Japanese PAL - Dealing with a JPAL Quality Interface Agreement between the foreign manufacturer and MAH (Marketing Authorization Holder)

Instructor: Phil Smart
Product ID: 701277
  • Duration: 90 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Apr-2009

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

This JPAL training will describe requirements, common mistakes & best practices while dealing with a JPAL Quality Interface Agreement between the foreign manufacturer and MAH (Marketing Authorization Holder).

The 2005 revisions to the Japanese Pharmaceutical Affairs Law (PAL) are in force. This presentation will explore the Quality Interface Agreement, a necessary document which underscores the high level of "control" to be exhibited by the Japanese Marketing Authorization Holder (MAH) over its foreign manufacturer (FM). The session will go into the key relationship between the foreign manufacturer and the MAH/DMAH, the basis and rationale for an agreement, minimum requirements, recommended points to consider as well as potential pitfalls and best practices.

Areas Covered in the seminar:
  • The MAH/FM relationship in a "Japan-centric" scheme.
  • Background and regulatory basis of the Quality Interface Agreement via Ord. 136 (GQP).
  • Contents of the QAI including:
    • Scope and organizational interfaces.
    • Technical requirements.
    • Periodic verification.
    • Transportation and delivery.
    • Change control.
    • Post-market support and field actions.
    • Clinical trial audits and certification.
    • CAPA.
  • Additional considerations including internal audits, nonconformance management, record retention.
  • Leveling the playing field through best practices such as MAH representation, cross-functional audits and strong communication.

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.

He has been a European Notified Body Lead Assessor and Monitoring Auditor for over 15 years with auditing experience in a wide range of active and non-active medical device technologies.

Follow us :
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Refund Policy

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.

If you have any concern about the content of the webinar and not satisfied 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 call +1-888-717-2436 (Toll Free).

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