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.
