Project Management Tools Utilized in Tech Transfers

Morning Session #1Robert Beall, PMP

Introduction

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Robert Beall

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Transfer Experience Solids Transfer Engineer for Optimization in North America (OPINA) 132 Product transfersManaged Europe to USA NDA product transfers for 3 blockbuster product lines. Head of International transfers between Germany, US and India for WW distribution 18 productsHead of Life-Cycle product transfer for parenteral manufacturing 64 products.Solids Transfer Manager for animal Healthcare products – 32 productsMedical Device Transfer Consultant – 4 productsBiological product transfer leader – 4 products

Hometown: Syracuse, NYHome: Providence, RIFamily: Günther (Son), Maren (Daughter), Calvin (Son)Hobbies: Sailing, Travel, Olympic WeightliftingEducation: RIT BS - Engineering PMP

Agenda

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1) Initiation1) Governance2) The Charter

2) The Project Plan1) Communication Plan2) RACI3) Schedule4) Kick off

3) Monitoring 4) Controlling

1) Change orders2) Metrics3) Stage Gate Release

5) Closing

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Initiation Technical Transfer Charter

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Tools – Charter DocumentPurpose: 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

Technical Transfer CharterA3 Charter – Provides a graphic illustration of what needs to be done

4 Panel Charter

Technical Transfer Governance

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Governance

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

Transfer Manager Individual 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 Team Transfer 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.

Stakeholder Stakeholders 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

The Project PlanPlan Includes:

1) Scope from Charter2) Communication Plan3) Risk Management Plan4) RACI5) Schedule6) Monitoring & Controlling7) Change orders8) Metrics9) Stage Gate Release Closing

Xophilopham

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

The Project PlanRisk Management Risks based on scope of project Include mitigation plan as part of schedule

The Project PlanTools – RACI – Responsible, Accountable, Consulted, InformedAccountable - Ensures work is doneResponsible – Does the workConsulted - Provides Information, reviews work, participates in developmentInformed - Updated on progress, any impact.

The Work

The Team

Associated SOP

The Project PlanTools – The schedule - Align work and resources utilizing real work time with WBS - Identify resource overloads

The Project PlanTools – The schedule - Align work and time

- Utilize Network diagram

What are the resources doing?

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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

Kick off Meeting

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Kick off Meeting

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Transfer DashboardBuild with Project team

Weekly Dashboard 1) Project dates, Work complete2) Accomplishments3) Upcoming events4) Status of key areas5) Milestones

Share with Stakeholders

Monitoring

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Change order log

Change Orders1) List each change from agreed plan

Controlling

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Metrics

Controlling

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Stage Gates1) 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

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Lessons Learned1) 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

ReferencesISPE PDA TR65 2014 Technology Transfer

Questions