GLP Toolkit

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Ensure best practices for research and Data integrity standards are integrated in Research and Development strategies; Maintain Quality Control and high standards throughout the lifecycle of each project, identifying areas of best practice and Process Improvement.

More Uses of the GLP Toolkit:

  • Oversee: constantly seek innovative ways to deliver better value to clients in a highly professional, profitable manner.

  • Communicate with sponsor regarding timing and tracking of incoming products, testing dates, and shipping requirements, etc.

  • Orchestrate: plan meetings and prepare agendas, facilitate Project Planning and Decision Making, prepare and/or locate necessary materials and resources, facilitate group process, and help develop Work Plans.

  • Provide feedback to Supervisor when a deviation from accepted practice or safety issue is recognized.

  • Take the lead in the development, communication, and maintenance of assigned systems, SOPs, Policies and Procedures.

  • Be accountable for ensuring that work product aligns with design and performance standards, regulatory environment and customer expectations.

  • Methodize: work closely with internal departments to ensure timely and proper delivery of product through your next app.

  • Be accountable for planning and execution of experiments and validation of protocols, provide technical direction and mentoring to Development Associates.

  • Provide support in technical transfer of processes to process development to manufacturing facilities.

  • Maintain contact with project Service Providers to ensure timely activity, integration, and efficient use of resources to meet project requirements.

  • Maintain inspection readiness through inspection preparedness program and periodic readiness verification.

  • Ensure your organization culture fosters innovation and Staff Development while appreciating individual contributors.

  • Maintain positive work atmosphere by behaving and communicating in a professional manner with coworkers, research staff, and managers.

  • Comply always with organization Standard Operating Procedures unless specifically varied in the validation or sample analysis plan.

  • Evaluate: specific technical skills as defined by management based on anticipated and approved projects in agreement with strategic organization goals and objectives.

  • Find practical and pragmatic solutions in your organization environment with strict regulatory control.

  • Be certain that your organization operates equipment and uses supplies according to safety guidelines; performs general housekeeping and adheres to safety procedures.

  • Warrant that your organization records data in compliance with organization and regulatory Policies And Standards to meet quality and accuracy requirements.

  • Meet with individuals or work groups to consider problems and issues identified on assigned projects.

  • Become committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.

  • Maintain contact with project stakeholders to ascertain level of satisfaction with progress and performance.

  • Maintain equipment and facilities in accordance with applicable SOPs and in a safe, clean, neat and organized manner.

  • Maintain, calibrate, and perform preventative maintenance of equipment to maintain efficient and safe operations.

  • Use logic to analyze or identify underlying principles, reasons, or facts associated with information or data to draw conclusions.

  • Ensure optimal Intellectual Property strategy is integrated into development and life cycle management programs to deliver long term value from product portfolio.

 

Save time, empower your teams and effectively upgrade your processes with access to this practical GLP Toolkit and guide. Address common challenges with best-practice templates, step-by-step Work Plans and maturity diagnostics for any GLP related project.

Download the Toolkit and in Three Steps you will be guided from idea to implementation results.

The Toolkit contains the following practical and powerful enablers with new and updated GLP specific requirements:


STEP 1: Get your bearings

Start with...

  • The latest quick edition of the GLP Self Assessment book in PDF containing 49 requirements to perform a quickscan, get an overview and share with stakeholders.

Organized in a Data Driven improvement cycle RDMAICS (Recognize, Define, Measure, Analyze, Improve, Control and Sustain), check the…

  • Example pre-filled Self-Assessment Excel Dashboard to get familiar with results generation

Then find your goals...


STEP 2: Set concrete goals, tasks, dates and numbers you can track

Featuring 991 new and updated case-based questions, organized into seven core areas of Process Design, this Self-Assessment will help you identify areas in which GLP improvements can be made.

Examples; 10 of the 991 standard requirements:

  1. Are handling conditions specific to the test substance clearly identified, as temperature conditions or length of storage time before reversion of transformation?

  2. What different stages does a drug go through from the moment when its under the lenses of a microscope in a lab, to the time it reaches the consumers?

  3. Does the Quality Control organization use all Test Methods which are necessary to confirm that the product complies with the acceptance criteria?

  4. What barriers on organizational, organizational and technical level occurred when implementing the initiative and how was dealt with barriers?

  5. Does the protocol specify the method of application/route of administration of the test substance and the reason for its selection?

  6. Are your organization and production measuring instruments that are important for the quality of the product calibrated regularly?

  7. Are your organization and testing facilities appropriate for work with infectious agents or potentially infectious materials?

  8. Is the Quality Control organization responsible for sampling, controls and releases according to defined acceptance criteria?

  9. How to fulfill Regulatory Requirements while making the best use of your common sense, knowledge, talents, and resources?

  10. How will the care offered in it benefit by introduction of testing or the addition of a new test, and what will it cost?


