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Bill Clark Manager, Seattle Facilities & Engineering Space Planning, BMRAM System Owner.

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Presentation on theme: "Bill Clark Manager, Seattle Facilities & Engineering Space Planning, BMRAM System Owner."— Presentation transcript:

1 Bill Clark Manager, Seattle Facilities & Engineering Space Planning, BMRAM System Owner

2  84-90Reactor Operator – U.S. Navy  90-91Instrument Technician – Immunex  91-92Validation Technician – Immunex  92-95Supervisor, Validation – Immunex  95-98Manager, Eng. Services – Immunex  98-99Manager, GMP/R&D Maintenance – Immunex  99-02Manager, Maintenance & Utilities – Immunex  02-05Area Manager, Maint. & Cal’n – Amgen  05-07Maint. & Utilities Specialist– Amgen  07-09Maint. Mgmt. Sys. Lead – Snohomish Co PW  09-10Facilities Manager– Acucela  10-Pres Manager, Facilities & Engineering – Dendreon

3  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 R3 for non GMP

4  Driven by Validation Dept  F&E created in  Priority given to having a regulated compliant location of documents  Focus was on the GMP equipment.  Enrollment (Induction)  Validation  Calibration  Maintenance

5  Seattle, WA  Morris Plains, NJ  One team  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  With the burden of a manual process and the timeframe given only critical information was entered

6  SOP’s  Written to have flexibility  WO’s  Paper  Electronic  Work request  Use BMRAM  Use and create WO

7  Post approval of Provenge  Rapid growth to meet high expectations ▪ From 200 to employees in ~12 months  Facilities & Engineering joins Dendreon in ▪ 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

8  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

9  GMP Calibrations and Maintenance  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

10  Manual data entry is not the way to go  Leverage technology  Hardware  Keep current with your software  Work arounds are often addressed with the next HF, SR, or Revision. R3

11  Objective: One time data entry  Eliminates duplicate effort  Reduces errors by transcription  Promotes sharing of information  Increases data integrity

12 Without recognition  No release management from IT  Part time support from IT  Upgrades compete with Enterprise Systems ▪ Payroll ▪ Quality Systems ▪ Document management ▪ Training ▪ Change Control ▪ ER’s, CAPA tracking and approval

13  Driven by the business  Standardize ▪ Calibrations ▪ Maintenance ▪ Global service contracts ▪ Like for Like spare parts  Site specific ▪ Vendors ▪ Regional driven maintenance ▪ Weather

14  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  QA oversight (an added process for GMP)  Validation  QA review and approval (Quality by Design) ▪ Review where it adds value

15  Foundation are the work rules  Reviewed and approved up front  Auditable by Quality Assurance 24/7  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  A base level of competency in our staff is required

16  Budget constraints  Competing priorities  Business Case ▪ Dependent on historic data to show improvement  A major benefit  Everyone in F&E wants an easier way to track Calibration and Maintenance

17  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.

18  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  Thank you again for this opportunity

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