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OOS Test Results and Completing [Robust] Investigations


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Who should attend?

Regulatory Affairs GMP Auditors Quality control and Quality Assurance Personnel responsible for Generating or Evaluating test results in a regulated Environment Consultants Training Departments

Details

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

Prices

One Dial-in One Attendee Price: $150.00

Contact

Event Manager
support@compliance4all.com

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