Description

Record your built in control results

Does your organization have sample information readily available?

Are the testing personnel trained prior to performing organization testing?

...Find the answers to these, and more, questions with this Good Laboratory Practice Toolkit:

Calculate your uncertainty of measurement.
Handle for transport, store, use and maintain your measuring equipment.
Ensure that your personnel are competent.
Get to your suppliers to cooperate.
Record external quality control results.
Handle test, calibration, inspection/verification items.
Inspect items condition on receipt.
Make sure that corrective factors are applied after calibration.
Make sure that the results of the test/calibration are valid.

HOW THIS TOOLKIT WORKS:

Save time, empower your teams and effectively upgrade your processes with access to this practical Good Laboratory Practice Toolkit and guide. Address common challenges with best-practice templates, step-by-step work plans and maturity diagnostics for any Good Laboratory Practice 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 Good Laboratory Practice specific requirements:

STEP 1: Get your bearings

Start with...

The latest quick edition of the Good Laboratory Practice 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 997 new and updated case-based questions, organized into seven core areas of process design, this Self-Assessment will help you identify areas in which Good Laboratory Practice improvements can be made.

Examples; 10 of the 997 standard requirements:

Are handling conditions specific to the test substance clearly identified, as temperature conditions or length of storage time before reversion of transformation?
Does the quality control organization use all test methods which are necessary to confirm that the product complies with the acceptance criteria?
What barriers on organizational, organizational and technical level occurred when implementing the initiative and how was dealt with barriers?
Does the ds cgmp rule require quality control personnel to review and approve your organization control processes you establish and follow?
Are the types of waste defined for the work of the quality control organization which could affect the quality of the finished products?
Does the director ensure implementation of a safe laboratory environment in compliance with good practice and applicable regulations?
Does the protocol specify the method of application/route of administration of the test substance and the reason for its selection?
Does your organization have SOPs for waste recovery and decontamination of any wastes remaining after separation and purification?
Are your organization and production measuring instruments that are important for the quality of the product calibrated regularly?
Are your organization and testing facilities appropriate for work with infectious agents or potentially infectious materials?

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 Good Laboratory Practice book in PDF containing 997 requirements, which criteria correspond to the criteria in...

Your Good Laboratory Practice 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 Good Laboratory Practice Self-Assessment and Scorecard you will develop a clear picture of which Good Laboratory Practice 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 Good Laboratory Practice 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 Good Laboratory Practice projects with the 62 implementation resources:

62 step-by-step Good Laboratory Practice Project Management Form Templates covering over 1500 Good Laboratory Practice project requirements and success criteria:

Examples; 10 of the check box criteria:

Procurement Audit: Are fixed asset values recorded at historical cost?
Scope Management Plan: Does the Good Laboratory Practice project team have the skills necessary to successfully complete current Good Laboratory Practice project(s) and support the application?
Risk Register: Are there any knock-on effects/impact on any of the other areas?
Human Resource Management Plan: Is a stakeholder management plan in place that covers topics?
Human Resource Management Plan: How will the Good Laboratory Practice project manage expectations & meet needs and requirements?
Schedule Management Plan: Are the processes for schedule assessment and analysis defined?
Human Resource Management Plan: How do you determine what key skills and talents are needed to meet the objectives. Is your organization primarily focused on a specific industry?
Probability and Impact Assessment: Which risks need to move on to Perform Quantitative Risk Analysis?
Stakeholder Management Plan: Are issues raised, assessed, actioned, and resolved in a timely and efficient manner?
Project Management Plan: Are the proposed Good Laboratory Practice project purposes different than a previously authorized Good Laboratory Practice project?

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

1.0 Initiating Process Group:

1.1 Good Laboratory Practice project Charter
1.2 Stakeholder Register
1.3 Stakeholder Analysis Matrix

2.0 Planning Process Group:

2.1 Good Laboratory Practice project Management Plan
2.2 Scope Management Plan
2.3 Requirements Management Plan
2.4 Requirements Documentation
2.5 Requirements Traceability Matrix
2.6 Good Laboratory Practice project Scope Statement
2.7 Assumption and Constraint Log
2.8 Work Breakdown Structure
2.9 WBS Dictionary
2.10 Schedule Management Plan
2.11 Activity List
2.12 Activity Attributes
2.13 Milestone List
2.14 Network Diagram
2.15 Activity Resource Requirements
2.16 Resource Breakdown Structure
2.17 Activity Duration Estimates
2.18 Duration Estimating Worksheet
2.19 Good Laboratory Practice project Schedule
2.20 Cost Management Plan
2.21 Activity Cost Estimates
2.22 Cost Estimating Worksheet
2.23 Cost Baseline
2.24 Quality Management Plan
2.25 Quality Metrics
2.26 Process Improvement Plan
2.27 Responsibility Assignment Matrix
2.28 Roles and Responsibilities
2.29 Human Resource Management Plan
2.30 Communications Management Plan
2.31 Risk Management Plan
2.32 Risk Register
2.33 Probability and Impact Assessment
2.34 Probability and Impact Matrix
2.35 Risk Data Sheet
2.36 Procurement Management Plan
2.37 Source Selection Criteria
2.38 Stakeholder Management Plan
2.39 Change Management Plan

