Course Overview

  • “Great job in covering a huge amount of information in one day"Anon / Regulatory Inspector
  • “I had a requirement to gain knowledge and understanding of sterile processes and sterility to supplement my QP training. The course met my requirements 100%. I appreciate the extra information passed on by the tutors with my QP training in mind.” Anthony James / Norgine, UK
  • “Very dynamic and participative.” Michelle Aprelino Alito / Crucell Holland, The Netherlands

This focused, interactive 1 day course is designed to help you to audit sterile products manufacture with confidence and competence. We will explain to you the major processing steps, the critical control points and the major areas of potential risk.  We will teach you what questions to ask and why, and what answers to expect and why.  If you are new to sterile products, this course if for you!

About This Course

The manufacture of sterile products is perhaps the most hazardous of all pharmaceutical production activities – failures can and sometimes do result in patient harm and death. That is why auditing of sterile filling operations is essential and why it is important that the auditor has the right knowledge and experience to conduct the audit with skill and professionalism.

This highly focused, interactive course is designed to help auditors with little or no direct experience of auditing sterile filling operations to know where the risks lie, what questions to ask and how to assess whether or not processes are under control.

Knowing what to look for, knowing how to assess any GMP deficiencies for criticality and keeping current on cGMPs in this field are all covered in this excellent course.

What You Will Learn

  • What makes sterile products special
  • An overview of relevant GMP guidance
  • The quality critical steps in sterile filling and how to ensure these are under control
  • How to plan an audit of sterile filling, inspection and packing
  • How to assess the effectiveness of utility and environmental monitoring programs
  • The key questions to ask
  • What answers to expect!

Course Tutor

The course tutor will be:

Other Dates and Venues for this Course

  • 9 October 2015 | Amsterdam

This Course Offers Enhancement for the Following Career Paths

  • Sterile Products
  • Audits/Self-Inspections