Event Date/Time: Apr 24, 2009
The 2005 revisions to the Japanese Pharmaceutical Affairs Law (PAL) are in force. This presentation will explore, in detail, the QMS requirements placed on the foreign manufacturer via Ministerial Ordinance 169, Ordinance 2 and Ordinance 179. We will go into the differences, point by point, between Ord. 169 and ISO 13485, showing requirements as well as common issues seen by manufacturers having been audited by the PMDA.
Areas Covered in the seminar:
* Overview of QMS requirements within the JPAL.
* The Foreign Manufacturer Accreditation process.
* Ministerial Ordinance 169 (general QMS - Medical Devices).
* Ministerial Ordinance 179 (Pharmaceuticals).
* Ministerial Ordinance 2 (Buildings and Facilities).
* Key Differences and Similarities between Ordinance 169 and ISO 13485.
* Ministerial Notification YAKUSHOKUKANMA 0330001.
* Special considerations for a successful PMDA audit.
* Internal Audits to cover JPAL, Ord. 2, 169 and 179.