FDA Process Analytical Method Validation

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Category Analytical Method Validation, laboratory Trainings, laboratory information system, Online management courses, laboratory management and safety, fda calibration guidance

Deadline: March 08, 2018 | Date: March 09, 2018

Venue/Country: Online, U.S.A

Updated: 2018-01-30 16:16:44 (GMT+9)

Call For Papers - CFP

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: supportcompliance4All.com