Validation of GC / GC-MS Methodologies
Instructor:
John Fetzer
Product ID: 705259
- Duration: 60 Min
Why Should You Attend:
Instrumental gas chromatography is widely used to determine purity, the impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of the instrumentation and other associated items of column, solvents, and other reagents and chemicals is also an area of focus in an audit.
This presentation will cover the key elements to have a compliant method.
Areas Covered in the Webinar:
- The Injector
- The Column
- The Detection System
- The Data System
- Linearity
- Selectivity, Interferences, and Specificity
- Solution Stability
- Monitoring Performance
Who Will Benefit:
- Chemist
- Laboratory Assistants
- QA Managers and Personnel
- QC Managers and Personnel
- Validation Specialists
- Quality System Auditors
- Regulatory Compliance Associates
John Fetzer
Consultant, Fetzpahs Consulting
John C. Fetzer, has had over 30 year experience in HPLC methods development. He has authored or co-authored over 50 peer-reviewed papers on liquid chromatography, has served on the editorial advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bio analytical Chemistry.
Topic Background:
Instrumental gas chromatography, either as GC or GC-MS, are common techniques in laboratories that do regulatory-compliance work. For Good Laboratory Practice (GLP) or for ISO 17025 compliance, such methods must meet certain requirements.
In order to meet US EPA or FDA requirements, a method must meet many stringent regulatory requirements. The more important of these for specific analytical methods are method validation and instrument validation.
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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
