Japanese PAL - JPAL QMS requirements in Ordinance 169 and differences to ISO 13485
Instructor:
Phil Smart
Product ID: 701290
- Duration: 90 Min
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.
More Training By Experts
- Internal Auditing of Risk Management: Emphasis on effectiveness and compliance to QSR, ISO 13485 and ISO 14971
- International GMP's for Medical Devices: Quality System requirements for USA, Europe, Canada and Japan
- Risk Management and Internal Auditing: Effective quality audits with inclusion of ISO 14971:2007
- GCP Audit of Clinical Evaluations for Japan: Requirements and expectations from the revised Japanese PAL
- 4-Region internal audits: Medical Device Quality System audits that cover internal regulatory compliance for FDA, Europe, Canada and Japan
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
