GMP Good Manufacturing Practice written in a notebook on white table Set to talk about a holistic approach towards remediation of non-compliances and 483s, the event will take place on June 15, 2019
Quality Solutions is organising the third edition of GMP Workshop that will take place in Mumbai on June 15, 2019 and will focus on how to handle 483s and FDA warning letter, while also understanding the differences in approaches of US FDA, EU and other regulators.
Also talking about the importance of team handling inspection, there will be discussion on most frequent categories of 2017 and 2018 across world, laboratory-related 483s and importance of computer validation, understanding inspection and prepare for it as expected by FDA. It will also focus on how to define tasks and assigning personnel to specific tasks for the inspection, facility requirements to support the inspection (front room, back room), the value of mock audits, how personnel should conduct themselves during the inspection and the inspection process and the process of dealing with all other audit non-compliances, and mindset of investigation at department head level.
The topics of learning at the workshop are as follows:
- Review of 2017 and 2018 483s
- Laboratory-related 483s and NCs
- Computer/software system validation
- Data storage, archival and data integrity
- Challenges in software execution and its long-term benefits
- Importance of inspection management skills
- Building quality culture for all time readiness
- Importance of human aspect in inspection and during remediation
- Remediation approach for 483 Vs EU and other countries
The beneficiaries include those who are supposed to face audit and are involved in preparing replies, quality/ regulatory management, corporate QA management, manufacturing management, QC management and IT/ engineering management.