MHPM H P C O N S U L T A N T S, L L C
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MHPM H P C O N S U L T A N T S, L L C
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Title:
HPLC Fundamentals-Operating in a Compliant Environment Description:
The scope of this workshop includes HPLC fundamentals, instrument
“readiness”, analyst responsibility and their linkage on data integrity. Length:
1 day Audience:
All
personnel
involved in daily instrument operation, laboratory managers, quality
assurance/control personnel. Learning Objectives:
·
General understanding of the fundamentals of high-pressure liquid
chromatography to: o
Provide insight on “what to look for” prior to initiating an
analysis o
Prevent unplanned events §
Out-of-Specification test results §
Laboratory Deviations o
Ensure data integrity Content Outline: Day
1 of 1 Morning
Session I.
Introduction II.
Preventing Deviations III.
Preventive Maintenance A.
Impact on day to day operation and data integrity IV.
Analyst Responsibility A.
Key Points to Consider Prior to Analysis a.
Test Method b.
Instrument Overview c.
Instrument Readiness d.
Instrument/Method/Calibration Setup B.
Key Points to Consider During Analysis a.
Equilibration and Injection Carryover b.
System Suitability Requirements
i.
Purpose c.
Automated Sequences – Unmanned Systems
i.
What to do to ensure system is operating within acceptable criteria C.
Key Points to Consider After Analysis a.
Data b.
OOS/Atypical c.
Reprocessing of Data d.
Documentation V.
HPLC Technical Overview/Relationship to data integrity A.
Pump B.
Auto sampler C.
Variable Wavelength Detector D.
Diode Array Detector E.
Electrochemical Detector F.
Refractive Index Detector Afternoon
Session VI.
Breakout Session A.
Applying Instrument Assessment Techniques B.
Preventing Unplanned Events/Actions Taken a.
System Suitability Failures b.
Instrument Shutdown c.
Leaks/Blockages d.
Error Messages e.
Evaluation of Chromatograms C.
Data Impact D.
Open Discussion |