Complete the self assessment, on your own or with a team in a workshop setting. Use the workbook together with the self assessment requirements spreadsheet:

  • The workbook is the latest in-depth complete edition of the GLP book in PDF containing 991 requirements, which criteria correspond to the criteria in...

Your GLP self-assessment dashboard which gives you your dynamically prioritized projects-ready tool and shows your organization exactly what to do next:

  • The Self-Assessment Excel Dashboard; with the GLP Self-Assessment and Scorecard you will develop a clear picture of which GLP areas need attention, which requirements you should focus on and who will be responsible for them:

    • Shows your organization instant insight in areas for improvement: Auto generates reports, radar chart for maturity assessment, insights per process and participant and bespoke, ready to use, RACI Matrix
    • Gives you a professional Dashboard to guide and perform a thorough GLP Self-Assessment
    • Is secure: Ensures offline Data Protection of your Self-Assessment results
    • Dynamically prioritized projects-ready RACI Matrix shows your organization exactly what to do next:

 

STEP 3: Implement, Track, follow up and revise strategy

The outcomes of STEP 2, the self assessment, are the inputs for STEP 3; Start and manage GLP projects with the 62 implementation resources:

  • 62 step-by-step GLP Project Management Form Templates covering over 1500 GLP project requirements and success criteria:

Examples; 10 of the check box criteria:

  1. Human Resource Management Plan: Are changes in scope (deliverable commitments) agreed to by all affected groups & individuals?

  2. Human Resource Management Plan: Is there an on-going process in place to monitor GLP project risks?

  3. Schedule Management Plan: Are all payments made according to the contract(s)?

  4. Scope Management Plan: Does a documented GLP project organizational policy & plan (i.e. governance model) exist?

  5. Project Scope Statement: Has the format for tracking and monitoring schedules and costs been defined?

  6. Procurement Audit: Are the established budget and timetable (milestones) respected?

  7. Project Performance Report: To what degree are the skill areas critical to team performance present?

  8. Activity Duration Estimates: Based on , if you need to shorten the duration of the GLP project, what activity would you try to shorten?

  9. Project Management Plan: Is the engineering content at a feasibility level-of-detail, and is it sufficiently complete, to provide an adequate basis for the baseline cost estimate?

  10. Lessons Learned: Was any formal risk assessment carried out at the start of the GLP project, and was this followed up during the GLP project?

 
Step-by-step and complete GLP Project Management Forms and Templates including check box criteria and templates.

1.0 Initiating Process Group:


2.0 Planning Process Group:


3.0 Executing Process Group:

  • 3.1 Team Member Status Report
  • 3.2 Change Request
  • 3.3 Change Log
  • 3.4 Decision Log
  • 3.5 Quality Audit
  • 3.6 Team Directory
  • 3.7 Team Operating Agreement
  • 3.8 Team Performance Assessment
  • 3.9 Team Member Performance Assessment
  • 3.10 Issue Log


4.0 Monitoring and Controlling Process Group:

  • 4.1 GLP project Performance Report
  • 4.2 Variance Analysis
  • 4.3 Earned Value Status
  • 4.4 Risk Audit
  • 4.5 Contractor Status Report
  • 4.6 Formal Acceptance


5.0 Closing Process Group:

  • 5.1 Procurement Audit
  • 5.2 Contract Close-Out
  • 5.3 GLP project or Phase Close-Out
  • 5.4 Lessons Learned

 

Results

With this Three Step process you will have all the tools you need for any GLP project with this in-depth GLP Toolkit.

In using the Toolkit you will be better able to:

  • Diagnose GLP projects, initiatives, organizations, businesses and processes using accepted diagnostic standards and practices
  • Implement evidence-based best practice strategies aligned with overall goals
  • Integrate recent advances in GLP and put Process Design strategies into practice according to best practice guidelines

Defining, designing, creating, and implementing a process to solve a business challenge or meet a business objective is the most valuable role; In EVERY company, organization and department.

Unless you are talking a one-time, single-use project within a business, there should be a process. Whether that process is managed and implemented by humans, AI, or a combination of the two, it needs to be designed by someone with a complex enough perspective to ask the right questions. Someone capable of asking the right questions and step back and say, 'What are we really trying to accomplish here? And is there a different way to look at it?'

This Toolkit empowers people to do just that - whether their title is entrepreneur, manager, consultant, (Vice-)President, CxO etc... - they are the people who rule the future. They are the person who asks the right questions to make GLP investments work better.

This GLP All-Inclusive Toolkit enables You to be that person.

 

Includes lifetime updates

Every self assessment comes with Lifetime Updates and Lifetime Free Updated Books. Lifetime Updates is an industry-first feature which allows you to receive verified self assessment updates, ensuring you always have the most accurate information at your fingertips.