The course is suitable for all personnel involved in the management and operation of cleanrooms including Production Managers and Supervisors, Quality Assurance, Microbiologists, Sterility Assurance Specialists and Sterility Assurance Engineers.

• Delegates will be able to identify the sources of contamination, routes of transfer to the product and contamination control measures and apply this in their facility.
• The course will provide a scientific assessment of the fundamental mechanism of contamination transfer, via surface contact or from airborne deposition, and how this mechanism is used to provide the most accurate methods of assessing risk of microbial contamination of product.
• Delegates will recognise how the identified risks, or their methods of control can be monitored and limits set to ensure that contamination is adequately controlled are outlined.
• Delegates will recognise the advantages of using a quantitative system to assess and prioritise risk based on actual process data.
• Methods of periodic verification that the contamination system is under control will be presented.
• Delegates will participate in risk assessment workshops lead by industry experts to enhance learning and facilitate debate.
• Methodology will be presented to determine the microbial risk to patient from aseptically prepared products.

Full course notes and a certificate of attendance will be issued to each delegate who attends the full course. Certification is for knowledge gained, not just attendance. Assessment for Aseptic Filling Process.

Day One

• Risk Management of Contamination (RMC) during Cleanroom Manufacture, choice of Microbial Risk Assessment Method and Fundamental Mechanism of Contamination Transfer
• Identification of Sources of Contamination, Transfer Routes, Key Control Measures and the use of Risk Diagrams
• Risk Assessments for General Cleanroom Areas
• Risk Assessment for Aseptic Filling Processes
• Risk System, Assessment of Manufacturing Stage Risks and Areas for Aseptic Improvement

Day Two

• Risk Assessments for Critical Area Contamination, Airborne Deposition
• Risk Assessments for Critical Area Contamination, Surface Contact
• Establishment of an Effective Monitoring Programme, Regular Verification of the Risk System, Documentation and Staff Training
• Assessing Microbial Risk to Patients from Aseptically Manufactured Products

Please note: Our online booking system works in £GBP.  Honeyman Training & Consultancy Limited reserves the right to amend any prices at any time.

All advertised prices are exclusive of any applicable VAT or local taxes.

Click here to read our Pharmaceutical Training Course Terms & Conditions.