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OKR template to secure FDA approval for our new pharmaceutical product

public-lib · Published 6 months ago

Your OKR template

The main objective is to secure the FDA approval effectively for a new pharmaceutical product. The OKR highlights expeditious resolution of all FDA queries or issues related to the application within six weeks. This involves researching and compiling responses, submitting corrected responses, and identifying all FDA issues related to the application.

The objective envisions clear completion and compliant application submission to the FDA within the first month. It involves reviewing FDA guidelines for compliant application, complete application submission, and assembly of all necessary documents and data for application.

A substantial part of the strategy is to successfully pass the FDA inspection and audit of the production facilities. This necessitates maintaining accurate, updated, and accessible documentation and records. Training sessions on FDA regulations for all staff members and maintaining clean and safe facilities are strong initiatives in place.

This OKR is comprehensive in its approach, aiming to veer off potential mistakes or slippages at every step. Each initiative signifies proactive engagement rather than a reactive one, thereby ensuring a smoother approval process and the launch of the new pharmaceutical product.
  • ObjectiveObjectiveSecure FDA approval for our new pharmaceutical product
  • Key ResultKRResolve all FDA queries or issues regarding the application within six weeks
  • TaskResearch and compile thorough responses to each issue
  • TaskSubmit all responses and corrections to FDA within six weeks
  • TaskIdentify all FDA queries or issues on the application
  • Key ResultKRSubmit a complete and compliant application to FDA within the first month
  • TaskReview FDA guidelines to ensure application compliance
  • TaskSubmit the completed application to the FDA
  • TaskGather all necessary documents and data for application
  • Key ResultKRSuccessfully pass the FDA's inspection and audit of our production facilities
  • TaskEnsure all documentation and records are accurate, updated, and easily accessible
  • TaskProvide thorough training to staff on FDA regulations and requirements
  • TaskMaintain the facility's cleanliness and safety according to FDA standards
Use in Tability

How to edit and track OKRs with Tability

You'll probably want to edit the examples in this post, and Tability is the perfect tool for it.

Tability is an AI-powered platform that helps teams set better goals, monitor execution, and get help to achieve their objectives faster.

With Tability you can:

  • Use AI to draft a complete set of OKRs in seconds
  • Connect your OKRs and team goals to your project
  • Automate reporting with integrations and built-in dashboard

Instead of having to copy the content of the OKR examples in a doc or spreadsheet, you can use Tability’s magic importer to start using any of the examples in this page.

The import process can be done in seconds, allowing you to edit OKRs directly in a platform that knows how to manage and track goals.

Step 1. Sign up for a free Tability account

Go tohttps://tability.app/signup and create your account (it's free!)

Step 2. Create a plan

Follow the steps after your onboarding to create your first plan, you should get to a page that looks like the picture below.

Tability Import Options

Step 3. Use the magic importer

Click on Use magic import to open up the Magic Import modal.

Now, go back to the OKR examples, and click on Copy on the example that you’d like to use.

Copy from the template

Paste the content in the text import section. Don’t worry about the formatting, Tability’s AI will be able to parse it!

Importing from text

Now, just click on Import from text and let the magic happen.

Tability editor with imported content

Once your example is in the plan editor, you will be able to:

  • Edit the objectives, key results, and tasks
  • Click on the target 0 → 100% to set better target
  • Use the tips and the AI to refine your goals

Step 4. Publish your plan

Once you’re done editing, you can publish your plan to switch to the goal-tracking mode.

Publish import

From there you will have access to all the features that will help you and your team save hours with OKR reporting.

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