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 Good Laboratory Practice 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 Good Laboratory Practice 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 Good Laboratory Practice project with this in-depth Good Laboratory Practice Toolkit.

In using the Toolkit you will be better able to:

Diagnose Good Laboratory Practice 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 Good Laboratory Practice 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 Good Laboratory Practice investments work better.

This Good Laboratory Practice 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.

TRUSTED BY NEARLY 200.000 PROFESSIONALS:

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Checklists:

Checklists:Good Laboratory Practice Checklist Report on LABORATORY.pdf

Checklists:Good Laboratory Practice Checklist Report on METHOD.pdf

Checklists:Good Laboratory Practice Checklist Report on SYSTEM.pdf

Checklists:Good Laboratory Practice Checklist Report on EQUIPMENT.pdf

Checklists:Good Laboratory Practice Checklist Report on CONTROL.pdf

Checklists:Good Laboratory Practice Checklist Report on TEST.pdf

Checklists:Good Laboratory Practice Checklist Report on DATA.pdf

Checklists:Good Laboratory Practice Checklist Report on MANAGEMENT.pdf

Checklists:Good Laboratory Practice Checklist Report on QUALITY.pdf

Checklists:Good Laboratory Practice Checklist Report on ORGANIZATION.pdf

Checklists:Good Laboratory Practice Checklist Report on INFORMATION.pdf

STEP 1 Get your bearings:

STEP 1 Get your bearings:Good_Laboratory_Practice_Quick_Exploratory_Self-Assessment_Guide.pdf

STEP 1 Get your bearings:Good Laboratory Practice Self-Assessment Pre-Filled EXAMPLE.xlsx

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

STEP 2 Set concrete goals tasks dates and numbers you can track:Good_Laboratory_Practice.pdf

STEP 2 Set concrete goals tasks dates and numbers you can track:Good Laboratory Practice Self-Assessment.xlsx

..and the Project Management resources in 'STEP 3: Implement, Track, follow up and revise strategy' as described above.

Who This Toolkit Is For

This Toolkit is specifically designed for professionals who want to get results or those who want to sell more of their products and services such as…

Coaching or Consulting
Online Courses
Masterminds
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Events and seminars
Software / SaaS
Done-for-you Services

Bottom line, if you are managing high-end products and services, this toolkit will help you know more, see more and sell more - as well as train your people and co-workers to do so.

If you are a professional who wants to level-up, this Toolkit will help you do exactly that. And if you ever decide to launch products or services, this Toolkit will give you the skills that will not only serve you today as a professional but also in the future as an entrepreneur.

These skills will enrich every part of your life.

Are you ready to get started?

Are you clear on what you are struggling with, want to figure out what the problem is, diagnose it, and get a solution? The solution is something this Toolkit can provide, and we believe it can solve your problem, but you have to decide if you want to become a part of it or not.

Decision Making:

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The answer to this question is your REAL pain:

Why do you think this problem exists?
What have you tried to fix it?
How long has this been a problem?
Is this problem affecting your life in other ways, and how?

Tried:

What have you tried so far to fix this? Is there pain of frustration to solve this all on your own?

This Toolkit gives you your proven advisor, an advisor the vast majority of professionals do not use, because they do not know it exists. If you have tried Toolkits before, so have everyone else of our 200.000 clients. Once they use this Toolkit, they are shocked as to how they quickly get results.

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This toolkit will give you the exact quantifiable metrics in your situation; identifying where exactly you are in the journey to solving your problem and what that looks like.

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The reason WHY you want something always comes down to either love or status - have clarity on your WHY.

Ownership:

What is stopping you from achieving this all on your own without any help? If your answer is one of these three answers, this Toolkit is right for you:

I do not know how to do it
I want to follow a proven process from someone that has already done it
I want to get there faster

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The fact is, it is never a good time, it is never a good time to start a new program, and it is never a good time to fix a major problem. And even if you think a later time is a good time, you know something will come up. Life will keep happening. If you truly want to solve this problem, would you agree you have to commit to solving it even when it is not the perfect time?

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