Medical Device Webinars / trainings @$149 (On-Demand)

July 23, 2009

Are you looking for online training for Medical Device Industries and Life Sciences?  What all it has –

  • 60 minutes of online training
  • Convenient access anytime, anywhere
  • A great way to meet your educational needs
  • Courses for the Life Sciences and Medical Device Industries

Check out here –

  1. Basic Requirements for Steam Sterilizer Validation per ISO 17665
  2. Best Practices for Managing FDA Investigators and Handling FDA 483 Observations
  3. Medical Device Complaints, MDR’s and Recalls
  4. Six Sigma Methodology for Process Validation
  5. Documenting a Risk-Based Quality System – for Compliance and Cost-Savings
  6. How to perform effective supplier audits, and avoid FDA 483’s and Warning letters
  7. Verification vs. Validation in Regulated Industries
  8. CAPA Essentials – core principles and practices needed to implement an effective and efficient CAPA process
  9. Introduction to Process Capability (Cp, CpK, Pp, Ppk)
  10. How to Use the System Risk Level to Save Time and Money on Computer System Validations
  11. Implementing the new International and FDA accepted Software Development Standard IEC 62304
  12. Risk Management Activities during Design Input
  13. Developing a Robust CAPA System
  14. Complying with 21CFR Part 11-Understanding the Role of Predicate Rules
  15. The New Dietary Supplement Good Manufacturing Practices
  16. Configuration Management and Change Control for Computer Systems
  17. Cleanroom Operation, Maintenance and Operators
  18. Conducting and Documenting Proper Risk Analysis In compliance with ISO 14971
  19. 510(k) Preparation for a Small to Medium-Sized Company
  20. Applying Lean Documents to a Project – how to create a project file, follow design controls, yet maintain a lean set of project documents.
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Medical Device training / webinars

April 29, 2009

Check out for medical device trainings/webinars

1. Process Validation for Medical Device Manufacturers

This Process validation training will discuss the CDRH interpretation of the GHTF guidance and how manufacturers should develop Process Validation Plans and conduct production Process Validation.

2. Risk Analysis and Human Factors Engineering

The Risk analysis training will incorporates these techniques into the overall product lifecycle using the principles of ISO 14971 and how to develop an integrated program incorporating risk analysis and human factors engineering.

3. Basic Requirements for Steam Sterilizer Validation per ISO 17665

This Steam Sterilization training will review the general requirements for performing a steam sterilizer validation via the “overkill” half-cycle method as described in ISO 17665 (supersedes ISO 11134).

4. Japan – Regulatory Filing Requirements and Compliance Processes for Life Sciences PART II

This Regulatory compliance training is designed to provide an overview of the regulatory environment in Japan.

5. A Case Study in Equipment / Process Software Verification and Validation

This FDA compliance Training will guide through the models simplifies regulatory requirements for equipment software V&VT, assuring key FDA requirements are not overlooked. QMS and 21 CFR Part 11 require yet another approach.

6. Japanese PAL – JPAL QMS requirements in Ordinance 169 and differences to ISO 13485

This JPAL (Japanese Pharmaceutical Affairs Law) QMS will explore, in detail, the QMS requirements placed on the foreign manufacturer via Ministerial Ordinance 169, Ordinance 2 and Ordinance 179.

Source: ComplianceOnline


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