All You Need to Know About Validation Project Management in 7 Steps.

what is validation project management


In this article, you will learn what is Validation Project Management (VPM) according to the FDA and cGMP Good Manufacturing Practices.

The objective is to produce a complete project which complies with the client’s or user’s objectives.

Sometimes, the objective of project management is also to shape or reform the client’s brief to feasibly address the client’s objectives. Once the client’s objectives are clearly established, they should influence all decisions made by other people involved in the project.

Indeed, it is defined as the practice of initiating, planning, executing, controlling, and closing the work of a team to achieve specific goals and meet specific success criteria at the specified time.

Validation Project Management processes fall into 7 groups or steps:

  1. Project Plans: An approved document used to guide both project execution, monitoring, and control.  It facilitates communication among project team members and stakeholders.  The project plan must contain a document approved scope, cost, and schedule baselines.
  2. Project Schedules: It indicates what needs to be made, which resources and materials must be utilized, and when the project must be finished. Moreover, the project schedule is a timetable that outlines start and end dates and milestones that must be met for the project to be due on time.  The project schedule must be updated on a regular basis in order to gain a better understanding of the project’s current status.
  3. Project Training: Teach the importance of time and setting goals and objectives. Prioritize the goals and assist in making the best use of the time.  Determine how to estimate the resources that will be needed in future project tasks and set realistic budgets.
  4. Project Coordination: Project coordination is the daily management of activities within a validation project. The main purpose of coordinating projects is to streamline the workflow of each task.
  5. Project Monitoring, Controlling, and Reporting: The Monitoring, Control, and Reporting of project tasks aim to prevent show stoppers and holding the execution so that potential problems can be identified in a timely manner and corrective action can be taken, when necessary, to control the execution of the project.
  6. Project Execution: Project execution is when everything has been planned is put into action.  Project execution means that the plan started and is rolling up taking action on everything outlined.
  7. Project Completion: One of the purposes of the project closure is to provide formal notice to the stakeholders, usually in written form, that the deliverables are acceptable and satisfactory or have been rejected. If the product or service does not meet the expectations, the responsible parties will need to correct the problems before issue a formal acceptance notice.

The primary challenge of project management is to achieve all of the project goals within the given constraints.

The primary constraints are scope, time, quality, and budget.

The second constraint is optimizing the allocation of necessary inputs and apply them to meet pre-defined objectives.

The most common software applications used in project management are Microsoft Project, Primavera, etc.

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CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. Rest assured of the safety or being in the right hands.

Our validation project team could provide you a broad range of professional expertise in:

  1. Project Plans
  2. Project Schedules
  3. Project Training
  4. Project Coordination
  5. Project Monitoring, Controlling, and Reporting
  6. Project Execution,
  7. Project Completion.


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Quality procedures templates

Three (3) Options to Create Document Control Management DCM Procedures:

Bronze Option. You Can Create Your Own Quality Procedures, using a Template.

You can download samples of the Document Control Management DCM procedure templates in .pdf format. 

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In addition, you can request a quotation to buy online a full SOP template document in MS Word format that is completely editable, ready to fill, and adapt to your specific needs.

Silver Option. We Can Bring You Formal Training about Validation Project Management.

This option is recommended if you want to learn more about how to build robust quality system procedures. One of our expert(s) can provide online step-by-step training to your team (unlimited assistance) on how to build reliable SOPs using our template(s). Also, you can improve your corporate quality procedures and policies by incorporating our template(s) and tools.  It includes a fully editable template from the Bronze option, plus training, exams, and a training certificate for each assistant.  Request a quote now.

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REFERENCES: Validation Project Management.



Picture of Ramon Cayuela, MS, BS, Chemical Engineering

Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!