Good Engineering Practice Training Course
This course has been completely revised for 2012 to reflect the enhanced role of the engineer as described in ICHQ9, Q10 and ASTM E2500
Over the last 10 years there has been a significant change in the way pharmaceutical products are developed and manufactured, therefore we now have a regulatory framework which is focussed on risk based pharmaceutical manufacture. Good Engineering Practice has been highlighted as being an integral part of the quality system in standards like ASTM E2500 along with risk management, design review, change management and continuous improvement.The approach to verification of equipment and facilities is changing with many companies taking the opportunity to redefine GEP in their QMS and their approach to validation, to focus on critical activities and avoid unnecessary repetition of testing during lifecycle activities.
Engineers from all disciplines play a key role in the development and manufacture of pharmaceutical products, with involvement in the specification, design, verification and subsequent maintenance of the facilities, utilities and equipment necessary for the various stages of production. There is now the opportunity for engineers to become Subject Matter Experts and take a lead role in risk based decision making throughout lifecycle activities and take a more prominent role during all stages of production and inspections.
With this progression in GEP philosophy and "system experts" playing a much more significant role in pharmaceutical processes and projects, never has the need been greater for knowledgeable engineers to be an integrated part of all pharmaceutical manufacturing and project processes.Based on current "real world" experiences, this course will highlight how current GMP’s are applied to pharmaceutical engineering and technical services to ensure facilities, equipment and processes are maintained to the correct standard as efficiently as possible..
|Barnard Castle, UK||19th - 20th June 2013 (2 Day Course)||£795/€995||Add to cart|
|Cork, Ireland||29th & 30th October 2013 (2 Day Course)||£795/€995||Add to cart|
- History of the Pharmaceutical Industry in Europe and North America
- Regulatory Framework and Enforcement
- The Role of the Engineer (GEP vs GMP)
- Emerging Approach to GEP
- Contamination Control (API, Excipients, Components, Counterfeiting)
- What Engineers can achieve: The Manufacturing Environment
- What Engineers can achieve: Critical Utilities
- What Engineers can achieve: Water & Steam
- What Engineers Can Achieve: - Compressed Gases
- What Engineers Can Achieve: - Bioburden Control and Sterilisation
- Control of the Operating Condition
- The Quality Management System
- Process Engineering
- Change Control
- Engineers & Inspections
Who Should Attend
Who Should Attend?
This course is suitable for both introductory training and as a refresher course for engineers already working in the pharmaceutical and related healthcare environments.
Key learning objectives of the course are:-
- To provide a broad overview of the history of the Pharmaceutical industry in Western markets and then to describe the framework that evolved to regulate the industry
- To describe and explain the changing role of the Engineering disciplines within the Pharmaceutical industry with particular emphasis on the enhanced role of the Engineer as described in documents such as the ICH guidelines 9 and 10 and ASTM E2500.
- Explore the role of Good Engineering Practice (GEP) in relation to Good Manufacturing Practice (GMP) and investigate the strengths, weaknesses and applications of principles such as risk management. The course material will be enhanced with practical examples of the applications of these principles.
- Specific presentations will be given in the traditional areas of Engineering expertise including design and implementation of critical utilities (water, clean steam, high quality air handling systems and compressed gases). Course participants will be given an understanding of the basic microbiology important to the Pharmaceutical industry and this will be applied in the context of the importance of bioburden control for sterilisation methods such as filtration and application of heat.
- The course will complete by illustrating the role of the Engineer in pharmaceutical quality management systems from project engineering through operational management of quality and involvement in plant inspections.
Dates & CostsDates and Costs
Please 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