FDA Process Analytical Method Validation

Start Date : February 9, 2018
End Date : March 9, 2018
Time : 10:00 am to11:30 am

Phone : 8004479407
Email : support@compliance4All.com

Description

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: support@compliance4All.com

Organized by

Organized by compliance4all14

Event Manager ,
161 Mission Falls Lane, Suite 216,

Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. 

 

Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.

Tel: 800-447-9407
Mobile: 8004479407
Email: support@compliance4All.com
Website: http://www.compliance4all.com/


Event Categories: Health & Nutrition.

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