Upcoming Medical Device webinars

August 12, 2008

I found a website where good number of webinars are available across Medical Device, Pharma, HR, Healthcare, right now I am listing medical device related webinars here but for further areas please refer ComplianceOnline.

  1. Process Mapping – Risk-Based P&PC
  2. Bullet-Proof CAPA
  3. Management Controls Under QSR and ISO 13485
  4. Introduction to Process Capability (Cp, CpK, Pp, Ppk)
  5. Successful 510(k) Submissions
  6. Designing an Effective Cleaning and Disinfection Program for Pharmaceutical, Biotech, and Medical Device Cleanrooms
  7. The Gateway: A Risk-Based Filter for Effective CAPA Management
  8. Design and Process FMEA Concepts
  9. Using HACCP Quality Plans to Improve Medical Device Compliance Outcomes
  10. Basic Requirements for Steam Sterilizer Validation per ISO 17665
  11. The Rapidly Emerging Field of FDA Safety Science:Its Impact on Regulatory Affairs, Quality Systems and Company Profitability
  12. Internal Auditor Training for ISO 13485 Auditors
  13. Understanding ISO 13485 vs. ISO 9001 for Successful QMS in Medical Device Industries
  14. Preparing for a U.S. FDA Audit
  15. Regulatory Requirements for Personnel Training to Assure QSR and ISO Compliance
  16. Managing Risk at the R&D–Manufacturing Interface
  17. The Road to FDA Approval: Advisory Committee Survival Strategies
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About ISO 13485

July 17, 2008

ISO 13485:2003 Certification is recognized as a worldwide quality certification specific to the Medical Device industry. According the International Organization for Standardization, “ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements applicable to medical devices and related services.”

The ISO certification as well as a successfully reviewed Technical File is required for a company to sell any medical device in the European Union and Canada.

ISO 13485:2003 – Requirements

  • Establishment of a quality management system for medical devices. A manufacturer must have quality procedures that are documented, controlled, and effectively implemented and maintained.
  • Ensuring that personnel have the right experience, education, training, and skills. Acceptable levels of competence must be defined. Training needs must be established and assessed. A record of competence must be maintained.
  • A detailed plan on how remedial processes will be used to assure conformity.
  • Planning and performance of regular internal audits.
  • Creating a procedure to gather feedback from customers and a feedback system to monitor emerging problems.

To understand the key success factors for risk based verification and validation planning to meet FDA and ISO 13485 requirements, Risk evaluation and development of mitigation strategies
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ISO 13485: Auditor Training

Conducting internal audits is a large part of maintaining compliance. Training internal auditors with specialized, on-demand methods tailored to the working environment of the medical device industry is thus essential. The right auditor training for ISO 13485:2003 should focus on:

  • How to document audits and auditor interpretations
  • How to prepare checklists
  • Listening and questioning techniques
  • How to prepare Nonconformance reports
  • How to write reports

To get more familiar with the requirements of the ISO 9001:2000 quality management system standard; as well as insights useful to internal auditors in companies establishing, maintaining, or implementing and Quality Management System (QMS),  Risk evaluation and development of mitigation strategies
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