Skip to content

Quality Systems and GMP Regulations for Device Manufacturers
Stock Photo: Cover May Be Different

Quality Systems and GMP Regulations for Device Manufacturers Hardcover - 1998

by Steven Kuwahara


From the publisher

This book provides a single roadmap for compliance with the US QSR, the European Medical Device Directives, and ISO Standards for device and diagnostic products. Written in case-study format, it begins with information on how to establish a QSR documentation system. Dr. Kuwahara explains implementation methods for each section of the QSRs (21 CFR 820). Documentation requirements and guidelines for what documentation you need for your quality system, why you need it, and how to prepare it are detailed, as well as practical information on efficiently and effectively organizing your records, procedures, work instructions, and Quality Manual. The book shows you how to evaluate your existing documentation's fit with the worldwide quality systems and the GMPs/QSRs. A grid comparing ISO 9001 and US 21 CFR 820 requirements is included.

Details

  • Title Quality Systems and GMP Regulations for Device Manufacturers
  • Author Steven Kuwahara
  • Binding Hardcover
  • Edition 2nd
  • Pages 256
  • Volumes 1
  • Language ENG
  • Publisher CRC Press, Milwaukee, Wisconsin, U.S.A.
  • Date 1998-03
  • ISBN 9780873894265 / 087389426X
  • Weight 0.01 lbs (0.00 kg)
  • Library of Congress Catalog Number 98010632
  • Dewey Decimal Code 344.730
Back to Top

More Copies for Sale

Quality Systems and GMP Regulations for Device Manufacturers
Stock Photo: Cover May Be Different

Quality Systems and GMP Regulations for Device Manufacturers

by Kuwahara, Steven

  • Used
  • good
  • Hardcover
Condition
Used - Good
Binding
Hardcover
ISBN 10 / ISBN 13
9780873894265 / 087389426X
Quantity Available
1
Seller
Seattle, Washington, United States
Seller rating:
This seller has earned a 4 of 5 Stars rating from Biblio customers.
Item Price
€6.50
FREE shipping to USA

Show Details

Description:
CRC Press, 1998. Hardcover. Good. Missing dust jacket; Pages can have notes/highlighting. Spine may show signs of wear. ~ ThriftBooks: Read More, Spend Less.Dust jacket quality is not guaranteed.
Item Price
€6.50
FREE shipping to USA
Quality Systems and GMP Regulations for Device Manufacturers : A Practical Guide to U. S.,...

Quality Systems and GMP Regulations for Device Manufacturers : A Practical Guide to U. S., European and ISO Requirements

by Steven Strauss; Steven S. Kuwahara

  • Used
  • good
  • Hardcover
Condition
Used - Good
Binding
Hardcover
ISBN 10 / ISBN 13
9780873894265 / 087389426X
Quantity Available
1
Seller
Seattle, Washington, United States
Seller rating:
This seller has earned a 4 of 5 Stars rating from Biblio customers.
Item Price
€6.50
FREE shipping to USA

Show Details

Description:
CRC Press LLC, 1998. Hardcover. Good. Disclaimer:A copy that has been read, but remains in clean condition. All pages are intact, and the cover is intact. The spine may show signs of wear. Pages can include limited notes and highlighting, and the copy can include previous owner inscriptions. At ThriftBooks, our motto is: Read More, Spend Less.Dust jacket quality is not guaranteed.
Item Price
€6.50
FREE shipping to USA
Quality Systems and GMP Regulations for Device Manufacturers : A Practical Guide to U. S.,...
Stock Photo: Cover May Be Different

Quality Systems and GMP Regulations for Device Manufacturers : A Practical Guide to U. S., European and ISO Requirements

by Strauss, Steven, Kuwahara, Steven S

  • Used
Condition
Used - Very Good
ISBN 10 / ISBN 13
9780873894265 / 087389426x
Quantity Available
1
Seller
Mishawaka, Indiana, United States
Seller rating:
This seller has earned a 5 of 5 Stars rating from Biblio customers.
Item Price
€6.95
FREE shipping to USA

Show Details

Description:
Taylor & Francis Group. Used - Very Good. Used book that is in excellent condition. May show signs of wear or have minor defects.
Item Price
€6.95
FREE shipping to USA
Quality Systems and GMP Regulations for Device Manufacturers: A Practical Guide to US, European,...
Stock Photo: Cover May Be Different

Quality Systems and GMP Regulations for Device Manufacturers: A Practical Guide to US, European, and ISO Requirements

by Steven Kuwahara

  • Used
  • Hardcover
Condition
Used: Good
Binding
Hardcover
ISBN 10 / ISBN 13
9780873894265 / 087389426X
Quantity Available
1
Seller
HOUSTON, Texas, United States
Seller rating:
This seller has earned a 4 of 5 Stars rating from Biblio customers.
Item Price
€8.45
FREE shipping to USA

Show Details

Description:
CRC Press, 1998-03-31. Hardcover. Used: Good.
Item Price
€8.45
FREE shipping to USA
Quality Systems and GMP Regulations for Device Manufacturers
Stock Photo: Cover May Be Different

Quality Systems and GMP Regulations for Device Manufacturers

by Kuwahara, Steven

  • Used
Condition
Used - Good
ISBN 10 / ISBN 13
9780873894265 / 087389426x
Quantity Available
1
Seller
Frederick, Maryland, United States
Seller rating:
This seller has earned a 4 of 5 Stars rating from Biblio customers.
Item Price
€18.89
€3.77 shipping to USA

Show Details

Description:
CRC Press. Used - Good. Good condition. A copy that has been read but remains intact. May contain markings such as bookplates, stamps, limited notes and highlighting, or a few light stains.
Item Price
€18.89
€3.77 shipping to USA
Quality Systems and GMP Regulations for Device Manufacturers
Stock Photo: Cover May Be Different

Quality Systems and GMP Regulations for Device Manufacturers

by Kuwahara, Steven

  • New
  • Hardcover
Condition
New
Binding
Hardcover
ISBN 10 / ISBN 13
9780873894265 / 087389426X
Quantity Available
1
Seller
San Diego, California, United States
Seller rating:
This seller has earned a 5 of 5 Stars rating from Biblio customers.
Item Price
€64.05
€5.15 shipping to USA

Show Details

Description:
CRC Press, 1998-03-31. Hardcover. New. New. In shrink wrap. Looks like an interesting title!
Item Price
€64.05
€5.15 shipping to USA
Quality Systems and GMP Regulations for Device Manufacturers: A Practical Guide to U.S.,...
Stock Photo: Cover May Be Different

Quality Systems and GMP Regulations for Device Manufacturers: A Practical Guide to U.S., European, and ISO Requirements

by Kuwahara, Steven S.

  • Used
  • near fine
  • Hardcover
Condition
Used - Near Fine
Binding
Hardcover
ISBN 10 / ISBN 13
9780873894265 / 087389426X
Quantity Available
1
Seller
Vancouver, Washington, United States
Seller rating:
This seller has earned a 5 of 5 Stars rating from Biblio customers.
Item Price
€64.62
€6.14 shipping to USA

Show Details

Description:
Milwaukee, Wisconsin, U.S.A.: Asq Pr, 1998. Hardback in near fine condition. Small name on first blank page.. Hardcover. Near Fine.
Item Price
€64.62
€6.14 shipping to USA