Updated to Include Risk Based Approach to Steriliser Validation and the Application of ASTM 2500

DATE	LOCATION	COST	RESERVE
2nd - 5th November 2010	Rochestown Park Hotel, Cork, Ireland	£2,150.00 (€3,010.00) + VAT
12th - 15th April 2011	Barnard Castle, U.K.	£2,150.00 (€3,010.00) + VAT

Course Description:

The manufacture of sterile products is subject to special 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. Whether involved in production, QA, QC, Engineering or Regulatory Affairs, this course will be relevant to you.

All of the lecturers are actively involved in the industry and will 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 case studies in the course. All of the lecturers will be available throughout the course to answer specific questions on any related topic.

'The course covered all the key areas I would expect to be covered.  The 4 day course was pitched just right.'
Quality Systems Officer, TEVA UK Ltd, Eastbourne, UK

Course Programme:

OPERATIONAL AND REGULATORY ASPECTS OF STERILE PRODUCT MANUFACTURE:
The operational aspects of sterile product manufacture, the regulatory framework, production, controls and process monitoring.
• International Guidelines Related to Steriles Manufacturing:
• Current Guidelines.
• Expectations for Future Guidelines.
• FDA and EU.
• An Introduction To Microbiology:
• Micro Organisms, What Are They?
• Which Factors do Micro Organisms Need to Survive/Stay Alive?
• How Can we Kill/Destroy Micro Organisms?
• Media Simulations (e.g. the simulation of filling processes and other aseptic handlings)
• Hygiene Zone Concept:
• The Design Criteria for Clean Rooms.
• The Different Classes and Their Specific Criteria.
• Which Activities Should be Performed in Which Class?
• The Validation of a Clean Room Complex.
• What is a Pressure Cascade and What are the Expectations?
• What is an Isolator and what Different Types of Isolators are Available?
• Environmental Monitoring:
• Regulatory Expectations.
• What are the Different Techniques? What Technique Should be Used?
• Setting up an Efficient Trend Analysis.
• How to React When Excursions Occur?
• How to Set Action and Alert Limits?
• Cleaning and Disinfection:
• What is the Difference?
• Which Rules are Essential for Efficient Cleaning and Disinfection?
• How to Validate Disinfection Methods?
• The different aspects that are of importance for performing microbial testing (e.g. The Bioburden Test, the LAL Test and the Sterility Test)
• Essential Aspects for the Qualification of Clean Room Personnel
• Who Should be Qualified?
• How to Qualify Personnel for Different Clean Room Activities?
• Rules for Working in Clean Rooms; The do’s and don’ts? What are the Rules Concerning Clean Room Clothing?
• Which Aspects are of Importance for Releasing Sterile Products?
• Review of Batch Documentation, Including Remarks/Deviations
• How to Set Up an Audit for a Sterile Manufacturer or a Microbial Laboratory?

TECHNICAL AND ENGINEERING ASPECTS OF STERILE PRODUCT MANUFACTURE
Technical and engineering aspects necessary for delivering, supporting, maintaining and monitoring a successful sterile product manufacturing facility and process.
• Regulatory Framework and Guidance for System Design and Technology.
• Sterile Facility Overview.
• Regulatory and Guidance Framework from Legal Requirements to Current Trends and How to Monitor Them.
• Introduction to Microbiology for Non Microbiologists.
• Focusing on the Information and Understanding that Non Microbiologists Need to Properly Engage in Environmental Monitoring and Controls. Process Simulation Failures, Bioburden Monitoring etc. Proper CAPA Requires a Team of Knowledgeable People.
• Process Simulation: Technical Considerations.
• Qualifying and Planning in Engineering Activities.
• Engineering Interventions.
• Process Understanding.
• Introduction to Quality Critical Utilities for Sterile Product Manufacture.
• Quality & Control Requirements and Why They Have to be Treated Separately.
• Compressed Air and Process Gases (Nitrogen, Carbon Dioxide etc.).
• Water Types and Their Application in Manufacture.
• Clean / Pure Steam Quality and Use.
• The Technology of the Manufacturing Environment.
• Cleanroom Specification and Design. Control Techniques and Monitoring.
• Validation and Routine Testing Requirements.
• HVAC Design, Control and Monitoring.
• Sterilisation Methods and Controls.
• Process Sanitisation and Sterilisation; When to Apply.
• SIP of Vessels and Pipework Systems.
• Equipment SIP.
• Alternative Sterilisation Methods.
• Risk Based Approach to the Manufacturing Process.
• ICHQ9, ASTM2500 - The Regulatory Guidance.
• Application of Risk Assessment Techniques. HACCP, FMEA.
• Validation Master Planning.
• Cleaning Validation.
• Disinfection Efficacy Testing.
• CAPA and Change Control.
• A Guide to Inspections Workshops.

