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