Understanding Annex 13 Training - Industrial Technology Systems Ltd

Course Title:	Understanding Annex 13 Training
Course Duration:	1 day
Course Aims:	This course aims to provide an understanding of the Annex 13 guideline and an update from the previous version.
Course Content:	The principles and purpose of the annex Why and what? Terms and definitions Included within a glossary What system to use? Quality Management requirements Resource requirements People and training Premises and equipment Documentation - Creating a product using Instructions, specifications and procedures Including process and packaging instructions Process testing and batch records Production Materials and operations Comparator products, blinding and code breaks Packaging Handling and labelling requirements Quality Control Sampling Release requirements and release of batches QP responsibilities Shipping Quality Assurance for Complaints Recalls and returns Destruction of unused/returned products Potential problem areas Case studies Differing scenarios Identifying links to other EU Directives 2001/20/EC, 91/356, 2001/83/EC Comparison with FDA Guidelines on the preparation of Investigational New Drug Products and links to 21 CFR Part 210 & 211
On-site Courses:	This course can be delivered to a group of up to 12 delegates at your premises. Request a quote for an onsite course.
Further Details:	Request more information on this training course.
Related Courses:	GAMP® 4 (3 Day) Training GAMP® 4 Training Understanding FDA Audits Training Understanding the Regulation 21 CFR Part 11 Training Understanding Validation Training
Course Calendar:	View Course Calendar

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