Handling OOS Test Results and Completing Robust Investigations

December 07, 2015

CfPA-The Center for Professional Advancement, 90 Minute Accredited Online Training
January 27, 2016 at 11:00 a.m.–12:30 p.m. (ET)

Who Should Attend?
This course is intended for professionals in the pharmaceutical and biological industries.

It will be especially valuable for the Lab Analysts, Supervisors and Managers in Pharmaceutical or Biological Laboratories, including Quality Control and Quality Assurance Personnel responsible for generating or evaluating test results in a regulated environment.

Course Description

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.

Organized by:

CfPA-The Center for Professional Advancement

Invited Speakers:

Danielle DeLucy, MS; Independent Consultant to the Biologics and Pharmaceutical Industries

Danielle DeLucy, MS, is currently an Independent Consultant to the Biologics and Pharmaceutical Industries specializing in the areas of Quality Assurance and Quality Systems. Prior to this role, Ms. DeLucy has been in the industry for 15 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. Ms. DeLucy began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Ms. DeLucy assists companies who are faced with warning letters and consent decrees establish more robust quality systems so that the company can succeed.

Deadline for Abstracts:

n/a

Registration:

Please click here for registration information.

E-mail:

sberg@cfpa.com

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