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OOS Test Results and Completing [Robust] Investigations

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Category OOS Test Results, CAPA Trainings, capa training courses, corrective and preventive action training, technical training courses, capa software, fda capa training

Deadline: November 28, 2018 | Date: November 30, 2018

Venue/Country: Online, U.S.A

Updated: 2018-09-07 15:36:43 (GMT+9)

Call For Papers - CFP


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


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


Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.