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OOS Test Results and Completing (Robust) Investigations - Webinar

: 30 Nov 2018

Sector: Clinical, Pharmaceutical

Type: Conference, Training, Webinar


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

Venue


Organizer

Compliance4All
Phone: +1-800-447-9407
Email: support@compliance4All.com
Visit: http://www.compliance4all.com/control/main


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Stability Testing fo...
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Fundamentals of Asep...