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Japanese PAL – JPAL QMS requirements in Ordinance 169 and differences to ISO 13485
This JPAL (Japanese Pharmaceutical Affairs Law) QMS training/webinar will explore, in detail, the QMS requirements placed on the foreign manufacturer via Ministerial Ordinance 169, Ordinance 2 and Ordinance 179.
Description
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, discussing actual case studies and 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.
- Case studies from foreign manufacturers audited in USA.
Who Will Benefit:
- This webinar will provide valuable assistance to quality, regulatory and manufacturing associates, whose companies sell or plan to sell their medical or pharmaceutical products in Japan.
Instructor Profile:
Phil Smart, is a founding member and Regulatory Consultant of RA/QA International LLC. He serves as Consultant, Auditor and Instructor, covering medical device regulations and standards within the US, Europe, Canada and Japan. He has spent over seven years in Tokyo and is a former head of operations and medical device assessment activities for TUV in Japan.
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