GMP Investigations and Problem Solving

Summary

This 3-day training provides a structured overview of GMP Investigations and Problem Solving relevant for finished dosage forms as well as API manufacturers. The course will help the participants overcoming the problems in QA and QC by practical tips and real-life examples including the following areas:
• Deviations
• Complaints
• Returns
• Recalls
• Out of Specification Investigations OOS
• Sterility test failures
• Aseptic Process Simulation failures
• Environmental monitoring failures and adverse trends

Who should attend?

• QC/QA specialists & officers
• Regulatory affairs
• Quality & Validation engineers
• Process validation specialists
• Microbiology specialists
• Design Engineers
• Engineering Production
• R&D Managers

Learning Objectives

• The expectations from the EU GMPs in respect of investigations is referenced in the Chapter 1. of the GMPs Pharmaceutical Quality System.
• The role of corrective actions and/or preventative actions (CAPAs) in identifying and resolving the deficiency investigation.
• The types of techniques to be employed during the investigation process with advantages and disadvantages for the different types of failure investigations.
• Understand that the use of risk assessments to reach appropriate decisions should be based on evidence, not opinions.
• Findings should not be biased to enable batch release decisions but to come to the correct GMP decision whether this is batch rejection or not.

Key Topics

• Regulatory expectations in respect of GMP/GDP Investigations
• Competent Authority Comments on investigation deficiencies
• The role of Effective investigations including types of tools to be used
• Problem Solving
• Risk Assessment

Online training experience includes

• Our client zone – a single source for all training materials as well as pre and post-training communication
• Live interactive format via the Zoom platform
• Direct interaction with the trainer and other participants
• Q&As, case studies, polls
• Training in digital format
• Digital and LinkedIn certificates