New for 2008 - Current Requirements for Cleaning Validation and Disinfectant Efficacy Testing

With Hands-On, Practical Workshops

[Download Course Brochure 108Kb]

Seminar 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 seminar 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 seminar 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 seminar will provide details of current best practice, cGMP expectations, industry trends and regulatory issues for both the EU and US markets.

Seminar 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 seminar 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 seminar 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 seminar 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

Seminar Leaders:
Andy N Marshall CChem, CSci, MRSC, BSc
Technical and Quality Director, Honeyman Group Ltd

Trained as an analytical chemist, Andy joined Glaxo’s Barnard Castle factory in 1990 and was involved with stability testing and formulation development before moving to Sanofi . At Sanofi, he was involved with cleaning validation prior to taking the role of Equipment Validation Manager. Andy then moved to primary pharmaceutical manufacture with Chirex as the Validation Co-ordinator, and latterly as the Operational Quality Manager at both the Dudley (Newcastle) and Annan (Scotland) sites, for Rhodia Pharma Solutions (RPS) and Shasun Pharma Solutions (SPS). Andy also spent a period of time in New Jersey, USA developing the quality systems for the newly acquired pilot plant for RPS. Andy brings with him a broad range of validation (in both primary and secondary pharmaceutical manufacture) and quality assurance knowledge, including FDA and MHRA audit readiness activities and involvement to the Honeyman Group.

Plus other invited guest speakers.

The course language will be 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.

Seminar Fees & Reservations
The fee for the seminar is £1,025.00 (€1,545.00) + VAT . This covers all tuition fees, comprehensive course notes, refreshments and lunch. A seminar certificate of attendance is issued to each delegate who attends the full seminar.   If required, delegates should arrange their own dinner, bed and breakfast as this is not included in the seminar fee.

Discounts:
Book early and receive a 10% discount if payment is received by 25th July 2008.   Discounts are also available for multiple bookings and for government and regulatory agency employees - please contact us for details.

Cancellations:
Written cancellations will be accepted up to 31 working days before the date of the seminar, after which a cancellation fee will be payable.   Unfortunately, no refund can be made for cancellations within 10 working days of the seminar start date and the full seminar fee will be due for delegates who fail to attend.    Substitutions may be made at any time up to the start of the seminar, free of charge.

We reserve the right to change the programme, speakers, date or venue without notice, or to cancel an event. If cancellation occurs delegates will be notified as soon as possible and will receive a full refund of fees paid. Honeyman Group Limited will not be responsible for transportation, accommodation or other costs incurred due to cancellation

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