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

2. Introduction 2Confidential Robert Beall 2 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 Hometown: Syracuse, NY Home: Providence, RI Family: Günther (Son), Maren (Daughter), Calvin (Son) Hobbies: Sailing, Travel, Olympic Weightlifting Education: RIT BS - Engineering PMP

3. Agenda 3Confidential 1)Initiation 1)Governance 2)The Charter 2)The Project Plan 1)Communication Plan 2)RACI 3)Schedule 4)Kick off 3)Monitoring 4)Controlling 1)Change orders 2)Metrics 3)Stage Gate Release 5)Closing 3

4. Initiation Technical Transfer Charter 4Confidential 4 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

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

6. Technical Transfer Governance 6Confidential 6 6 Governanc e Transfer Team 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 Below the waterline – escalate to Sponsor Above the waterline – make the decision on our own 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

7. Transfer ManagerIndividual who has been assigned overall responsibility for the success of a project. This includes success in terms of cost, scope, schedule, and quality. The Transfer Manager is the person who is responsible for ensuring that the Project Team completes the project. The Transfer Manager develops the Transfer Plan with the team and manages the team’s performance of project tasks. It is also the responsibility of the Transfer Manager to secure acceptance and approval of the Transfer Plan from the Transfer Sponsors and Stakeholders. Transfer TeamTransfer Team Members are responsible for executing tasks and producing deliverables as outlined in the Transfer Plan and directed by the Transfer Manager, at whatever level of effort or participation has been defined for them. On larger transfers, some Transfer Team members may serve as Team Leaders, providing task and technical leadership. StakeholderStakeholders include all the people that are in any way affected by the transfer within the Client Organization. This may include the Transfer Team, the Site Management, Users, Reviewers and Approvers. 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 Technical Transfer Governance

8. The Project Plan Plan Includes: 1)Scope from Charter 2)Communication Plan 3)Risk Management Plan 4)RACI 5)Schedule 6)Monitoring & Controlling 7)Change orders 8)Metrics 9)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. The Work The Team Associated SOP

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? 14 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 15

16. Kick off Meeting 16

17. 17 Transfer Dashboard Build with Project team Weekly Dashboard 1)Project dates, Work complete 2)Accomplishments 3)Upcoming events 4)Status of key areas 5)Milestones Share with Stakeholders Monitoring

18. 18 Change order log Change Orders 1)List each change from agreed plan Controlling

19. 19 Metrics Controlling

20. 20 Stage Gates 1)Identify logical gates to ensure transfer occurs in appropriate sequence. 2)Gates may occur in parallel. 3)Create checks to confirm the work was done. - May have QA sign off if required. Controlling

21. 21 Lessons Learned 1)Gather team together and review each of the deliverables against charter. Confirm complete. 2)Review what was good, and what needs improvement 3)Write up. Closing

22. References ISPE PDA TR65 2014 Technology Transfer

23. Questions