Webinar On "Deviations and Investigations FDA Observations and How To Avoid Them"

Event Details

Time: September 21, 2017 from 1pm to 2:30pm
Location: Online
Street: 9106 Seven Locks Road
City/Town: Bethesda
Website or Map: http://bit.ly/2gJFFxo
Phone: 1-844-216-5230
Event Type: online, webinar
Organized By: Sam Miller
Latest Activity: Sep 18, 2017

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Event Description

Description :

The GMPs require that the pharmaceutical firm complete and report an investigation of any product or process deviation or discrepancy and the FDA reviews investigations in depth in most site inspections. As a result, inadequate investigation is high on the list of FDA observations. Pharmaceutical firms either do not understand the expectation for, and value of, a thorough, timely investigation, or are not willing to commit the resources to appropriate investigations. In this webinar we will discuss the importance of and regulatory expectation for thorough, timely investigations and some of the tools that might be used during the investigation of a deviation.

Objective :

The objective of this webinar is to enlighten the participants about the need to conduct adequate investigations of deviations and follow through with appropriate and timely corrective and preventive actions.

Areas Covered in the Session :

The discussion will include the following:

Regulations that require deviation investigations
Guidance that supports the FDA expectation for deviation investigatons
Observation that support the FDA focus on the investigation of deviations
Sources of deviations
Tools that should be considered to support deviation investigations
Suggestions for organizing for deviation investigations

Who Will Benefit:

The following individuals should attend this audio seminar:

Senior Management
Quality Directors
Quality Managers
Quality Reviewers
Directors of all disciplines within operations
Managers of all disciplines within operations

About Speaker:

John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. Dr. Lanese moved from the academic environment to the pharmaceutical industry where he has managed Analytical Research, Quality Control and Quality Assurance functions.