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Site language : English - Français
Ref : 28075
Event :OOS Test Results and Completing [Robust] Investigations

Date :Friday November 30th, 2018

Location :Online (Internet, Videoconferencing, ...)

Type :Education - International audience

Accreditation :--


 

Further information

Overview:
This training program will describe when a full investigation should be triggered and the frequency for re-testing and re-sampling. Attendees will also learn how to implement corrective and preventive action plans (CAPA).
 
Why should you Attend:
This 90-minute accredited course is designed to provide sound training on how to recognize and investigate atypical or out of specification results, using approaches which have been recommended by regulatory authorities, performing appropriate investigations.
 
Areas Covered in the Session:
Developing a Proper CAPA Plan to Address Any Corrective Actions
How to Properly Document Findings
Example of a Proper OOS Investigation Write Up
 
Who Will Benefit:
Lab Analysts
Supervisors and Managers in Pharmaceutical or Biological Laboratories
Regulatory Affairs
GMP Auditors
Consultants
Training Departments
 
Speaker Profile:
Danielle DeLucy MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 17 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations
 
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

Further information

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Announcer

Compliance4All
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 [...]

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Details

OOS Test Results and Completing [Robust] Investigations Medicine - Pharmacy - Bio-Technologies - Computer science
education, training, medical conference, online learning
Everyone, Review of the FDA Guidance for Industry on Investigating OOS Test Results Phase I: Initial Laboratory Investigation Phase II: Full Scale Investigation Root Cause Analysis Methods
50 1 --
English

Other

For more information on OOS Test Results and Completing [Robust] Investigations, plsase contactr Compliance4All

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