A comprehensive audit of relevant clinical investigations is now expected to determine if the clinical trials and clinical trial systems are effectively documented and implemented.
With revisions to the Pharmaceutical Affairs Law (PAL) and GCP Ordinance 36, there is an increased focus on clinical data and how it is presented to the PMDA/MHLW. A comprehensive audit of relevant clinical investigations is now expected to determine if the clinical trials and clinical trial systems are effectively documented and implemented. This audit should be proceduralized and should be based on both Ordinance 36 as well as ISO 15144 parts 1 and 2.
Areas Covered in the seminar:
Who will benefit:
This webinar will provide valuable assistance to regulated companies which employ regulatory affairs associates, clinical specialists, internal auditors, audit managers and personnel of JPAL-regulated medical device or IVD companies. The employees who will benefit include:
Phil Smart, is a founding member of RA/QA International LLC. He serves the medical device community as Consultant, Facilitator and Instructor to 21 CFR Part 820, CMDR/CMDCAS, MDD, MHLW/PMDA/Japanese PAL. He has been a European Notified Body Lead Assessor for over 15 years with auditing experience in a wide range of active and non-active medical device clinical evaluations and clinical monitoring. He was head of TUV PS Japan for several years and continues to provide consultation and independent audit support to ensure effective compliance to Japanese PAL and its ordinances.
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 [email protected] call +1-888-717-2436 (Toll Free).
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