Critical Factors for Sterile Product Manufacture Training Course
This course has been completely revised for 2012 and includes many new topics including the use of Disposable Technology, RABS and Isolator Technology, ETO, Gamma, E-beam, CAPA/OOS, Sterile Product Inspection Techniques and Real Time Release Testing (RTRT).
The manufacture of sterile products is subject to additional GMP controls and relies heavily on the competency and knowledge of everyone involved in the process. This course covers all key aspects of sterile product manufacture, for both aseptically prepared and terminally sterilised products.
This course covers all key aspects of sterile product manufacture, for both aseptically prepared and terminally sterilised products. Open discussion sessions on current best practices and regulatory trends in sterile product manufacture will be coupled with case studies to illustrate key points. All of the course lecturers are actively involved in the industry and base their lectures on their current knowledge, feedback from recent inspections and today’s technology, allowing for the inclusion of practical examples and real life experiences in the course.
| Location | Date | Fee | Book Course |
|---|---|---|---|
| Barnard Castle, UK | 4th - 7th December 2012 (4 Day Course) | £1695/€2095 | Add to cart |
| Barnard Castle, UK | 3rd - 6th December 2013 (4 Day Course) | £1695/€2095 | Add to cart |
Course Content
Day 1
- Risks in Sterile Manufacturing
- Bioburden control in Sterile Product Manufacture
- Review of US FDA Guidance for Aseptic Manufacturing
- Disposable Technology in Sterile Manufacturing
- Sterilisation Technology Overview ETO, GAMMA, E-BEAM
Day 2
- Introduction to Aseptic Manufacturing
- Introduction to Clean Rooms
- General Principles of Clean Room Design
- Risk Management of Contamination in Clean Rooms
- Clean Room Garments for Effective Contamination Control
- Aseptic Behaviors and Techniques
- Aseptic Validation
- RABS and Isolator Technology
Day 3
- Quality Critical Utilities
- Compressed Gases
- Pharmaceutical Water
- Steam
- Filtration
- Auditing Pharmaceutical QC Laboratories
Day 4
- Role of the QP in Sterile Manufacturing
- Hosting Regulatory Inspections
- CAPA/OOS and Root Cause Analysis
- Sterile Product Inspection Techniques
- Real Time Release Testing (formerly Parametric Release)
Who Should Attend
Who Should Attend?
Whether involved in Production, QA, QC, Engineering or Regulatory Affairs, this course will be relevant to you.
Course Objectives
Key learning objectives are:-
- To review the key activities and processes which are critical to the success of sterile manufacturing operations
- To refresh delegates on the special nature of sterile products and understand the challenges involved in aseptic processing and the consequences of failure.
- To develop risk assessment methods and quantify risk
- To apply risk management techniques to control contamination in clean rooms
- Understand how the key aspects of the facility design, personnel, material flows, aseptic behaviors determine the success of aseptic processing.
- How to implement and perform a successful aseptic validation program including practical trail design
- To understand the current sterilisation & sanitisation processes and controls
- To understand the importance of critical utilities in sterile product manufacture including steam, high purity water, compressed gases
- To understand the role of QC laboratories in sterile processes
- To understand the role of the QP in sterile manufacture
- To review the current regulatory requirements and trends in sterile manufacture
- To understand common GMP deficiencies and what inspectors are looking for
Dates & Costs
Dates and CostsPlease see the table above for the dates of next courses and the costs.
Please note: Our online booking system works in £GBP. The € Euro price is a guide price only. The final € Euro amount payable online will be the current exchange rate of the £GBP amount.
If you wish to raise a purchase order or pay via any other means than Credit Card for a booking then these € Euro guide prices will prevail as being the booking cost despite any fluctuation in exchange rates.
Honeyman reserves the right to amend any prices at any time. All advertised prices are exclusive of any applicable VAT or local taxes.
Terms and Conditions
Terms and Conditions
Cancellations received and confirmed by Honeyman will incur a 50% fee up until 31 working days before the start date of the course. No refund will be made for cancellations within 30 working days of the course start date and the full course fee will be due for delegates who fail to attend, (even if the course fee has yet to be received).
Substitutions may be made at any time up to the start of the course, free of charge.
Delegates completing the optional Teesside University Accreditation will incur a 50% cancellation (received in writing and confirmed by Honeyman) fee up until 31 working days before the start date of the course, after which the full course fee will be due.
Cheques and Bank Transfers are to be cashed prior to booking confirmation.
We reserve the right to charge an administration fee to delegates who wish to have their place transferred to another course.
Reservations not confirmed by payment by the course start date will be allocated to any persons on a waiting list.
We reserve the right to change the programme, speakers, date or venue without notice, or to cancel an event.
In the unlikely event of cancellation occurring, delegates will be notified as soon as possible and will receive a full refund of fees paid.
Honeyman is not responsible for transportation, accommodation or other costs incurred.
A full list of all Honeyman Groups terms and conditions of sale is available on request