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Site language : English - Français
Ref : 29361
Event :How to Conduct Annual Product Reviews to Achieve GMP Compliance

Date :Tuesday April 16th, 2019

Location :Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto, United States

Type :Conference & Seminar - International audience

Accreditation :--


 

Further information

Editorial

This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements as per US and Europe.
 

Objectives

  • Discuss how to write APRs
  • Outline the requirements for APR reporting
  • Review what information to include in the reports
  • Discuss how well written APRs benefit your firm’s compliance

Program

  • Annual Product Review definition
  • What needs to be included in the report
  • A model of an example Annual Product Review Report
  • Review of citations

Speakers

Danielle DeLucy

Danielle DeLucy
Owner, ASA Training and Consulting, LLC

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 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. Danielle 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, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.

 
 

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Location

Map and directions
Conference address :
Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto
United States
tel : +1-888-717-2436
Map and directions

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Details

How to Conduct Annual Product Reviews to Achieve GMP Compliance Hospital - Management
annual product quality review, apr, annual product review report, apr reporting, pharmaceutical product, documentation
Professionals, Site Quality Operations Managers Quality Assurance personnel Plant Managers and Supervisors Manufacturing Superintendents and Managers Regulatory Affairs Managers
10 -- --
English

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