Topic : How to Conduct Annual Product Reviews to Achieve GMP Compliance Annual

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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

Speaker Profile :

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.


Contact Info :

Compliance Key

Phone : +1 717-208-8666