Success with Multi-Site Audits Observations underPharmaceutical Affairs Law in Japan (On-Demand Webinar)

Description

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This thirty-minute on-demand webinar module is presented by Seiko Ohyama, lead auditor and primary reviewer for all Japan PAL technical files submitted through UL Japan for 3rd party review.  This course is designed to help companies put their medical devices on the Japanese market.

Topics covered:

• An overview of Japan’s Pharmaceutical Affairs Law
• The protocols for Japan PAL-QMS inspections
• Keys to making a good impression on the auditor
• Common non-conformities found during PAL-QMS audits
• Decision trees to help you understand who to contact and what forms are required.
• The requirements for using a 3rd party reviewer for class 2 designated medical devices to obtain authorization for the Japanese Market:
• Selecting the right third party reviewer for your products and company
• Preparing the application for third party review.
• A comparison between ISO 13485 and PAL-QMS is provided with a brief explanation
• General requirements for the MAH
• A reference list of common abbreviations under PAL
  
• A list showing what is required for accreditation

Objectives

• Understand the regulatory certification structure for Class I, II and III medical devices in Japan for both domestic and foreign manufacturers
• Recognize the differences between CE mark and PAL
• Understand the role of the Market Authorization Holder (MAH)
• Distinguish between ISO 13485 and Japan PAL-QMS
• Select the correct third party reviewer for your products and company
• Learn the application requirements for third party review
• Know what to expect during a PAL audit
  

Target Audience

• Professionals from small to large size medical device companies interested in introducing their medical devices on the Japanese market.
• Regulatory affairs professionals
• Quality system engineers
• Quality assurance professionals

UL University's workshops are designed for and intended to serve individuals using and relying upon UL services. UL University reserves the right to limit workshop attendance strictly to the foregoing. In addition, UL University reserves the right to change, reschedule or cancel any workshop at any time. UL shall not be responsible for any consequential or other losses resulting from the cancellation or postponement of this workshop such as airline and other travel/personal expenses.

UL University accepts the following forms of payment for registration: Visa, MasterCard, American Express and Invoice/PO. Please note that Invoice/PO is not accepted for online courses.