New for 2008 - Updated to Include Risk Based Approach to
Steriliser Validation and the Application of ASTM 2500
Only Interested in the Operational and
Regulatory Aspects of Sterile Product Manufacture? - Attend Part 1 (18th & 19th
Nov)
Prefer to Focus on the Technical and Engineering Aspects of Sterile Product
Manufacture? - Attend Part 2 (20th & 21st Nov)
Attend All 4 Days For The Most Comprehensive
Short Course on Sterile Product Manufacture, Delivered by QP's, Microbiologists,
Engineers, Chemists & Regulatory Aspects (18th - 21st Nov)
|
DATE |
LOCATION |
COST |
|
18th - 21st November
2008 |
|
Honeyman
Group Ltd, Barnard Castle, U.K. |
See Detailed
Section Below
|
[Download Course Brochure 366Kb]
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.
Run as individual courses in the past, we are now, for the first time
delivering both courses together as a 4 day comprehensive review of the sterile
product manufacturing process. Dependent upon your requirements, attend solely
Part 1, solely Part 2 or the whole course.
All of the lecturers are actively involved in the industry and will base their
lectures on their current knowledge, feedback from recent inspections and
todays 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.
Course Programme:
PART 1: OPERATIONAL AND REGULATORY ASPECTS OF STERILE PRODUCT
MANUFACTURE: 18th & 19th NOVEMBER 2008
The first of a two part course covers the operational aspects of sterile product
manufacture. The regulatory framework, production, controls and monitoring of
the process.
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 dos and donts? 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 Steriles Manufacturer or a Microbial
Laboratory?
PART 2: TECHNICAL AND ENGINEERING ASPECTS OF STERILE PRODUCT MANUFACTURE:
20th & 21st NOVEMBER 2008
The second part of this course covers technical and engineering aspects 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.
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. Part 1 focuses on
the operational aspects of sterile product manufacture, whereas Part 2 examines
the technical and engineering aspects. Attending Part 1 and Part 2 will provide
the most comprehensive overview of operational requirements and how the current
technology and engineering standards meet these requirements. In the past both
courses have been attended by:
Production Managers & Key Production Staff
QA Personnel including Site QPs
Microbiologists
Engineering, Technical & Validation Personnel
Regulatory Personnel Interested in Product/Site Registration
QA and Audit Personnel Looking to Outsource Sterile Product Manufacture
and US markets.
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.
Seminar 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 LtdMark's
engineering background in the Pharmaceutical and Medical Device Industries
includes Eli Lilly, Rhone Poulenc Rorer and Smith & Nephew Medical, specialising
in Sterilisation Technology, Engineering and Microbiology, and also having
extensive Regulatory Compliance experience. Mark has trained
thousands of people around the world and bases all of the training lectures on
the practical experience of the Honeyman Group in these fields, ensuring that
the training is always up to date and built upon real life experiences.
Gavin Ross BEng: AMIMechE
Operations Director, Honeyman Group Ltd
Prior to joining Honeyman Group,
Gavin worked in the Pharmaceutical and Medical Device Industry for 10 years at
Convatec and Smith & Nephew Medical. He has had a variety of
engineering roles during this time including Plant Process Engineer, Project
Engineer, Site Sterilisation Engineer, Validation Specialist and most recently
as Validation and Change Control Manager. Gavin brings with
him a broad range of validation experience including 21CFR part 11, Conversion
Processes, Water Systems, Air Handling (HVAC), Cleaning and Aseptic Manufacture.
He also has extensive experience of risk assessment techniques including hazard
analysis (HACCP/HAZOP) and Failure Mode Effects and Criticality Analysis (FMECA).
Wilma Meijs, PhD
Consultant, Pharmaceutical Consultancy Services (PCS)
After her study in chemistry (RUU), Wilma did her PhD thesis on the development
of radio pharmaceuticals (VU). She has more than 11 years experience within the
pharmaceutical industry, in positions such as QA and QC Manager for different
pharmaceutical businesses, including MSD, Teva and AMT. For the last 3 years she
has been a Senior Consultant/Interim Manager for PCS.
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 2 days (if attending either Part 1 or Part 2) is £1,050.00
(1,575.00). If you wish to attend all 4 days (the whole course) the fee
is £1,950.00 (2,925.00), both plus VAT where applicable. 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 3rd October 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.
