Hazard Analysis / Risk Management is a required in device development, validation, CAPA investigations / resolutions, and most other cGMP considerations. Both the U.S. FDA and the EU’s MDD/MDR require companies to be proactive in reducing product risk while increasing user benefits. What “risk” is to be analyzed? One of the best tools to achieve and document this is ISO 14971 for devices. Recently ISO 14971 was changed. The 2019 version is replacing the 2014. What does that mean for medical device designers, specification developers, manufacturers, QA and RA? How should the change be managed? Common considerations: Many cGMP activities must be “Risk-Based”. What does that mean; what does it not mean? – An important distinction, which, when neglected, has resulted in several Warning Letters from the US FDA. How does ISO 14971 address risk-based. How is it mandated to be used in software verification and validation. How does it impact CAPA / NCMR / Complaint investigations. Many firms use some product risk management tools, but are not compliant to ISO 14971 in any version, for devices. What changes would be necessary to become compliant? What are Europe and U.S. regulatory expectations? What benefits beside regulatory compliance can be achieved for a company? Why You Should Attend: In this important webinar, see the elements recommended or expected to be in the Risk Management File / Report. Learn how to blend ISO 14971 into a company’s cGMP system, which is a requirement of regulatory agencies. What should be the areas of focus. Make the document a “living” document. Achieve major business benefits by regular use of the Risk Management File / Report in training, marketing, validation, root cause analysis, CAPA activities and failure investigations, as well as the obvious, increased product safety and reduced liability. Areas Covered in the Session : The Changes; Timelines Key Requirements of ISO 14971 Suggested formats Expected sources of information to evaluate What to include How to complete, document, and control Areas of contraversy An often neglected safety feature A “living” useful, cost-saving document Is it being used to its full business benefit? Who Should Attend: Quality Assurance Departments Research and Development Departments Regulatory Affairs Departments Manufacturing Departments Engineering Departments Operations Departments Production Departments Validation Departments Documentation Departments Consultants


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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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