OOS Test Results and Completing [Robust] Investigations

  • 150.00 Dollar US$
  • Published date: September 12, 2018
    • Fremont, California, United States

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

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