GMP Certified Toolkit

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Does your organization have investigated the complaint and has taken any corrective action?

How did your organization know that the system was operating in a controlled and consistent manner?

How is a design space initially developed and verified at commercial scale?

What is the purpose of design space verification at commercial scale?

How can a design space be verified at commercial scale?




...Find the answers to these, and more, questions with this GMP Certified Toolkit:

  • Get your team trained and certified on Cloud technology.
  • Partner with the new certified peer specialists who are now on staff in your program.
  • Find out your potential subs certified CMMC levels.
  • Include Certified Partners in your response.
  • Drive competition into the cloud market and ensure a level playing field for competitors so your organization can ensure best value for the service.
  • Reduce the load on your on premises database resources in the most cost effective way.
  • Evaluate your business impartially, and make sure its poised for future success, without letting emotions cloud your vision.
  • Ensure that your destination stands out for all the right reasons.
  • Meet your regulatory mandates after moving to the cloud.



HOW THIS TOOLKIT WORKS:

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


STEP 1: Get your bearings

Start with...

  • The latest quick edition of the GMP Certified 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 GMP Certified improvements can be made.

Examples; 10 of the 999 standard requirements:

  1. Should a test for identity and assay be performed on one filled container from each manifold filling sequence, or do you rely on the test results provided by the supplier with no further testing?

  2. Are there any investigations in the event of unacceptable calibration results in order to determine whether there is any impact to the quality of the product and are appropriate steps taken?

  3. Are all measured / weighed raw materials filled into clean and suitable containers labelled with appropriate identification and / or directly into the equipment used for bulk manufacturing?

  4. Has it/organization entered into administration or is it experiencing financial difficulty that has/will result in budget cuts affecting good manufacturing practice compliance?

  5. Are aisles and working spaces unobstructed and of adequate width to permit employees to perform jobs and protect against contamination of food by clothing or personal contact?

  6. Are there adequate written and approved instructions and specifications for quality critical material sampling and testing, including investigation of nonconforming results?

  7. Is there an appropriate quality control operation employed to ensure that food is suitable for human consumption and that food packaging material is safe and suitable?

  8. What controls are applied to assure that the excipient conforms to the documented specifications when the excipient is manufactured using a continuous process?

  9. What records are kept to demonstrate that GMP training is conducted in a timely manner for new and temporary employees as well as consultants and contractors?

  10. Are the out-of-specification results reviewed by authorised personnel and properly investigated and is a corresponding decision about uses taken subsequently?


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 GMP Certified book in PDF containing 999 requirements, which criteria correspond to the criteria in...

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

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

Examples; 10 of the check box criteria:

  1. Team Member Performance Assessment: To what degree do team members articulate the teams work approach?

  2. Procurement Management Plan: Have GMP Certified project management standards and procedures been identified / established and documented?

  3. Lessons Learned: Who had fiscal authority to manage the funding for the GMP Certified project, did that work?

  4. Procurement Management Plan: Are there checklists created to determine if all quality processes are followed?

  5. Procurement Audit: If the expert was allowed to submit a tender, was all the relevant information the expert had gained from his earlier involvement made available to the other bidders?

  6. Quality Audit: Are all employees made aware of device defects which may occur from the improper performance of specific jobs?

  7. Schedule Management Plan: Is there general agreement & acceptance of the current status and progress of the GMP Certified project?

  8. Team Operating Agreement: Do you ask participants to close laptops and place mobile devices on silent on the table while the meeting is in progress?

  9. Initiating Process Group: Are identified risks being monitored properly, are new risks arising during the GMP Certified project or are foreseen risks occurring?

  10. Roles and Responsibilities: Attainable / achievable: the goal is attainable; can you actually accomplish the goal?

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

1.0 Initiating Process Group:

  • 1.1 GMP Certified project Charter
  • 1.2 Stakeholder Register
  • 1.3 Stakeholder Analysis Matrix


2.0 Planning Process Group:

  • 2.1 GMP Certified project Management Plan
  • 2.2 Scope Management Plan
  • 2.3 Requirements Management Plan
  • 2.4 Requirements Documentation
  • 2.5 Requirements Traceability Matrix
  • 2.6 GMP Certified 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 GMP Certified 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 GMP Certified 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 GMP Certified 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 GMP Certified project with this in-depth GMP Certified Toolkit.

In using the Toolkit you will be better able to:

  • Diagnose GMP Certified 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 GMP Certified 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 GMP Certified investments work better.

This GMP Certified 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.





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CONTENTS:


Checklists:


Checklists:GMP Certified Checklist Report on TEST.pdf

Checklists:GMP Certified Checklist Report on ORGANIZATION.pdf

Checklists:GMP Certified Checklist Report on PRODUCT.pdf

Checklists:GMP Certified Checklist Report on DATA.pdf

Checklists:GMP Certified Checklist Report on RESULTS.pdf

Checklists:GMP Certified Checklist Report on MATERIALS.pdf

Checklists:GMP Certified Checklist Report on CONTROL.pdf

Checklists:GMP Certified Checklist Report on EQUIPMENT.pdf

Checklists:GMP Certified Checklist Report on QUALITY.pdf

Checklists:GMP Certified Checklist Report on MATERIAL.pdf

Checklists:GMP Certified Checklist Report on PROCESS.pdf



STEP 1 Get your bearings:


STEP 1 Get your bearings:GMP Certified Self-Assessment Pre-Filled EXAMPLE.xlsx

STEP 1 Get your bearings:GMP_Certified_Quick_Exploratory_Self-Assessment_Guide.pdf





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


STEP 2 Set concrete goals tasks dates and numbers you can track:GMP Certified Self-Assessment.xlsx

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

..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
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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 Reason:

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You are here because we have a great reputation in the space, and you specifically want this Toolkit to help you, but why now, why is it so important to solve this right now?

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.

Where do you want to be, what is your desired situation: if you were to use this Toolkit, where would you want to be 12 months from now to feel like the investment was more than worth it?  Make sure you set realistic expectations.

Why:

What is driving you to achieve that goal? How would that affect you or change your life. What would that look like.

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:

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Commitment:

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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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However, if you are wanting to solve your problem, this Toolkit can make that happen.

Which would you like to do?

Our area of expertise is helping professionals to get the results they want so they can lead and get ahead. And we do that by pouring our experience, advise and knowledge in this Toolkit. Now, this may not be for you, but we let you decide if it sounds like a good fit so far.

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