Project Management

Managing Pharmaceutical Manufacturing Projects and Process Validation

Move pharmaceutical manufacturing projects from general awareness to a repeatable, reviewable practice.

  • 5training days
  • 4modules
  • 8sessions
  • 32topics
View packages and pricesCourse outline
Managing Pharmaceutical Manufacturing Projects and Process Validation
5days

About the programme

Course Overview

Stakeholders withdraw support for pharmaceutical manufacturing projects quietly before they withdraw it formally. A schedule for the wider project and portfolio delivery agenda without a critical path is a wish list with dates. It concentrates on the parts of this strand of project and portfolio delivery that determine outcomes and treats the rest proportionately. Mature organisations treat pharmaceutical manufacturing projects as a standing capability rather than a project that finishes. Participants apply this aspect of project and portfolio delivery to their own project throughout, so the output is directly usable. The outcome is a practitioner who can hold a position on this area of project and portfolio delivery and revise it on evidence. It is pitched for practitioners with responsibility for pharmaceutical manufacturing projects, not for observers of it. What blocks progress on this part of project and portfolio delivery is usually unclear ownership rather than unclear intent. The programme closes with an action plan for the project and portfolio delivery discipline that each participant writes for their own organisation.

Expected Learning Outcomes

  • Recover pharmaceutical manufacturing projects when it is behind, without pretending it is not.

  • Design the governance and decision rights for pharmaceutical manufacturing projects.

  • Reduce avoidable variation in how pharmaceutical manufacturing projects is carried out across teams.

  • Define the scope of pharmaceutical manufacturing projects precisely, including what is explicitly excluded.

  • Build the reporting on pharmaceutical manufacturing projects that gives early warning rather than reassurance.

  • Anticipate the objections that pharmaceutical manufacturing projects will attract internally and answer them in advance.

  • Define the scope and boundaries of pharmaceutical manufacturing projects so that responsibility for it is unambiguous.

Who Should Attend

  • Staff seconded into improvement work on pharmaceutical manufacturing projects.

  • Risk managers supporting pharmaceutical manufacturing projects.

  • Team members preparing to take on project responsibility for pharmaceutical manufacturing projects.

  • Experienced practitioners formalising an approach to pharmaceutical manufacturing projects that has grown up informally.

  • Programme and portfolio managers overseeing pharmaceutical manufacturing projects.

  • Technical leads delivering work packages within pharmaceutical manufacturing projects.

Course Modules

Open any module to see its sessions and topics.

01

Pharmaceutical manufacturing projects: stakeholders, communication and support

2 sessions · 8 points

Session 1Closing out pharmaceutical manufacturing projects and capturing what was learned

  • Record what was learned when pharmaceutical manufacturing projects did not go as planned.
  • Archive the decision record for pharmaceutical manufacturing projects so successors understand it.
  • Manage supplier performance on pharmaceutical manufacturing projects against contract, not goodwill.
  • Collect evidence on the present handling of pharmaceutical manufacturing projects before proposing changes.

Session 2What has to be agreed before work on pharmaceutical manufacturing projects starts

  • Define how the benefit from pharmaceutical manufacturing projects will be measured after closure.
  • Compare resource demand from pharmaceutical manufacturing projects against other commitments.
  • Register the risks to pharmaceutical manufacturing projects with owner, probability and impact.
  • Set escalation thresholds for pharmaceutical manufacturing projects that work out of hours.
02

Pharmaceutical manufacturing projects: governance, gates and decision rights

2 sessions · 8 points

Session 1The decisions in pharmaceutical manufacturing projects that cannot be delegated

  • Define the decision gates for pharmaceutical manufacturing projects and what evidence each requires.
  • Write the scope statement for pharmaceutical manufacturing projects including explicit exclusions.
  • Prepare the summary of pharmaceutical manufacturing projects that senior management will read.
  • Set out the decisions in pharmaceutical manufacturing projects that require sign-off and by whom.

Session 2Managing suppliers delivering part of pharmaceutical manufacturing projects

  • Measure progress on pharmaceutical manufacturing projects by value earned, not tasks ticked.
  • Build reporting on pharmaceutical manufacturing projects that surfaces problems while they are small.
  • Identify where judgement in pharmaceutical manufacturing projects is legitimate and where it is not.
  • Review at each gate whether pharmaceutical manufacturing projects should continue at all.
03

Pharmaceutical manufacturing projects: progress measurement and early warning

2 sessions · 8 points

Session 1Estimating pharmaceutical manufacturing projects without anchoring on the answer wanted

  • Agree the smallest change to pharmaceutical manufacturing projects that would be visibly useful.
  • Build the competence framework that supports pharmaceutical manufacturing projects.
  • Map stakeholders of pharmaceutical manufacturing projects by influence and current level of support.
  • Hold a lessons session on pharmaceutical manufacturing projects while memory is accurate.

Session 2Measuring progress on pharmaceutical manufacturing projects honestly

  • Set out how exceptions to pharmaceutical manufacturing projects are requested and approved.
  • Establish what evidence demonstrates pharmaceutical manufacturing projects is under control.
  • Test the procedure for pharmaceutical manufacturing projects against a realistic scenario.
  • Reduce the variation in how pharmaceutical manufacturing projects is carried out between teams.
04

Pharmaceutical manufacturing projects: estimating cost and effort

2 sessions · 8 points

Session 1Building a schedule for pharmaceutical manufacturing projects with a real critical path

  • Agree what will be standardised in pharmaceutical manufacturing projects and what will not.
  • Check that records of pharmaceutical manufacturing projects answer the questions likely to be asked.
  • Identify the critical path through pharmaceutical manufacturing projects and the float elsewhere.
  • Define acceptance criteria for each deliverable of pharmaceutical manufacturing projects.

Session 2Handing over pharmaceutical manufacturing projects and proving the benefit

  • Agree the escalation threshold for pharmaceutical manufacturing projects in advance.
  • Plan handover of pharmaceutical manufacturing projects to the team that will operate it.
  • Confirm that reporting on pharmaceutical manufacturing projects reaches the people who can act.
  • Define the trigger that would require pharmaceutical manufacturing projects to be redesigned.

Choose the package that suits you

Silver Package

At least 3 people

USD1,250
  • Workshop or Program Participation
  • Airport Transfers
  • Customized Badge
  • Expert Mentorship (Private Sessions)
  • Supervision & Secretarial Services
  • Accredited Certificate of Participation
  • Complete Training Kit
  • Coffee Break
  • Closing Ceremony

Gold Package

At least 3 people

USD1,850
  • 5-night stay in a 5-star hotel
  • Workshop or Program Participation
  • Airport Transfers
  • Customized Badge
  • Expert Mentorship (Private Sessions)
  • Supervision & Secretarial Services
  • Accredited Certificate of Participation
  • Complete Training Kit
  • Coffee Break
  • Closing Ceremony

Complete your registration

We will contact you within one business day to confirm.

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