CGMP A Complete Guide - 2021 Edition
146 pages
English

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146 pages
English

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Description

Are post approval change management protocols applicable to all types of applications?

Are there situations where you could make a change and notify organization after the fact?

Do the cGMPs permit the identity test on a pooled, or composite, sample of multiple containers?

Do you have a policy to govern outsourced activities services, material and suppliers?

Have you set annual targets and incentives related to the avoidance of drug shortages?

How should access to cGMP Infrastructure Provisioning systems be restricted?

How, if at all, should the cGMP regulations be revised to take into account variation?

Is it ever appropriate to use an unvalidated method to test a drug component or product?

What about using the drug cGMPs if the primary mode of action is as a device?

Who is the person authorized to dispense and/or administer the drug/device to the subject?



This CGMP Guide is unlike books you're used to. If you're looking for a textbook, this might not be for you. This book and its included digital components is for you who understands the importance of asking great questions. This gives you the questions to uncover the CGMP challenges you're facing and generate better solutions to solve those problems.

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


Unless you're talking a one-time, single-use project, there should be a process. That process 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 Self-Assessment 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 CGMP investments work better.


This CGMP All-Inclusive Self-Assessment enables You to be that person.


INCLUDES all the tools you need to an in-depth CGMP Self-Assessment. Featuring new and updated case-based questions, organized into seven core levels of CGMP maturity, this Self-Assessment will help you identify areas in which CGMP improvements can be made.


In using the questions you will be better able to:


Diagnose CGMP 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 CGMP and process design strategies into practice according to best practice guidelines.


Using the Self-Assessment tool gives you the CGMP Scorecard, enabling you to develop a clear picture of which CGMP areas need attention.



Your purchase includes access to the CGMP self-assessment digital components which gives you your dynamically prioritized projects-ready tool that enables you to define, show and lead your organization exactly with what's important.


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Informations

Publié par
Date de parution 03 janvier 2021
Nombre de lectures 0
EAN13 9781867465379
Langue English

Informations légales : prix de location à la page 0,3850€. Cette information est donnée uniquement à titre indicatif conformément à la législation en vigueur.

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