Prepare for International Audits

Detailed exploration of the specific requirements set forth in the FDA's 21 CFR Part 820 for medical devices.

Detailed guidance on how to apply Good Manufacturing Practice standards to ensure regulatory compliance.

Development of skills to create and maintain accurate documentation, essential to meet regulatory requirements.

Deepening the management of risks associated with the production of medical devices and the importance of product safety.

Comprehensive preparation to face regulatory audits and inspections, understanding how to respond and prepare for these assessments.

Use of real case studies to exemplify and apply the concepts learned in the context of the medical device industry.

Comprehensive details on Canada's specific regulatory requirements for medical devices, including the guidelines, standards and compliance processes established by SOR/98-282.

Detailed exploration of the fundamental principles and structure of Canadian legislation governing the development, manufacture and marketing of medical devices.

Practical guidance on how to effectively implement and comply with Canadian regulatory requirements in the development, production and distribution of medical devices.

Connection between Canadian regulations and international standards established by the International Medical Device Regulatory Forum (IMDRF), understanding how these standards influence Canadian requirements.

Details of conformity assessment processes, including the certification of medical devices, the criteria required for approval in the Canadian market, and the procedures to maintain compliance throughout the product life cycle.

Strategic guidance to effectively navigate Canada's medical device market, addressing best practices, common challenges, and opportunities to ensure commercial success.

Understanding of Japan's regulatory framework for medical devices, including the role and responsibilities of the MHLW and PMDA.

Specific details on the requirements set out in MHLW Ordinance 169, including the guidelines for registration, manufacturing and marketing of medical devices in Japan.

Exploration of the medical device registration process in Japan, covering the necessary documents, deadlines, steps and requirements for approval.

Understanding of quality standards required in Japan for medical devices, aligned with international standards and local expectations.

Discussion of post-market responsibilities, including adverse event reporting, recalls and corrective actions in the Japanese market.

Identification of key challenges faced by companies in complying with Japanese regulatory requirements and strategies to ensure ongoing compliance.

Detailed understanding of the requirements established by the TGA and ARGMD for the approval and commercialization of medical devices in their respective markets.

Knowledge of the specific process for registering and submitting medical devices to the TGA and ARGMD, including the necessary documentation and deadlines involved.

Understanding the quality and safety standards required by these regulatory agencies, addressing technical and manufacturing aspects to ensure compliance.

Exploration of Good Manufacturing Practice (GMP) guidelines and requirements established by the TGA and ARGMD, ensuring the safe and consistent production of medical devices.

Knowledge of the practices and procedures involved in inspections and audits conducted by the TGA and ARGMD to assess the compliance of manufacturers and processes.

Development of effective strategies to ensure ongoing compliance with TGA and ARGMD regulatory requirements, including change management and regulatory updates.