PTI - international

This introductory to intermediate-level course is designed for those responsible for operations and processes of batch record reviews and investigations within the Pharmaceutical and Biotechnology industries. It is intended for those with limited experience reviewing batch records as well as for those with some experience who want to review their approach and improve their skill sets. Persons within a managerial capacity are encouraged to attend to familiarize themselves with the overall processes necessary to comply with FDA and GMP requirements. Specifically, the following professionals, who need to gain a fundamental understanding of batch record review and investigation processes, would most benefit from the course:

•  QA Specialists/Managers/Associates
• Document Control Specialists
• Production Supervisors
• Validation Engineers
• Product Disposition Specialists
• QA Auditors
• Quality Coordinators
• Team Leaders
• Manufacturing Associates
• Compliance Specialists/Coordinators
• Documentation Specialists/Coordinators/Supervisors