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


FDA issues final guidance on ICH Q10

April 9, 2009

The FDA has provided a model for implementing the ICH Q10 quality control system in its final guidance, which is intended help manufacturers adapt processes throughout a product’s lifecycle.

By building upon good manufacturing practices (GMP) the International Conference on Harmonization’s (ICH) Q10 attempts to provide a comprehensive model for an effective quality management system.

The implementation of aspects of ICH Q10 not covered by GMP is optional. However, by adopting the additional processes outlined in the US Food and Drug Administration’s (FDA) guidance manufacturers should benefit from the innovation and continual improvement that are central tenets of ICH Q10.

In addition unlike GMP ICH Q10 explicitly covers all aspects of a product’s lifecycle, from development through to discontinuation, and is designed to strengthen the link between pre- and post-commercialization manufacturing activities.

Within this framework the FDA identifies three main objectives: achieve product realisation, establish and maintain a state of control and facilitate continual improvement.

To achieve these goals the FDA recommends companies use knowledge and quality risk management, with the guidance detailing how these ICH Q10 “enablers” should be used.

The complete guidance can be found here .

Source: In-PharmaTechnologist.com