CHANGE CONTROL FOR FDA REGULATED INDUSTRIES
A RISK ASSESMENT APPROACH
by
Book Cover & Preview Text
-----Failure to establish and maintain an adequate procedure for evaluating design changes through risk analysis is a violation of 21CFR 820.30(g)-----
---Change control protects the organization from regulatory exposure,waste,and unindented consequences like; lawsuits, customer returns,recalls,and fines------
---Change control is a risk management Quality subsystem that protects the organization against unindented consequences-----
----Change control is a cross-functional Quality subsystem---
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Book Details
About the Book
Next to CAPA,change control is the most audited Quality subsystem by FDA inspectors.Failure to have a robust change control system exposes the organization to regulatory compliance risk,it encourages waste of company resources,and increases the cost of doing business due to waste. This book accomplishes the following for the reader:
.It addresses requirements for Pharmaceutical,Medical Device,Biologics,and Tissue banking change control
.It defines the different phases of the change control life cycle
.It establishes the relationship between risk management,cost of doing business and change control
.It defines regulatory requirements for change control,including requirements for (510k) submission
.It provides tools for risk assessment,and cost/benefit analysis
.It helps the reader design a centralized Change control system that meets and exceeds cGMP requirements
About the Author
Mr Muchemu is the founder,and CEO of Quality Systems International,(QSi),LLC,a consulting firm for FDA regulated industries in the capital of the Silcon Valley,(San Jose,CA).He has over twenty years expencience in cGMP companies.He has served in different capacities in the Quality Management arena at Boston Scientific,Johnson and Johson,Genentech,American Redcross Biomedical services,Applied Biosystems and Tissue Banks international.Mr Muchemu is an advocate of profitability through compliance,and continous process improvement.