Batch Record Review and Release Seminar in the Pharmaceutical Industry – Coming Soon January 2026

Gstudy > Courses and seminars > Batch Record Review and Release Seminar in the Pharmaceutical Industry – Coming Soon January 2026

By Rina Harari, B.Sc

1.0

Quality Assurance

Audits

Location: Online

Starts at: 09:30

Duration: 1 Session

Language: Hebrew

Course Description:

A seminar designed to provide Quality Assurance professionals with essential tools for reviewing product batch records prior to final release by the Qualified Person (QP) or other authorized personnel responsible for product release. The training emphasizes critical GMP principles including: signatures and documentation, corrections and amendments, handling of instrument printouts, and batch record organization. The program includes comprehensive review of regulatory requirements, Data Integrity principles, and product release processes with emphasis on practical implementation and current industry tools. 

Learning Outcomes:

  • Competency to perform professional and independent batch record reviews
  • In-depth understanding of regulatory requirements and their practical implementation
  • Mastery of Data Integrity principles and their application
  • Practical tools for problem identification and resolution
  • Participants will gain solid foundation for interfacing with health authorities
   

Target Audience: Pharmaceutical industry professionals, graduates in medical laboratory sciences, chemistry, biotechnology; QA/QC personnel; engineers; healthcare project managers

Prerequisites: Relevant educational background (medical laboratory sciences, chemistry, biology, biomedical engineering) or industry experience. Basic familiarity with GMP environment preferred.

 
  • About Rina Harari, B.Sc

    Rina Harari is a Quality Assurance Project Manager with extensive expertise in sterile production, aseptic manufacturing, and GMP compliance. She has more than a decade of experience in the pharmaceutical and biotechnology industries, including senior QA positions at Gamida-Cell, Ayana Pharma, and Rafa Laboratories. Her expertise covers preparation for FDA and Ministry of Health inspections, management of deviations and CAPAs,...

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