🎤  Meena Chettiar      |  📅  Recording Available   |  🕒  75 Minutes


After the final FDA approval and initiation of marketing of your medical devices, regulating bodies such as US FDA and other regulatory bodies send their inspectors on a periodic basis to device manufacturing facilities. Now, the new MDSAP, Medical Device Single Audit Program can reduce the frequency and length of these audits. This important and timely webinar will discuss the key preparation steps for MDSAP of your medical device manufacturing quality system. 

Why You Should Attend: 

Large and small medical device companies will have additional challenge in preparing for and dealing with audits under the current Tsunami of escalating medical device regulatory and global auditing requirements. Quality and Manufacturing personnel in charge of creating and maintaining your quality management system for all of the medical devices manufactured at your facility should be familiar with MDSAP auditing expectations. The fact is: that global regulatory expectations for medical devices are escalating. The bar has been raised a lot for MDSAP after ISO 13485: 2016 and introduction of the harmonization efforts by IMDRF (International Medical Device Regulatory Forum).

Areas Covered in the Session:

  • MDSAP Audit requirements as per USFDA, Health Canada, TGA, ANVISA, Japan’s PMDA
  • MDSAP quality and regulatory requirements for:
    • Management Controls
    • Product design Controls
    • Production and Process Controls
    • CAPA Subsystem
    • Sterilization Controls
  • GMP regulations to withstand a solid MDSAP scrutiny
  • Simplifying audit planning and execution
  • Specific areas auditors will examine and questions they will ask
  • How MDSAP compares to an ISO 13485: 2016, Canada’s CMDCAS and the US FDA’s 21 CFR 820 inspections
  • The MDSAP grading system and how nonconformance issues can be escalated
  • How risk assessment will play a major part in audits of this risk averse industry
  • How each of the five countries will implement MDSAP
  • The outlook for EU participation
  • Requirements unique to each participating country

Who Should Attend:

  • Research and Development Departments
  • Quality Assurance Departments
  • Quality Control Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Auditors, Audit Facilitators and Inspection Personnel
  • Engineering Departments
  • Operations Departments
  • Design Assurance Teams
  • Document Control Professionals

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