4-Region internal audits: Medical Device Quality System audits that cover internal regulatory compliance for FDA, Europe, Canada and Japan
Instructor:
Phil Smart
Product ID: 700847
- Duration: 60 Min
All major regulatory schemes require internal audits to be performed by competent, trained individuals, and that these audits go into sufficient depth regarding specific regulatory processes for a given region. Evidence of this is seen through third-party audit findings from FDA, European Notified Bodies, CMDCAS Registrars and MHLW/PMDA. Assessors within the organization should have at least basic knowledge of these regulations and their expectations for internal audits. This presentation will provide an understanding of how to integrate US, Canadian, European and Japanese regulations into an effectively documented and implemented internal audit program.
Areas Covered in the seminar:
- Review of internal audit requirements for QSR, CMDR, MDD and JPAL.
- Principles of Regulatory Auditing of quality management systems per GHTF Guidance documents from 2006 and 2007.
- Developing and internal audit program and documentation which include regulatory assessments.
- What are regulatory processes and how must they comply?
- Audit focus for FDA compliance.
- Audit focus for MDD/AIMDD and IVDD Compliance.
- Audit focus for Canadian Medical Devices Regulations (CMDR) Compliance.
- Audit focus for foreign manufacturers in compliance with Japanese PAL.
Who will benefit:
This webinar will provide valuable assistance to all regulated medical device companies who implement internal audit programs to comply with US and international regulations. The employees who will benefit include:
- Internal auditors, audit managers and 2nd-party auditors performing assessments of regulatory processes
- Regulatory Managers and support personnel
- Internal process owners who will be audited to the requirements of regulatory compliance
- Consultants
Phil Smart, is founding member of RA/QA International. He is an Auditor, Consultant and Instructor to 21 CFR Part 820, CMDR/CMDCAS, MDD, MHLW/PMDA/Japanese PAL. Phil has been a Notified Body Lead Assessor for over 15 years with over 450 3rd-party, 2nd-party, and internal audits of medical device manufacturers in the Americas, Europe, Japan and Southeast Asia.
More Training By Experts
- Internal Auditing of Risk Management: Emphasis on effectiveness and compliance to QSR, ISO 13485 and ISO 14971
- International GMP's for Medical Devices: Quality System requirements for USA, Europe, Canada and Japan
- Risk Management and Internal Auditing: Effective quality audits with inclusion of ISO 14971:2007
- GCP Audit of Clinical Evaluations for Japan: Requirements and expectations from the revised Japanese PAL
- Japan PAL Audits performed abroad by the PMDA: What to expect and how to prepare
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar 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).
