The GMP board game that tests and improves your GMP compliance, knowledge, attitude and awareness!
The GMP Handbook for pharmaceuticals
Quality Systems Handbook for MedDev
E-books: US and EU regulations
GMP translations (FR, SE, DK)
Search tool and document library. Find your way in regulations, guides and other reference documents.
After thousands of training hours in the Medical Device industry, Anna Lundén has earned a good understanding for what kind of GMP/QSR knowledge that is requested, both for the employees in this industry as well as for people in adjacent companies as suppliers, consultants and contractors.
Now Anna Lundén have gathered the most important facts in one book:
Basic knowledge about GMP/QSR in a clear and easy to read style
Comparison of similarities and differences in requirements and terminology in ISO 13485 and US QSR (21 CFR 820)
Tables with specific references to requirements in ISO 13485
and 21 CFR 820Suitable for self studies and to note references to one’s own activities
Price (excl. VAT & freight): |
€ 35 |
5-10 pcs |
10% |
11-19 pcs |
15% |
20+ pcs |
20% |
Samples from the book (PDF format): |
Price |
€ 35 (excl. VAT & freight): |
Part no |
EN1313 |
Author |
Anna Lundén |
Pages |
122 |
Language |
English |
Publisher |
Key2Compliance AB |
Published |
2010-04-01-09 |
Edition |
1 |
ISBN |
978-91-977151-5-7 |
Key2Compliance AB and EuroGMP AB • Tjädervägen 10 • SE-181 56 Lidingö • SWEDEN • Tel: +46-(0)8-544 811 60 • e-mail: info@key2compliance.com
