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FDA Process Analytical Method Validation
Date
Mar 11, 2021 - 10:00 AM
Link to Website
Organizer
Netzealous LLC DBA - Compliance4All
Venue
online
Location
161 Mission Falls Lane, Suite 216,,
Mission Falls Ln
Fremont,
California,
United States,
ZIP: 94539
Phone: 8004479407
Ticket Price: One Dial-in One Attendee Price: $150.00
Overview:
An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry.
Why should you Attend:
Observations that test methods are inadequate or the firm does not have appropriate data that demonstrates the method performs as intended rank high on the list of observations in the laboratory.
Areas Covered in the Session:
FDA System Based Inspection Guidance
Laboratory Control System
Most common observations in the laboratory
Warning letter observations and analysis
Who Will Benefit:
Quality Control Manager
Supervisors
Analysis and Microbiologists
Speaker Profile:
John (Jerry) Lanese is an independent consultant with a focus on Laboratory Controls, Quality Systems and the components of an effective Quality System as they apply to the pharmaceutical and medical device industries and their suppliers to those industries. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan.
Event Fee: One Dial-in One Attendee Price: US$150.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]
An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry.
Why should you Attend:
Observations that test methods are inadequate or the firm does not have appropriate data that demonstrates the method performs as intended rank high on the list of observations in the laboratory.
Areas Covered in the Session:
FDA System Based Inspection Guidance
Laboratory Control System
Most common observations in the laboratory
Warning letter observations and analysis
Who Will Benefit:
Quality Control Manager
Supervisors
Analysis and Microbiologists
Speaker Profile:
John (Jerry) Lanese is an independent consultant with a focus on Laboratory Controls, Quality Systems and the components of an effective Quality System as they apply to the pharmaceutical and medical device industries and their suppliers to those industries. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan.
Event Fee: One Dial-in One Attendee Price: US$150.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]
Event Categories
Keywords: Educational, FDA, medical
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