This webinar is intended to help you get familiar with medical device laws and regulations in Asian countries: China, India, Japan, and Korea. The medical devices are currently one of the fastest growing industries. The current knowledge and accurate understanding and adequate interpretation of global medical device laws, regulations and regulatory requirements have become increasingly important in our competitive global market. Global regulations of medical devices are rapidly evolving, which necessitates the integration of regulatory schemes available and applicable in various regions of the world to best develop a practical, actionable and sustainable regulatory plan and strategy. For many reasons, Asian medical device markets are highly attractive. Thus, it is imperative we get familiar with currently applicable and relevant laws and regulations governing medical devices, further streamlining the regulatory process. In this webinar, the speaker will discuss the updated differences in regulatory frameworks (regulatory requirements and compliance) in Asia, intending to help you understand and accurately interpret applicable laws and regulations governing medical devices in China, India, Japan and Korea. This webinar will help you expedite the registration process for your devices in these Asian countries. Speaker will present laws and regulations governing medical devices in China, India, Japan and Korea. It is designed to help medical device industry implement practical, actionable and sustainable strategy for device registration in these countries and further to streamline their business planning and registration process in Asian countries. Areas Covered in the Session : Updated medical device laws and regulations in China, India, Japan and Korea. Definitions, Device classification and rules Regulatory framework for medical devices in China, India, Japan and Korea. Regulatory requirements for medical devices including in vitro diagnostic devices in China, India, Japan and Korea. How to identify and address the regulatory requirements How to establish and maintain systematic methods to meet the regulatory requirements. How to streamline the regulatory process. PASS-IT Recommendations: Best Practices Interactive Q&A session Who Should Attend: Regulatory Affairs Managers, Directors and VPs Clinical Affairs Managers, Directors and VPs Quality Managers, Directors and VPs Quality Managers, Directors and VPs Compliance Managers and Directors Sales and Marketing Managers, Directors, and VPs Complaint Handling and Risk Management Managers and Directors Site Managers, Directors, and Consultants Senior and Executive Management Compliance Officers and Legal Counsel Business Development Managers, Directors, and VPs


$350 

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Areas Covered in the Session :

  • Review the current regulatory requirements and guidances (CFR, EU GMPs, ISO, etc.) for environmental monitoring.
  • Discuss issues of sampling methods, selection of sampling sites and the justifications for them.
  • Review the issue of contamination control as an important aspect of EM programs.
  • Discuss the issue of action and alert limits, trending of data and the handling of excursions.
  • What are the most common deficiencies cited by regulatory auditors when auditing environmental monitoring programs?
  • Attendee question and answer period.

Who Should Attend:

  • QA/QC Teams
  • Manufacturing Teams
  • Engineering Teams
  • Validation Teams
  • Regulatory affairs Teams
  • Management Teams
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