Critical Factors for Sterile Product Manufacture Training Course
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 will involve open discussion sessions on current best practices & regulatory trends in sterile product manufacture coupled with case studies to illustrate key points.
| Location | Date | Fee | Book Course |
|---|---|---|---|
| Barnard Castle, UK | 4th - 7th December 2012 (4 Day Course) | £1695/€2095 | Add to cart |
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
Why choose Honeyman?
Why Choose Honeyman?
Over the last 20 years Honeyman Group have trained thousands of people within the pharmaceutical industry. The courses continue to remain popular because they provide delegates with a sound understanding of scientific principles in each technical area, complemented by interactive workshops, discussions, practical demonstrations and case studies to put these principles into practice. All of our courses are delivered by experts who actively work within the pharmaceutical, biopharmaceutical and medical device industries, therefore we will continue to share pragmatic current best practice advice to enable you to meet current GMP and regulatory expectations.
2012 Training Program
In order to provide a more competitive training package in 2012 many of our courses will be held at our Barnard Castle Training facility, which is equipped with autoclaves, BIER vessel, steam system, microbiology and chemistry laboratories to accommodate practical demonstrations and workshops. We have expanded our training team and significantly revised and updated many of our existing courses in conjunction with introducing new 1 day courses on current industry hot topics.
Our 2012 Courses Include
Honeyman Principles in Practice Courses
Three days of intensive training, providing the most detailed and technical examination of a subject. Our most popular and longest running series of courses, suitable for those considering Accredited Specialist status.
Honeyman Professional Level Courses
Designed for system and process owners and managers, classroom based courses combining, practical demonstrations, workshops and discussion forums to give a detailed overview of a particular subject.
Honeyman Applied Courses
This course is aimed at Validation, Engineers & Technical personnel with the sole objective of developing PRACTICAL skills and knowledge
Honeyman Accredited Training Courses
Become an Accredited Specialist and gain an internationally recognised University Certificate in Professional Development.
Honeyman Short Courses
Highly interactive intensive 1 day courses on current industry hot topics.
On-Site Courses
Ideal if you have more than 8 delegates to train, what’s more we’ll tailor the course content to include photographs, video and sample documentation that is specific to your products, your processes, your people and your plant.
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.
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