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International GMP's for Medical Devices: Quality System requirements for USA, Europe, Canada and Japan

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This webinar will provide valuable assistance to all medical device and IVD companies that must comply with domestic and international regulations for their quality systems.

Speaker
Instructor: Phil Smart
Product ID: 700844
Description

Most notable of these would include USA (21CFR820), Canada (CMDR + ISO 13485), Europe (MDD Annex II.3 + ISO 13485) and Japan (JPAL Ordinance 169 + ISO 13485).

Often medical device manufacturers must comply with various regulatory schemes from across the globe. Most notable of these would include USA (21CFR820), Canada (CMDR + ISO 13485), Europe (MDD Annex II.3 + ISO 13485) and Japan (JPAL Ordinance 169 + ISO 13485). This presentation will review the GMP requirements from these four regulations. It will provide an understanding of the main differences, similarities and synergies when operating a single quality management system designed to comply with quality management expectations from all regulatory bodies.

Areas Covered in the seminar:

Who will benefit:
This webinar will provide valuable assistance to all medical device and IVD companies that must comply with domestic and international regulations for their quality systems. The employees who will benefit most include:

Instructor Profile:
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, ISO 13485, ISO 9001, ISO 14971, ISO 14644, ISO 14698 as well as 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 families, risk management, electrical safety testing, terminal EtO and Gamma sterilization, sterile packaging, environmental controls and clinical diagnostic laboratories.

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"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 only 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."
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Testimonials:
This Webinar was very well presented and covered alot of material in the time allowed. This answered/tied together a great number of questions.
- Anonymous

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Training Options Training Duration = 60 Min
$299.00 Access Recorded Version Only
One Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section
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CD and Ref. material will be shipped within 15 business days