYSTEM change 18. Agenda 1.Single Use Ecosystem2.Shop floor Set Up & Operations3.Compliance4.Case Study5.Lessons Learnt and Conclusion 19. Compliance CDER Enforcement Actions Top 20 483s FY 2012 44% SOP related 11% Training related 1200 1000 275 800258237286 228258 239600Biologics400 649572498200720082005947467587872010201120120 200620092006 2012 : number of 483s issuedDrugs 20. Top 20 Inspectional Observations Training related 483 citations :DRUGS FY 2006 2007 2008 2009 2010 2011 2012 2012 DRUGS FY 2006 483 FY citations analysis rank freq rank freq rank freq rank freq rank freq rank rank Freq freq Freq 483 FY citations analysis rank freq Training-operations, GMPs, written procedures21 CFR 211.25(a) 8 59.00 65.00 8 21 60.008 79.00 5 92.00 8 65.00 Training-operations, GMPs, written procedures 9 60.00CFR 211.25(a) 8 48.00 109 49.00 GMP Training Frequency 21 CFR 211.25(a) 23 38.00CFR18 41.00 24 27.00 27 31.00 16 48.00 18 49.00 13 54.00 54.00 21 211.25(a) 13 23 38.00 GMP Training Frequency Training, Education, Experience overall 21 CFR 211.25(a) 62 16.00CFR48 19.00 108 8.00 31 27.00 20 44.00 25 38.00 19 44.00 44.00 19 21 211.25(a) 62 16.00 Training, Education, Experience overall 97 21 108 8.00 77 13.00 Supervisor Training/Education/Experience Supervisor Training/Education/Experience 21 CFR 211.25(b) 77 13.00CFR 211.25(b)118 5.00 124 6.00 81 12.00 76 14.00 97 9.00 9.00 60.00 60.00 100.00 48.00 49.00 171.00 141.00163.00 163.00 # # Total Training top 20 Total Training citations citations top 20 4.75% 11.52% versus citations top 20 versus sum sum citations top 20 4.75% 8.22% 4.97% 3.93% 8.73%11.31% 11.31% it Procedures not in writing, fully followed 21 CFR 211.22(d) 1 127.00 1 150.00 1 112.00 1 157.00 1 165.00 1 201.00 1 169.00 Absence of Three citations are now in the top 20 7showing improvement6is89.00 Written Procedures 21 CFR 211.100(a) 5 83.00 62.00 7 52.00 6 75.00 2 128.00 required 3 116.00 Written procedures not established/followed 21 CFR 211.67(b) translate 10 52.00 43.00 9 64.00 80.00 How to ensure the training 10 54.00 into less9 deviation and 7more 7 89.00 7 73.00 SOPs not followed / documented 21 CFR 6 82.00 5 72.00 5 58.00 4 81.00 2 115.00 6 89.00 10 64.00 efficient processes? 211.100(b) 346.00 336.00 265.00 377.00 449.00 507.00 422.00 # Total SOPs out of top 10 citations Retrain is not doing better 42.51% 43.75% 43.09% 45.53% 46.72% 46.99% 44.70% FDA White Paper: March 2011 citations How To Reduce Human Error By Managing Human Factors White Paper TOP 10 814 768 615 828 961 1079 944.00 Top 20126412169661247148516161441 21. Top 10 Inspectional Observations SOP related 483 citations 2006 Procedures not in 21 CFR 211.22(d) Responsibilities of 1 127 writing/ fully followed quality control unit Absence of Written Production and 21 CFR 211.100(a) 5 83 Process Controls Procedures Written procedures 21 CFR 211.67(b) Cleaning and not established/ 10 54 Maintenance followed Production and SOPs not followed / 21 CFR 211.100(b) 6 82 Process Controls documented 346 # Total SOPs related out of top 10 citations 42.51% 20072008200920102011201211501112115711651201 1 1697627526756892128 3 11610529439647807895725584812115689 10 64336 43.75%265 43.09%377 45.53%449 46.72%SOPs: can they kill 2 birds ..Documentation and Training? Yet the instruction is of essence and must be documented.How to ensure the instructions pertained in SOPs are fully understood and performed on a daily basis? Augment ownership of operations?507 46.99%773422 44.70% 22. Agenda 1.Single Use Ecosystem2.Shop floor Set Up & Operations3.Compliance4.Case Study5.Lessons Learnt and Conclusion 23. Minimizing variability in process operations using knowledge management platform Herman van Herk Scientist USP Vaccine Process and Analytical Development Archimedesweg 4-6 PO Box 2048 2301 CA Leiden The Netherlands Tel: +31 (0)71 519 9197 Email: hvanher@its.jnj.com 24. Agenda 1.Single Use Ecosystem2.Shop floor Set Up & Operations3.Compliance4.Case Study5.Lessons Learnt and Conclusion 25. Lessons Learnt and Questions 1. SOPs : Must be followed Sole training material? 2. Classrooms Hands-on Training efficacy? Lectures or Visual 3. Resources: Experts / Trainers availability Mentoring & Learn-by-peers On-the-Job 26. Manage Technical Assets differentlyFlip the class room Back to the roots 27. The Edtech experience illustrationhttp://youtu.be/gM95HHI4gLk?t=5m40sSalman Khans Talk at TED.com (excerpts) 28. Conclusion Compliance & Cost control First Hand Reference Tutorials Efficient documentation process Less deviationsExpandableCoordination Irrespective of language Watch it and do itEmpower Personnel: Move from certainty to routine dexterity 29. Thank youExpandable and language free