Title: Change Control for Fda Regulated Industries : A Risk Assessment Approach
Publisher: Authorhouse
Publication Date: 2007
Language: English
ISBN 10: 1434314677
ISBN 13: 9781434314673
Binding: Soft cover
Condition: New

About this title

Synopsis

This book accomplishes the following: .It addresses requirements for Pharmaceutical, Medical Device, Biologics, and Tissue banking change control .Defines the different phases of the change control life cycle .Establishes the relationship between risk management, cost of doing business and change control .Defines regulatory requirements for change control, including requirements for (510k) submission .Provides tools for risk assesment, and cost/benefit analysis .Helps the reader design a 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 five 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.

"About this title" may belong to another edition of this title.

Store Description

GreatBookPrices.com is your top source for finding new books at the absolute lowest prices, guaranteed ! We offer big discounts - everyday - on millions of titles in virtually any category, from Architecture to Zoology -- and everything in between. Discover great deals and super-savings, on professional books, text book titles, the newest computer guides, or your favorite fiction authors. You'll find it all - at HUGE SAVINGS - at GreatBookPrices. Browse through our complete online product catalog today. Serving customers around the world for years, we help thousands find just the books they're looking for -- at incredibly low, bargain prices.

Visit Seller's Storefront

Seller's business information

Far Corner Europe Limited
19-20 Bourne Court, 19-20 Bourne Court, Woodford Green, IG8 8HD, United Kingdom

Sale & Shipping Terms

Terms of Sale

Company Name: GreatBookPricesUK
Legal Entity: Far Corner Europe Limited
Address: 19-20 Bourne Court, Southend Road, Woodford Green Essex, UK IG8 8HD
Registration #: 10691061
Authorized representative: Danielle Hainsey

Shipping Terms

Our warehouses across the globe are fully operational without substantial delays. We are working hard and continue to overcome the daily challenges presented by COVID-19. There have been reports that delivery carriers are experiencing large delays resulting in longer than normal deliveries to customers. See USPS's website for further detail. We would like to apologize in advance if your item arrives later than the expected delivery due date.

Internal processing of your order will take about 1-2 business days. Please allow an additional 4-14 business days for Media Mail delivery. We have multiple ship-from locations - MD,IL,NJ,UK,IN,NV,TN & GA

Shipping rates from United Kingdom to U.S.A.

Shipping rates from United Kingdom to U.S.A.
Order quantity	10 to 30 business days	10 to 27 business days
First item	US$ 20.01	US$ 20.01

Delivery times are set by sellers and vary by carrier and location. Orders passing through Customs may face delays and buyers are responsible for any associated duties or fees. Sellers may contact you regarding additional charges to cover any increased costs to ship your items.