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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 Martin United Kingdom

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Venue

Holiday Inn

Holiday Inn, Reading South, Reading, RG2 0SL, United Kingdom

Useful links

Organised by

Contact information

Dominic Parry
Inspired Pharma Training
1210 Parkview,
Arlington Business Park,
Theale,
Berkshire,
RG7 4TY,
United Kingdom
+44 1635 866699
Contact us by email

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