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Project Management Tools Utilized in Tech Transfers

Project Management Tools Utilized in Tech Transfers. Morning Session #1 Robert Beall, PMP. Introduction. Robert Beall. Hometown: Syracuse, NY Home: Providence, RI Family: Günther (Son ), Maren (Daughter ), Calvin (Son)

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Project Management Tools Utilized in Tech Transfers

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  1. Project Management Tools Utilized in Tech Transfers Morning Session #1 Robert Beall, PMP

  2. Introduction Robert Beall Hometown: Syracuse, NY Home: Providence, RI Family: Günther(Son), Maren (Daughter), Calvin (Son) Hobbies: Sailing, Travel, Olympic Weightlifting Education: RIT BS - Engineering PMP Transfer Experience Solids Transfer Engineer for Optimization in North America (OPINA) 132 Product transfers Managed Europe to USA NDA product transfers for 3 blockbuster product lines. Head of International transfers between Germany, US and India for WW distribution 18 products Head of Life-Cycle product transfer for parenteral manufacturing 64 products. Solids Transfer Manager for animal Healthcare products – 32 products Medical Device Transfer Consultant – 4 products Biological product transfer leader – 4 products Confidential 2

  3. Agenda • Initiation • Governance • The Charter • The Project Plan • Communication Plan • RACI • Schedule • Kick off • Monitoring • Controlling • Change orders • Metrics • Stage Gate Release • Closing Confidential 3

  4. Initiation Technical Transfer Charter • Tools – Charter Document • Purpose: The charter provides the boundaries of the project and insight into resources required, timing and cost. • Charter Contains: • Summary of goals • Milestone summary • List of changes by functional area • Scope - What is in and out of scope • Change risk assessment • Resource requirements by change • Team Members • Governance • Approved by: Sponsor, Team Leads, • Functional area Managers Confidential 4

  5. Technical Transfer Charter A3 Charter – Provides a graphic illustration of what needs to be done 4 Panel Charter

  6. Technical Transfer Governance • Spending within transfer budget • Shifting product transfer timing around within • project float • Adding or eliminating tasks on the project plan • Changing staffing on project team Above the waterline – make the decision on our own Governance Transfer Team Below the waterline – escalate to Sponsor • Decisions that could cause not meeting a Tech Transfer final project objective • Decision to delay or miss a regulatory commitment • Decision to eliminate a critical safety control • Decision to affect product safety, purity or efficacy • Communicating project updates external to site Confidential 6

  7. Technical Transfer Governance The Transfer Sponsor is a manager within the organization with demonstrable interest in the outcome of the transfer who is responsible for securing spending authority and resources for the transfer. Ideally, the Sponsor should be the highest-ranking manager possible, in proportion to the project size and scope. The transfer Sponsor initiates the transfer process, champions the transfer in the Organization, and is the ultimate decision-maker for the project. Sponsor

  8. The Project Plan • Plan Includes: • Scope from Charter • Communication Plan • Risk Management Plan • RACI • Schedule • Monitoring & Controlling • Change orders • Metrics • Stage Gate Release Closing Xophilopham

  9. The Project Plan Tools – Communication Plan - Who needs what information, when and how. - Who leads discussions

  10. The Project Plan • Risk Management • Risks based on scope of project • Include mitigation plan as part of schedule

  11. The Project Plan Tools – RACI – Responsible, Accountable, Consulted, Informed Accountable - Ensures work is done Responsible – Does the work Consulted - Provides Information, reviews work, participates in development Informed - Updated on progress, any impact. AssociatedSOP The Team The Work

  12. The Project Plan Tools – The schedule - Align work and resources utilizing real work time with WBS - Identify resource overloads

  13. The Project Plan Tools – The schedule - Align work and time - Utilize Network diagram

  14. What are the resources doing? Utilizing MS project correctly allows team to identify where money is spent. • Is the value worth the cost? • In this example: • Greater than 50% of money is spent on GMP documentation (Industry standard is 17%) • Engineering and Operations work is not defined enough. • Refine processes / deliverables to match value

  15. Kick off Meeting

  16. Kick off Meeting

  17. Monitoring Build with Project team Weekly Dashboard Project dates, Work complete Accomplishments Upcoming events Status of key areas Milestones Share with Stakeholders Transfer Dashboard

  18. Controlling Change Orders List each change from agreed plan Change order log

  19. Controlling Metrics

  20. Controlling Stage Gates Identify logical gates to ensure transfer occurs in appropriate sequence. Gates may occur in parallel. Create checks to confirm the work was done. - May have QA sign off if required.

  21. Closing Lessons Learned Gather team together and review each of the deliverables against charter. Confirm complete. Review what was good, and what needs improvement Write up.

  22. References ISPE PDA TR65 2014 Technology Transfer

  23. Questions

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