How to Conduct Annual Product Reviews to Achieve GMP Compliance Annual


Danielle DeLucy, MS, is Keynote speaker at ComplianceKey. She 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 Microbiolo........

Overview

Annual Product Quality Review (APR) is an evaluation conducted annually to determine if there are any possible changes in the process or manufacturing of the pharmaceutical product or any change in the specifications of the product or any change in the manufacturing process. It is designed to minimize the product defects and also the risks associated with the manufacturing of the pharmaceutical product.

Why should you attend this webinar?

This webinar will discuss the comparative evaluation about similarities and differences of requirements associated with the manufacturing of the drug product in different countries. It is also necessary to know that the regulatory requirements of different countries are different and hence this will further guarantee the quality of the pharmaceutical product.

Areas Covered in the Session:

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

Who can Benefit:

  • Quality Assurance
  • Quality Control Directors
  • Managers
  • Specialists 
  • Regulatory Affairs
  • Regulatory Compliance Directors
  • Engineering
  • Development Directors


Webinar Id: LSHCDD008

Training Options:

Duration: 60 mins

  07-Apr-2020

 12:30 PM PT | 03:30 PM ET

 Single Attendee: [Only for one participant]

$199 (Live)                    $353 (Live + Recorded)

 Multiple Attendee: [For a group of 2-5 participants]

$463 (Live)                    $865 (Live + Recorded)

 Corporate Attendee: [For a group of 6-10 Participants]

$936 (Live)                    $1388 (Live + Recorded)

 Recorded: [Six month unlimited access]

$267 (Single Attendee) $549 (Unlimited Attendee)

Refund Policy
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