During workshops, delegates will have the opportunity to apply the knowledge gained from the theoretical lectures.

Who Should Attend?

This course is ideal for anyone wishing to gain, or increase their knowledge of the critical factors concerning sterile product manufacture.  In the past this course has been attended by:

• Production Managers & Key Production Staff
• QA Personnel including Site QP’s
• Microbiologists
• Engineering, Technical & Validation Personnel 
• Regulatory Personnel Interested in Product/Site Registration
• QA and Audit Personnel Looking to Outsource Sterile Product Manufacture

For those new to the industry or to sterile product manufacture, this will provide a detailed and structured introduction to the key aspects and requirements. For those who have been working with sterile products for sometime, this up to the minute course will provide details of current GMP expectations, best practice, industry trends and regulatory issues for both EU and US markets.

Other Courses You May Be Interested In...:

• Sterilisation: Principles in Practice

• Advanced Sterilisation and the Application of Biological Indicators

• Environmental Monitoring

• Current Requirements for Cleaning Validation and Disinfectant Efficacy Testing

Course Leaders:

Ian K. Sykes PhD
Director, Pharmaceutical Consultancy Services (PCS), The Netherlands
Ian qualified in Microbiology, Immunology and Virology. After working in the pharmaceutical industry Ian joined the U.K. Medicines Inspectorate, with responsibility for biological and biotechnology products. He established PCS in 1990 and with a global customer base, PCS offers services in consultancy, auditing and training for the pharmaceutical, chemical and related healthcare industries. Ian is a registered Qualified Person.

Mark Thompson C.Eng. MIEE BSc
Managing Director, Honeyman Group Ltd
Mark's prolific background in the pharmaceutical and medical device industry spans more than twenty years.   Various engineering management roles with the world’s largest household names including Eli Lilly, Rhone Poulenc Rorer and Smith & Nephew Medical have seen Mark leading engineering teams through an array of engineering projects driven by capacity relief, new product introduction, profit improvement and regulatory compliance.  A Chartered Engineer and Member of the Institute of Electrical Engineers, Mark primarily specialises in control and instrumentation projects within sterile manufacturing operations.     

Gavin Ross BEng: AMIMechE
Operations Director, Honeyman Group Ltd
Heading up the Honeyman Group’s Technical Operations Division, Gavin is now heavily involved in conducting site feasibility studies and risk assessments for a number of major clients across the world. Specialising in sterile product manufacture and aseptic processes, Gavin spent the early years of his career with leading household names such as Smith and Nephew.  Gaining a wealth of experience in the fields of engineering, QA validation and latterly change control, Gavin was involved in several major projects relating to technical change and new technology introduction, cleanroom design and specification and site wide change control management.

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 Venues:

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.

Rochestown Park Hotel, Cork, Ireland
Tel: +353 (0) 21 489 0800,     Fax: +353 (0) 21 489 2178,     Web: www.rochestownpark.com

The Rochestown Park is a luxurious manor style hotel with mature gardens, incorporating 163 rooms, an award winning health and leisure centre and Ireland's first Thalasso Therapy Clinic. The hotel is only five minutes from Cork Airport.

Course Fees & Reservations:

The fee this course is £2,150.00 (€3,010.00) plus 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.