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 webinar/training

April 9, 2009

Here is the updated list of few upcoming webinar on medical device –

  1. The EU Clinical Trial Directive
  2. Preparing and Executing Medical Device Quality Audits: How to Meet the FDA’s Expectations
  3. Gamma Sterilizer Validation: Method 1 and VDmax25 per ISO 11137
  4. Risk Management – Do Not Throw Dice on Your Company!
  5. Maintaining a Sustainable and Compliant Design Validation System and Using FMEA for Device Manufacturers
  6. Risk and Hazard Assessment for Medical Devices – ISO 14971
  7. New Medical Device Vigilance Guidelines

Source: ComplianceOnline