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Course offering number:0806-208
Course ID:
2200
DQ: A Guide to Protecting Your Interests When Procuring Sensors
June 10, 2008 at 11:00 a.m. - 12:30 p.m. (EST–New York time)
AN ONLINE TRAINING FORMAT
Who Should Attend
This course outlines a detailed plan for working with sensor, monitor and instrument vendors; especially system
integrators that customize analytical instruments. DQ, or Development Qualification, helps PAT and QbD
managers to specify, acquire and deploy “good-science” monitoring in pharmaceutical manufacturing. It is recommended for:-
PAT Team managers and members
- QbD implementers
- Quality Risk Managers
- Analytical method developers for process improvement
- PAT-oriented regulatory affairs personnel
- Instrument procurement personnel
Description
This comprehensive 90-minute online training course provides strategies for prioritizing and selecting PAT/QbD sensors, a ranking system to aid in risk/reward judgment and guidelines for establishing a Scope of Work document that will protect your program requirements. Successful completion will help forestall “gray areas” in procurement, delivery and acceptance.
Module 1:
Matching instruments with Critical-to-Quality attributes
Selecting instruments to ensure "Desired State"
Rating instrumental technologies for manufacturing use
Critical software issues
Module 2:
The Attribute & Application Hexagon
Does customization make sense?
DQ and the Scope of Work document
Milestones and timetables for procurement
Module 3:
Incorporating IQ, OQ and PQ into procurement
Regulatory considerations
Sensor redundancy
Instrument and test acceptance