Current Requirements for Cleaning Validation and Disinfectant Efficacy Testing

With Hands-On, Practical Workshops

DATE	LOCATION	COST	RESERVE
28th - 29th June 2011	Honeyman Group Ltd, Barnard Castle, U.K	£1,175.00 (€1,645.00) + VAT

Course Description:

Cleaning Validation
Validation of cleaning procedures is critical for any cleaning programme as defined in the current GMP Guidelines (Annexe 15, point 36):

“Cleaning validation should be performed in order to confirm the effectiveness of a cleaning procedure”.

Disinfectant Efficacy Testing
Disinfection forms a fundamental part of the maintenance schedule for any manufacturing facility. Recently, there has been an increasing amount of interest in disinfection practices, as inadequate disinfection can have a direct impact on product quality and therefore risk to the patient. Therefore, the use of disinfectant falls under the remit of cGMP and should be controlled as such.

This course will cover subjects such as development of regulatory expectations, effective cleaning procedures and disinfectant regimes, development of effective cleaning and disinfectant agents, and the validation and control of these procedures.

For those new to these subjects, this course will provide a detailed and structured introduction to cleaning validation and disinfectant efficacy testing.

For those who have been working in these areas for some time, this up to the minute course will provide details of current best practice, cGMP expectations, industry trends and regulatory issues for both the EU and US markets.

'A very enjoyable and valuable course, would definitely recommend as someone who is very new to the field of validation it was very informative.'
Validation Technician, Protherics UK Ltd, Ceredigion, UK

Course Programme:

Regulatory Requirements of Cleaning Validation and Available Guidance:

Methods of Cleaning
• Manual
• Automated (CIP and SIP)
• COP

Disinfection Efficacy
• Disinfectants and the Selection Approach
• Practical Workshop
• Efficacy Testing

Cleaning Procedures
• Cleaning Validation Master Plans
• Establishing Methods of Cleaning
• Protocol Development
• Development of Cleaning Acceptance Criteria
• Cleaning Reports

Analytical Cleaning Methods
• Analytical Methods and Validation
• Sampling Techniques and Workshop
 
Maintaining the Cleaning Validation State
• Cleaning Stability Studies
• Change Control

Industry Case Studies
• From API to Finished Products
• Regulatory Comments

Who Should Attend?

The course is ideal for anyone wishing to gain or increase their knowledge of cleaning validation and disinfectant efficacy testing within the pharmaceutical industry. The two day course will focus on the technical aspects of the subject areas and will include some practical workshops that will be held in the Honeyman Laboratories. Attendance will provide a comprehensive overview of cleaning validation and disinfectant efficacy testing and how current technologies and guidelines meet these requirements. The course is designed for anyone involved in cleaning validation activities, whether this is during the design stage, execution or throughout overall management, including:

• Quality Assurance
• Quality Control (Chemists and Microbiologists)
• Regulatory Affairs
• Validation
• Production Managers and Operators
• Auditors

Course Leader:

Dave Chadwick
Senior Microbiology Consultant, Honeyman Group Ltd

Roles with some of the World’s leading research based companies including Shell And GlaxoSmithKline, followed by five years with Honeyman have resulted in Dave gaining an impressive knowledge of microbiological analysis, interpretation and troubleshooting. As the Honeyman Group’s Senior Microbiology Consultant, Dave has taken the lead role in a number of pioneering projects which have resulted in the development of new methods and techniques aimed at overcoming problems with existing standards and increasing the accuracy of the microbiological analysis of raw materials, finished products and medical devices.  Since the introduction of ASTM:2500, Dave has been increasingly involved in a number of risk based studies commissioned by clients to identify opportunities to minimise analytical testing and has latterly been instrumental in the establishment and operational management of the Honeyman Group’s new analytical laboratories in Dublin, Ireland.

Plus other invited guest speakers.

Course Language:

The course will be delivered in English.

The Venue:

Honeyman Group Ltd, Barnard Castle, UK
Tel: +44 (0)1833 690101,     Fax: +44 (0)1833 690102,      Web: www.honeyman.co.uk

For courses held in our purpose built facility in our Barnard Castle Head Office, we recommend the Jersey Farm Hotel for those who require accommodation.  We offer delegates a pick up and drop off service to and from the hotel and our office on the course days.
The Jersey Farm (Tel: +44 (0)1833 638223, Fax: +44 (0)1833 631988, www.jerseyfarm.co.uk) is situated in its own grounds within 10 acres of farm land, just a two minute car journey from the centre of Barnard Castle, an historic market town full of character built around the 12th Century castle from which it takes its name.

Course Fees & Reservations:

The fee for the course is £1,175.00 (€1,645.00) + VAT where applicable.  This covers all tuition fees, comprehensive course notes, refreshments and lunch. A course certificate of attendance is issued to each delegate who attends the full course. Delegates should arrange their own dinner, bed and breakfast, as it is not included in the course fee. Remember, when reserving your accommodation to mention that that you will be attending a Honeyman course, this will entitle you to the discounted room rates that we have negotiated for you. For ease and convenience, we recommend that you stay in the hotel which is hosting the course. However, alternative accommodation can be arranged, details of which can be obtained from the local tourist information centre.

Booking Conditions

Book early and receive a 10% discount if payment is received 6 weeks prior to the course start date. Further discounts are also available for multiple bookings and for government and regulatory agency employees - please contact us for details. Cancellations received and confirmed by the Honeyman Group will incur a 20% fee up until 31 working days before the start date of the course, after which a sliding scale of further cancellation fees will be applied. No refund will be made for cancellations within 10 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.  Reservations not confirmed by payment by the course start date will be allocated to any persons on a waiting list. Payment can be made by bank transfer or cheque. Alternatively register via our website and pay by credit/debit card.

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 Group Ltd will not be responsible for transportation, accommodation or other costs incurred due to cancellation. We reserve the right to charge an administration fee to those delegates who fail to attend a course through no fault of Honeyman Group Ltd, but wish to have their place transferred to the next available course.

To reserve your place, please complete a Registration Form and a Payment Details Form and forward to Honeyman Group Ltd by either by post, fax or e-mail. Or register via our website at www.honeyman.co.uk Upon receipt of registration, Honeyman will forward written confirmation and VAT invoice.

Receipt of this form by Honeyman Group Ltd consists a binding registration.

To avoid disappointment an e-mail/telephone/fax reservation is advisable prior to sending your booking form and payment.