You are on page 1of 2

PRE-PUBLICATION

Pharmaceutical Regulatory Inspections

ISBN 978-1-899015-89-4

Order form

Ordering information

Order by fax +44-(0)1428 752223 or mail this Order Form or order online at www.euromedcommunications.com.

All orders to be sent to:

Euromed Communications Ltd, Passfield Business Centre, Lynchborough Road, Passfield, Hampshire GU30 7SB, UK

Payment

Cheque enclosed for £ payable to Euromed CommunicationsLynchborough Road, Passfield, Hampshire GU30 7SB, UK Payment Payment, net of charges, must be made in

Payment, net of charges, must be made in £ sterling drawn on a UK bank.

Please invoice me (Payment must be made within 28 days of invoice)of charges, must be made in £ sterling drawn on a UK bank. Charge my You

Charge myinvoice me (Payment must be made within 28 days of invoice) You can also order from

You can also order from your bookseller

Send my copy to: (Please PRINT)

Name

Organisation

Address

Visa (£ only)Send my copy to: (Please PRINT) Name Organisation Address Mastercard (£ only) American Express (£ only)

Mastercard (£ only)to: (Please PRINT) Name Organisation Address Visa (£ only) American Express (£ only) Card No Expiry

American Express (£ only)Organisation Address Visa (£ only) Mastercard (£ only) Card No Expiry date Security code Signature Date

Card No

Expiry date

Security code

Signature

Date

Post/Zip code

Country

Fax No

Email

NOTE: If you pay by credit card we need the name and address of the cardholder if different from above. (Please enclose details with order)

Companies in EU countries (excluding UK) must supply their Sales Tax Number.

Our Sales Tax (VAT) No. is GB 615 4655 40

Price £395 £355 Pre-publication price – valid until 31 Jan 2013 Printed or online version

Price £395

£355

Pre-publication price valid until 31 Jan 2013

Printed or online version

For a corporate licence, please contact publisher

Plus carriage (for printed copy) UK £10, Europe £15, RoW £20

OFFER PHARMACEUTICAL REGULATORY INSPECTIONS GUIDE A TO SUCCESS MAKE IT STORY “EVERY INSPECTION – A
OFFER
PHARMACEUTICAL
REGULATORY
INSPECTIONS
GUIDE A TO SUCCESS
MAKE IT STORY
“EVERY
INSPECTION
A
PRACTICAL
HAPPEN"
E D I T E D B Y
M
A D H U A J U A G H E E
R
S

MAKE EVERY INSPECTION A SUCCESS STORY A PRACTICAL GUIDE TO MAKE IT HAPPEN

Pharmaceutical Regulatory Inspections -

a practical guide

Editor: Madhu Raju Saghee

Contains a practical advice and insight to help different types of pharmaceutical organisations prepare for GMP inspections, understand key regulatory issues and review inspectorate trends and findings.

Expert advice

This is a unique book in which agency inspectors express their views and provide tips for succeeding in regulatory inspections.

No other book captures such a diverse range of experts to provide a focussed account of regulatory issues from pre- approval inspections, the inspection itself to post- inspection and maintaining compliance.

International

The book compares inspection by the major regulatory agencies, the FDA, EU and Japan, as well as international inspections.

Make every inspection a success story

Contents

1. Basic Concepts of Global GMP

Requirements by Tim Sandle & Madhu Raju Saghee

2. FDA Drug Regulation and

Enforcement by Seth Mailhot

3. System Based Approach to

Inspections by David Barr & Tim Sandle

4. Preparing for Preapproval

Inspections by Ron Johnson

7. Regulatory Requirements of

Japanese GMP Inspections

by Yoshikazu Hayashi

8. Preparing and Management of

International Inspections by Andreas Brutsche & Tim Sandle

9. Handling and Responding to Post

inspectional Observations by Tim Sandle, Madhu Raju Saghee & David Barr

10. Preparing for Regulatory

Inspections of Sterile Facilities:

 

The Focal Points

5.

Effectively Managing and

by Tim Sandle

Surviving FDA Inspections

by John Avellanet

6. Guide for Successful EU

Inspection Management by Siegfried Schmitt & Nabila Nazir

11. Preparing for Regulatory

Inspections of API Facilities:

The Focal Points by Siegfried Schmitt & Richard Einig

12. Optimizing your Regulatory

Compliance by Mark Tucker

Editor:

Madhu Raju Saghee

Published by:

by Mark Tucker Editor: Madhu Raju Saghee Published by: Passfield Business Centre, Lynchborough Road,

Passfield Business Centre, Lynchborough Road, Passfield,Hampshire GU30 7SB

Tel: 44 (0) 1428 752222

Fax: +44 (0) 1428 752223

www.euromedcommunications.com