ROGER COWAN


CMO Supplier Quality Agreements - How to Comply with new FDA and EU Guidelines for Contract Drug Manufacture
CMO Supplier Quality Agreements - How to Comply with new FDA and EU Guidelines for Contract Drug Manufacture
: Roger Cowan
Recorded Webinar

A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety, and efficacy of the manufactured drug. Recently, the EU and the FDA issued regulatory guidance to bring some clarity and consistency to these quality contracts:EU GMP Chapter 7 "Outsourced Activities" January 2013Guidance for Industry -.....

$200.00
GMP Environmental Monitoring for Pharmaceutical Clean Rooms
GMP Environmental Monitoring for Pharmaceutical Clean Rooms
: Roger Cowan
: 11 January 2019
: 01 : 00 PM EST
: 60 Minutes

Environmental Monitoring looks at the end results of the Environmental Control program – the microbiological and particulate quality of the clean room. As the FDA Guideline on Aseptic Processing GMP (2004) states: “In aseptic processing, one of the most important laboratory controls is the environmental monitoring program. This program provides meaningful information on the quality of the aseptic processing.....

$179.00
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