| |
|
|
| |
|
|
| |
HUM-MOLGEN
-> Events
-> Courses and Workshops |
|
|
| |
| |
| |
November 07, 2008 |
|
|
| |
|
|
| |
|
|
|
Centre for Applied Training and Development, Webinar
2008-12-16
This webinar will discuss recent developments and revisions in the EU Good Manufacturing Practice (GMP) Guidelines (except for Annex 1 – Manufacture of Sterile Medicinal Products – which is a subject in its own right). It will identify the key issues and clarify the purpose within the new or revised guidelines and also look at the role of the Site Master File. 1. Good manufacturing practice (GMP) Guidelines§ restructuring and organisation2. Part I – Medicinal Products§ Chapter 1 – Quality Management (revision Feb 2008)§ Chapter 6 – Quality Control (revision Oct 2005)§ Chapter 8 – Complaints and Product Recall (revision Dec 2005)§ Annex 19 – Reference and Retention Samples (Dec 2005)§ Annex 20 – Quality Risk Management (Feb 2008)3. Part II – Basic Requirements for Active Substances (ICH Q7 aligned with EU directives)§ Differences from ICH Q7 § Prospective changes (in consultation stage)4. Site Master File§ Requirement or recommendation?§ Purpose and benefits§ Components and key areas
|
|
|
|
|
|
|
|
Organized by:
|
|
Centre for Applied Training and Development |
|
|
Invited Speakers:
|
|
info@catdglobal.com
|
|
|
|
|
|
|
|
Deadline for Abstracts:
|
|
n/a
|
|
|
|
|
|
|
|
Registration:
|
|
Please refer to the register tab on the CATD website (www.catdglobal.com) or click on the title of the course on the Webinar page to register on line.If you have any problem registering please do not hesitate to contact us at info@catdglobal.com or call us at + 44 (0) 20 8485 1234 or fax us at + 44 (0) 20 8485 1234
|
|
|
E-mail:
|
|
info@catdglobal.com
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
Generated by meetings and positions 5.0 by Kai Garlipp
WWW: Kai Garlipp,
Frank S.
Zollmann.
7.0 © 1995- HUM-MOLGEN. All rights reserved.
Liability, Copyright and Imprint. |
|