sourcin tech transfert 2014
DESCRIPTION
Sourcin Tech Transfer presentation at Durham, UK May 15 2014TRANSCRIPT
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• Incorporated in 2011 Fribourg Switzerland
• Market: Operating Instructions – Production
• Sectors Biopharma, Medtech
• Unique blend of expertise
• Engineering
• Multimedia,
• Web portal
• Video
High Value Product Technology Transfer Conference 2014 Durham, UKMay 15 2014
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Agenda• Technologies Transfer
– Definition
– Review of experiences
• Examples of Actual Technologies to Transfer
• Learn from Existing Inspections Track Records
• Assist Knowledge Transfer
• Case study
• Support Tech Transfer Till Handover
• Conclusion
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What is Technology Transfer?¹
• Transfer of Technology (TOT), is the process of transferring skills,
knowledge, technologies, methods of manufacturing, samples of
manufacturing and facilities …..It is closely related to (and may
arguably be considered a subset of) knowledge transfer.
Horizontal Transfer is the movement of technologies from one area
to another.
• Transfer of Technology (TOT) is primarily horizontal. Vertical
Transfer is when technologies are moved from applied research
centers to research and development departments.
[1] Excerpts from http://en.wikipedia.org/wiki/Technology_transfer
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Speaking by experience
• Relevant Findings: “…Over 90% of vaccines are produced by less than 15 manufacturers, and over 80% of vaccines are produced in LMICs (compared with only 7% of drugs).” - Dr. Wenfeng Gong -
• NVI (Nederland Vaccin Instituut) high requirement for technical know-how :– Production, – Quality Control, – QA Regulatory
• referring to Amie Batson and Julie B. Milstien - Health Affairs 27, no. 1 (2008): 140–142; 10.1377/ hlthaff.27.1.140
• Jean-Marie Préaud JAPANESE ENCEPHALITIS project :“Capacity building” in China. “…It takes a long time for training and implementing Quality Management Systems…”
– Language barrier leading to misinterpretation of documents.– Training have to be repeated to make sure that lessons are understood correctly.
• Michel BAIJOT: FIOCRUZ – GSK: – Develop people by training and empowerment– Learning by doing and the learning curve: The recipient of technology must adapt a “do-it “ attitude
• Jean-Marie Préaud: Development of MenAfriVac™ in IndiaAn example of efficient technology transfer to develop a needed vaccine– communication was the key to the success of this project
Workshop on Technology Transfer WHO HQ – Geneva, November 30th – December 1st, 2010. http://www.who.int/phi/news/workshop_tt_vaccines2010/en/
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Considerations
• Technologies to Transfer
– Production,
– Quality Control,
– QA Regulatory
• Expertise implies
– Versatile Activities
– Broad Skill Sets
– Logistic
• Intensive Training activities
– Language Barrier
– Learning by doing
• Costs
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Bioproduction Models1/3
Single Use in production are pre-fabricated Units
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Set up of a 50L Bioreactor Single Use
Bioproduction Models2/3
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CIP - SIP
50L Bio Stainless Steel
Bioproduction Models3/3
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Regulatory Inspections
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Inspectional Observations CDERCitations review
«Retrain is not doing better»
FDA White Paper: March 2011
How To Reduce Human Error By Managing Human Factors White Paper
2006 2007 2008 2009 2010 2011 2012 2013-2%
0%
2%
4%
6%
8%
10%
12%
14%
16%
0%
5%
10%
15%
20%
25%
30%
35%
Top 20: Training related
enforcements
Top 10: SOP related
enforcements
21 CFR 211.25(a) &(b)Personnel qualifications
21 CFR 211.100(a)&(b)Production and Process Controls21 CFR 211.67(b)Cleaning and Maintenance
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Metrics?
Measuring Training Effectiveness
• Ensure training translate into less deviation and more efficient
processes (performance)
Improving SOP and Policy Management
• Ensure the instructions pertained in SOPs are fully understood
and performed on a daily basis?
By Asking ourselves:
• Was the procedure adequate and able to be followed?
• Did training prepare the person to perform the task?
• Was Operating procedures Aligned to the Shop-floor
Human Error Is The Leading Cause Of GMP Deviations – Or Is It?Joanna Gallant
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Empowering Operations and Perfecting Compliance
Technical Knowledge Management
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Content preparation & diffusion
Operations: Mediabooks
• Prepare instructions
• Visual - Language Free
• Dedicated Reference
Organize Information: Diffusion
• Libraries:
Mediabooks, Documents, Forum & Quiz
• Collaborative environment
Secured connection, id, pw profiles
• On-The-Job, Training
• Share
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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
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How we work: Tandem w/ SME
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• Create Customer Platform• Organize the procedure relevant information• Deliver Draft Mediabooks
Libraries• Released Final Mediabooks• SOPs, Specimens, Warnings & Symbols Publishing• Simplifying update and revision exercise
NDA
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How is it used during a ToT ?
?Coordination
– Proactively “export” Tech context
– Leverage from the ToT stakeholders
– Ensure to capture adequate practical knowledge
– Build up a Repository of Knowledge
– Secure Start up Phase
Minimize Variability– On-the-job assistance
• Contribute to standardization
– Staff training management• Secure know-how in-house • Prevent skillsets loss
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New training model: “Flip the Classroom”
Assign «Lectures» as Homework:
Watch contextualized operations prior to hands-on sessionsi. Start, Pause, Replay, without fearing interrupting ii. Free up Expert time
Hands-on sessions
i. Efficient vs time and costsii. Minimize risk on production lines
Optimize skill sets
i. Mentoring, ii. Learn by peer
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Minimizing variability in process operations using knowledge management platform
Herman van HerkScientist USPVaccine Process and Analytical Development Archimedesweg 4-6PO Box 20482301 CA LeidenThe NetherlandsTel: +31 (0)71 519 9197Email: [email protected]
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Leiden-USP-Valerio
Bern-Cell & virus banking-USP-Process characterization
Solna
Springhouse
External-Licensees-Partners
Key elements:-Training-Standardized Operation
Knowledge transfer for USP processes
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Mediabooks platform
• Current platform:
7 applications with > 50 Mediabooks
Used across different sites within Crucell
Used for training of external parties as well
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Conclusion
• Mediabooks tools help to:• Share: Learn from each other and analyze• Show what cannot be written• Train by reviewing key steps at its own pace
For Crucell, it is a strong tool for both training and standardization of USP processes
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Support Tech Transfer till handover
1. Capitalize from the high concentration of
knowledge during the TOT project
2. Training: Classrooms – Hands-on
The devil is in the detail: catch it and share it!
3. Resources and time:
– Experts and project members availability
4. Ensure continuity in communication
– Mentoring & Learn-by-peers
– On-the-Job : routine dexterity
5. Back to the roots!
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Conclusion
Knowledge Transfer:
Reference Tutorials
Efficient, secured of mean documenting
process key operating features
Coordination
Fostering a seamless, contextual practical knowledge
Securing relevant skill sets in routine manufacturing
processes on the receiving end
Transferrable
Build your Thesaurus
Share it proactively
Plan training early
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Thank you
“Watch it and do it”
KNOWLEDGE BECOMES INFECTIOUS
Arnaud Schmutzwww.sourcin.com