GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines)
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A01=Leonard Steinborn
academic reference for regulatory compliance
Active Implantable Medical Devices
administration
Audit Program
Audit Team Leader
Author_Leonard Steinborn
Batch Production Record
Category=KFCM
Category=KJMQ
controlled
Controlled Substances
drug
Drug Product
Drug Product Containers
EC regulatory standards
enforcement
eq_bestseller
eq_business-finance-law
eq_isMigrated=1
eq_isMigrated=2
eq_nobargain
eq_non-fiction
FDA compliance procedures
healthcare manufacturing audits
IEC
Implantable Medical Devices
IPEC guideline interpretation
ISO BSI conformity assessment
ISO Member Body
ISO Quality Audit Manual
ISO Technical Committee
MEDICAL DEVICE REPORTING
Medical Devices
narcotic
Narcotic Treatment Program
Nonconforming Product
number
OTC Drug Product
pharmaceutical quality assurance
Positive System
program
Quality Audit
Quality System Requirements
Raw Material
registration
Reserve Samples
Schedule Ii
Scope
Sterile Medical Device
substance
treatment
Product details
- ISBN 9780849318474
- Weight: 1000g
- Dimensions: 210 x 280mm
- Publication Date: 30 Dec 2004
- Publisher: Taylor & Francis Inc
- Publication City/Country: US
- Product Form: Hardback
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This well-known QA manual has been updated to provide the guidance readers need to assess their compliance with standard regulations. This Volume 2 of a three-part package contains the full text on:
* FDA regulations
* EC and IPEC guidelines
* ISO/BSI standards referenced in the checklists furnished in volume 1
Easy-to-read and organized to provide fast access to guidelines and regulations, this is an essential reference for those working in the field.
Steinborn, Leonard
