Internal & External GMP Audits
Achieve quality assurance with effective audits! In the world of Good Manufacturing Practice (GMP), audits are an indispensable tool to ensure quality and encourage continuous improvement. This training provides practical tools to conduct audits efficiently and effectively - both internally within your own organization and externally with suppliers or during inspections.
Short Description
The course consists of a balanced combination of theory and practical training with specific focus on the various important issues that must be taken into account during the execution of an audit.
Why choose this training?
Practice-oriented: With realistic cases and role plays
Up-to-date: Based on the latest GMP guidelines and inspection findings
Experienced trainers: With extensive experience in both industry and auditing practice
Interactive: Room for questions, discussion and hands-on assignments
Average score for this course (Jan 2025): 9
Objectives
After attending this course, participants will have gained the following knowledge:
The purpose and importance of audits within a GMP environment
Differences and similarities between internal and external audits
Preparing, conducting and following up an audit
Practical techniques for interviewing, observing and documentation review
Dealing with deviations and preparing corrective actions (CAPA)
Preparing an audit report that complies with GMP requirements
What to expect during inspections by authorities such as IGJ or EMA
Target Group
This training is designed for quality assurance personnel, QA/QC specialists, auditors, production and laboratory managers, and anyone involved in GMP processes or conducting or preparing audits.
Program
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