Establishing Appropriate Quality Metrics and Key Performance Indicators

By: Kelly Thomas ,Vice President, Americas Quality Operations at Stallergenes Greer.

Importance of establishing metrics, how to distinguish Key Performance Indicators

  • 31-January-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

21st Century Cures Act -New Guidance on Medical Device Software Compliance

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

Waive the requirement for “informed consent” in specific cases

  • 24-January-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms

By: Roger Cowan ,Pharmaceutical Consultant, R Cowan Consulting Services LLC.

Cleanroom environment and its testing requirements according to international regulatory standards

  • 29-January-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes
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