Investigating Out-of-Specification Test Results – 2013 Regulatory Requirements & The Latest Industry Trends

A Comprehensive 2-Part Live Webinar Training Program

Part 1: Wednesday October 09, 2013 Time 1:00pm to 3:00pm ET
Part 2: Wednesday October 30, 2013 Time 1:00pm to 3:00pm ET

Instructor: Jerry Lanese Ph.D., CMC.
Click Here to Register for the 2 Part Live Training Program

This exclusive, two-part live training program is designed to provide QC and QA personnel with an understanding of why the investigation of OOS results is important and as well as the best practices involved in an effective OOS Investigation.
The information will allow Quality Control personnel to develop programs and procedures that will result in effective and compliant investigations that will result in the identification of laboratory errors, effective retesting with determination of testing outliers.
It will provide Quality Assurance personnel with tools for the identification of the cause of deviations beyond the laboratory, and the application of the investigation to continuous process improvements. It will provide guidance for QA for the facilitation of investigations of confirmed OOS observations as well as discrepancies not associated with the laboratory.

Please scroll down for complete details of both parts of this exclusive live training program.

The objective of Part I of this interactive webinar series is to develop an understanding of the laboratory investigation of OOS test observations and explain how the laboratory interfaces with the Quality Unit through the laboratory investigation process. The discussion will be based on the FDA guidance in handling OOS laboratory results.

This live training webinar integrates the laboratory OOS investigation activities with information on the general requirements for investigations and the investigations beyond the laboratory discussed within Part I. It suggests procedural approaches to laboratory investigations in compliancy with the latest regulatory expectations.

The objective this interactive Tungsten Shield live webinar training is to provide a clear process for compliant laboratory OOS investigations.

This Live Presentation Will Cover (Part 1):
-The requirements for laboratory OOS investigations
-FDA Regulatory expectations
-The laboratory OOS investigation process
-Laboratory investigation, Phase I
-Laboratory investigation, Phase II
-Repeat testing
-Retesting
-Resampling
-Communicating with Quality Assurance

Learning Benefits:
-Understand of the developing expectation for appropriate OOS investigations
-Understand of the expectation for the identification of the cause of the OOS results
-Gain a clear insight of the laboratory OOS investigation process
-Learn the terminology associated with laboratory OOS investigations
-Learn about outlier testing
-Understand how the OOS laboratory investigation process relates to the general expectation for deviation investigations

Regulations and Guidances that will be covered (FDA, EU, Canada, WHO, ICH, other)
-US - 21CFR211.160, 192
-ICH Q7; 11.1
-Canada C02.015
-FDA Guidance for the Industry; Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production

Webinar outline and time breakdown:
Date: October 09, 2013 1pm ET

*Please note all times are Eastern Standard Time

Part 2 - Out-of-Specification (OOS) Investigations; General Considerations and Investigations Beyond the Laboratory
Live Interactive Training Webinar

Date: October 30, 2013
Time: 1:00pm - 3:00pm ET

Investigation of any discrepancy or deviation is and expectation of all regulatory agencies. This includes the follow-up of confirmed OOS laboratory observations. The US FDA has been very active in writing observations of inadequate investigations. The Quality unit is accountable for adequate investigations with appropriate, verified corrective and preventive actions. It must have systems which integrate the resources of all of the units of the organization that result in the investigation of deviations and discrepancies, identification of the cases and implementation of actions that result in process improvements.

The objective of Part II of this two part live Tungsten Shield training webinar program is clarify the expectation for deviation and discrepancy investigations and how the identification of the root cause of problematic areas with corrective and preventive actions supports the FDA emphasis on the continuous process improvement, which is the foundation of any Quality System.

This Live Presentation Will Cover (Part 2):
-A review of the requirements for the investigation of deviation and discrepancies
-The role of Quality in investigations
-Responsibilities of the other disciplines in the deviation investigation system
-Corrective actions
-Preventive actions
-The verification of corrective/preventive actions

Learning Benefits:
-The expectation for investigations with follow-up process improvements
-Investigation tools
-The roles of Quality and other units within the organization
-How investigations relate to other Quality System Elements

Regulations and Guidances that will be covered (FDA, EU, Canada, WHO, ICH, other)
-US - 21CFR211.160, 192
-ICH Q7; 11.1
-Canada C02.015
-FDA Guidance for the Industry; Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production

Webinar outline and time breakdown:
Date: October 30, 2013 1pm ET

*Please note all times are Eastern Standard Time

List of handout materials included with this training program:
-A Copy of the presentation slides
-A copy of the FDA guidance: Investigation of Out of Specification Test Results for Pharmaceutical Production

Who should attend:
The following individuals or disciplines will benefit from attending this training program:
-Quality Assurance personnel
-Quality Control personnel
-Research & Development
-Regulatory Affairs Professionals
-Auditors

Click Here to Register for the 2 Part Live Training Program>>>