International GMP's for Medical Devices: Quality System requirements for USA, Europe, Canada and Japan
Instructor:
Phil Smart
Product ID: 700844
Areas Covered in the seminar:
- General QMS requirements for FDA, Canada, Europe and Japan: ISO 13485 as a platform.
- Focus on standards to demonstrate compliance. Examples include ISO 13485, ISO 14971, ISO 14644.
- Focus on process validation and the GHTF.
- Focus on facilities and environmental controls.
- Focus on Risk Management and ISO 14971.
- Focus on internal audits to cover regulatory requirements.
- Insight on external audits and what to expect from: FDA, Notified Body, CMDCAS Registrar, PMDA or JPAL 3rd party.
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:
- QA Managers and Personnel
- RA Managers and Support Staff
- Quality System Auditors
- Consultants
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.
More Training By Experts
- Internal Auditing of Risk Management: Emphasis on effectiveness and compliance to QSR, ISO 13485 and ISO 14971
- 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
- 4-Region internal audits: Medical Device Quality System audits that cover internal regulatory compliance for FDA, Europe, Canada and Japan
- Japan PAL Audits performed abroad by the PMDA: What to expect and how to prepare
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