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19 June 2018 09:00 - 20 June 2018 16:00, Reading, United Kingdom
Introduction
Who will the course benefit?
This Sterile Products course is aimed principally at personnel involved in the management and supervision of sterile product manufacturing facilities. The course is also of great benefit for personnel involved in support activities, such as environmental monitoring personnel, Quality Control and Quality Assurance Officers/ Managers and Engineers.
Sterile Products Course overview:
Delegates will learn about the GMP requirements for sterile products and areas likely to be looked at during Regulatory Inspection. The course provides delegates with an increased knowledge of the GMP requirements for individuals in positions where this is essential for their effective performance and decision making.
Course contents:
Day 1 Sterility and sterile products
The need for sterile products
Basic Microbiology
Types of contamination
Contamination sources
Types of manufacture (Aseptic verses Terminal Sterilisation)
Sterile product manufacturing, including vials and ampoules, pre-filed syringes and Blow-Fill-Seal
GMP requirements for sterile products, including EU GMP Annex 1 and FDA guidelines/ rules
Sterilisation and disinfection
Day 2 Cleanroom design, qualification and operation
Cleanroom design, qualification and operation
HVAC systems – an overview
Environmental Monitoring
Media Fills
Test for Sterility
People factors
Parametric release of sterile products
Useful links
Speakers
Mr Andy MartinUnited Kingdom
Venue
Holiday Inn
Holiday Inn, Reading South, Reading, RG2 0SL, United Kingdom
Dominic Parry
Inspired Pharma Training
1210 Parkview, Arlington Business Park, Theale, Berkshire, RG7 4TY, United Kingdom
+44 1635 866699
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