Bill Clark
Manager , Seattle Facilities & Engineering
Space Planning, BMRAM System Owner
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84-90
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92-95
95-98
98-99
99-02
02-05
05-07
07-09
09-10
10-Pres
Reactor Operator
– U.S. Navy
Instrument Technician
– Immunex
Validation Technician
– Immunex
Supervisor, Validation
– Immunex
Manager, Eng. Services
– Immunex
Manager, GMP/R&D Maintenance – Immunex
Manager, Maintenance & Utilities – Immunex
Area Manager, Maint. & Cal’n
– Amgen
Maint. & Utilities Specialist
– Amgen
Maint. Mgmt. Sys. Lead
– Snohomish Co PW
Facilities Manager
– Acucela
Manager, Facilities & Engineering – Dendreon
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Edgar Engleman and Samuel Strober
Founded Activated Cell Therapy in 1992 in
Mountain View, CA
1995 Name changed to Dendreon and moved
to Seattle
2000 Started up R2 BMRAM in Seattle
Provenge data presented April 2009
April 29, 2010, PROVENGE® received FDA
approval
Oct. 2012 R3 for non GMP
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Driven by Validation Dept. 2000
 F&E created in 2006-7
 Priority given to having a regulated compliant
location of documents
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Focus was on the GMP equipment.
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Enrollment (Induction)
Validation
Calibration
Maintenance
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Seattle, WA
Morris Plains, NJ
One team
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Travel from site to site
All paper process
All hands effort at the site level to record on paper
Corporate team entered the data
▪ Calibration
▪ Maintenance
▪ Validation
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With the burden of a manual process and the
timeframe given only critical information was entered
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SOP’s
 Written to have flexibility
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WO’s
 Paper
 Electronic
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Work request
 Use BMRAM
 Use email and create WO
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Post approval of Provenge
 Rapid growth to meet high expectations
▪ From 200 to 1200+ employees in ~12 months
 Facilities & Engineering joins Dendreon in 2006-7
▪ 4 sites by the end of 2011
▪ Seattle HQ and R&D
 Facilities Management
▪ Morris Plains, NJ Manufacturing Plant
 Facilities & Engineering
▪ Seal Beach, CA Manufacturing Plant
 Engineering & Metrology
▪ Union City, GA Manufacturing Plant
 Engineering & Metrology
 Similar processes, but not identical
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Multi sites
 Individual flavors
▪ Similar processes are not consistent
▪ Sharing of best practices cannot be implemented
 Efficiencies not realized across all sites
 Central oversight/mandate
 Bringing all our experience together
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GMP Calibrations and Maintenance
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Calibration and Maintenance of QC equipment
Calibration and Maintenance of Manufacturing
Maintenance of Utilities
UC has started parts inventory and is mostly
paperless
 Validation
▪ CSV
▪ IOQ
▪ Requalification
 30 users license
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Manual data entry is not the way to go
Leverage technology
 Hardware
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Keep current with your software
 Work arounds are often addressed with the next
HF, SR, or Revision. R3
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Objective: One time data entry
 Eliminates duplicate effort
 Reduces errors by transcription
 Promotes sharing of information
 Increases data integrity
Without recognition
 No release management from IT
 Part time support from IT
 Upgrades compete with Enterprise Systems
▪ Payroll
▪ Quality Systems
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Document management
Training
Change Control
ER’s, CAPA tracking and approval
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Driven by the business
Standardize
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Calibrations
Maintenance
Global service contracts
Like for Like spare parts
Site specific
▪ Vendors
▪ Regional driven maintenance
▪ Weather
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Good Engineering/Maintenance practices
 Scheduled PM’s and Cals
 Documentation
▪ Work plans
▪ Calibration (MDT’s)
 Second check work out of the ordinary
 Established roles and approvals
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QA oversight (an added process for GMP)
 Validation
 QA review and approval (Quality by Design)
▪ Review where it adds value
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Foundation are the work rules
 Reviewed and approved up front
 Auditable by Quality Assurance 24/7
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Focused on value added review of daily work
 If a work plan or calibration is completed as planned,
no QA post review of the work is required.
 All On-Demand WO’s are reviewed
▪ Except – restock it’s such as light bulb replacements
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A base level of competency in our staff is
required
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Budget constraints
Competing priorities
 Business Case
▪ Dependent on historic data to show improvement
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A major benefit
 Everyone in F&E wants an easier way to track
Calibration and Maintenance
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Approved in earlier 2012 for non GMP work
Demonstrate improvements based on
lessons learned
Gain experience without the constraints of a
GMP environment
Test how our future GMP configuration would
look.
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All work (Calibration & Maintenance)
performed by F&E documented
One time data capture (document of record)
Parts tracked
SOP’s for who and why
Work plans/Events for what and when
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Thank you again for this opportunity
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