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
- 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 999 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 999 standard requirements:
- Are handling conditions specific to the test substance clearly identified, as temperature conditions or length of storage time before reversion of transformation?
- 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?
- How can industry best practices help you improve performance and reduce costs of one of the most labor intensive functions in the warehouse?
- 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?
- Does the final product label contain adequate information to identify the contents, quantity, batch number, and manufacturer?
- Are your organization and testing facilities appropriate for work with infectious agents or potentially infectious materials?
- How are containers and equipment labelled to clearly identify the contents and, if appropriate, the stage of manufacture?
- How to fulfill regulatory requirements while making the best use of your common sense, knowledge, talents, and resources?
- 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 Good Laboratory Practice book in PDF containing 999 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:
- Stakeholder Analysis Matrix: What resources might the stakeholder bring to the Good Laboratory Practice project?
- Variance Analysis: What types of services and expense are shared between business segments?
- Executing Process Group: What are the Good Laboratory Practice project management deliverables of each process group?
- Team Operating Agreement: Why does your organization want to participate in teaming?
- Project Charter: What are you striving to accomplish (measurable goal(s))?
- Network Diagram: Are the gantt chart and/or network diagram updated periodically and used to assess the overall Good Laboratory Practice project timetable?
- Executing Process Group: Do Good Laboratory Practice project managers understand your organizational context for Good Laboratory Practice projects?
- WBS Dictionary: Is subcontracted work defined and identified to the appropriate subcontractor within the proper WBS element?
- Responsibility Assignment Matrix: Is work properly classified as measured effort, LOE, or apportioned effort and appropriately separated?
- Activity Cost Estimates: Will you need to provide essential services information about activities?
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
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.