Date Sur Demande
A-Z of Sterile Products Manufacture
Royaume-Uni, Manchester
Entrée : 3 000,00 £ (HTVA)
Déjeuner:
inclus
Early bird and multiple delegate discounts available. Discounts also offered to NHS staff, regulators and charities.
Course Overview :
The original and still the best! We have been hosting this highly participative and extremely popular 4 day training course nearly 30 years and have trained literally thousands of pharmaceutical industry professionals around the world in that time. Come and learn the key scientific, technical and regulatory challenges associated with the manufacture of sterile products and how to implement an effective and compliant quality system to assure the safety and quality of the products you make. Whether you need to meet EU, FDA or any other regulatory agency’s needs, this course will give you the knowledge, skills and tools to succeed! This course is also RSC Approved.
About This Course:
From air change rates to Z values and everything in between!
When a pharma product is administered parenterally, it bypasses the body’s natural defense mechanisms and any quality defect has the potential to cause serious harm to the end user. It is easy to overlook the key quality attributes of the sterile products or not appreciate which parts of your Quality Management System provide both identification and mitigation of risk.
This RSC approved course concentrates on how product quality is assured via practical and interactive review of the science and compliance behind sterile products manufacturing.
Linking everything you do to providing a safe and efficacious formulation to the end user is critical, so via case studies, models and practical exercises, we help you make the connection.
Key Learning Objectives:
- Equip your staff with the know how and know why of common sterile production methods
- Know how to identify and tackle the key quality risks
- Know how to perform focused GMP audits of sterile facilities
We want you to learn, be engaged and have fun as well as take away practical knowledge that is immediately useful back in the workplace. Carefully designed case studies, teamwork tasks and problem solving exercises (facilitated by highly experienced course tutors) will ensure that you ‘learn by doing’. We will also provide ‘exhibits’ – pumps, valves, filters, BIs, vessels and model clean rooms – for you to handle, discuss and interpret.
We help you to see, evaluate and act on the common production and QC concerns in sterile formulation.
New sessions for 2017:
- Insight into the latest draft of EudraLex Annex 1
- How to plan and execute effective internal audits of sterile facilities
- Optional post-course assessment that verifies proficiency of all course attendees
Registration link :
- NSF Online registration : Link
NSF contact :
- Phone : +44 (0) 1751 432 999
- email : pharmacourses@nsf.org
- visit : www.nsf.org/info/pharma-training
Note :
- All of our courses can be brought on-site, tailored to your key concerns and delivered at a time that suits you.
Course Outline :
Regulatory Standards for Sterile Products
- What they are
- How to interpret
- Regulatory hot topics: Present and future
Creating the ‘Controlled Environment’
The design, validation, operation and maintenance of :
- Clean rooms
- Isolators, RABs, BFS
- Sterile preparation and formulation
- Aseptic and TS production methods
- Environmental monitoring – the what, the why and the how
- Routine disinfection – a quality critical activity!
Critical Utilities
The design, validation, operation and maintenance of :
- Steam
- Water (from bore hole to water for injection)
Sterilization Processes : Everything you need to know
- Moist heat (autoclaves)
- Dry heat (ovens and tunnels)
- Filtration
- Irradiation
- VHP surface sterilization
Process Simulations (Media Fills): The what, the why, the how and ‘what if’
- Regulatory requirements
- How to design media fills ‘fit for purpose’
- Best industry practice
- What to do when they ‘fail’!
Container Integrity and Particulate Inspection
- How to validate and test
- How to manage failures. From root cause investigation to CAPA implementation
People Issues
- How to select, educate and manage clean room staff
- Gowning and good aseptic practices
- How to motivate and lead by example
Problem Solving and Troubleshooting (dealing with the unplanned)
What to do when things go wrong
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John McCool
Consultant in Biotechnology
PGCE, PGDip, MRSC
-
Richard Funnell
Consultant in Biotechnology
M.A., MRSC
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John Johnson
Johnson
FRSC, CChem, MIQA
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Darren Jones
Consultant in Biotechnology
Pharmaceutical auditing, consulting and regulatory inspection
Résumé
John has a particular expertise in sterile manufacturing and the application of GLP, GMP and GCP to the manufacture and control of Clinical Trial materials.
Richard Funnell has 30 years’ experience in the pharmaceutical industry in both regulatory and industrial roles. He worked within the MHRA GMP inspectorate from 2003 until 2014, including seven years as a senior inspector when he was the lead for investigational medicinal products (IMP) Good Manufacturing Practices (GMPs).
While at the MHRA, he inspected over 300 different sites within the UK and overseas. He also presented at numerous conferences and symposia on a wide variety of GMP-related topics.
Before joining the MHRA, Mr. Funnell spent 17 years in industry in a number of roles in the production and quality assurance of tablets, oral liquids and sterile products.
He became QP eligible in 2002 after attending the NSF series of courses.
Executive Director at NSF, John has vast experience in preparing sites for regulatory GMP inspections, preparing or remodelling biopharma and steriles facilities, installing quality systems and helping companies embed the right culture for long term sustainable growth. A passionate educator, John has a track record of improving service, improving margin and ensuring perpetual GMP inspection readiness.
Darren Jones has 25 years of experience in pharmaceutical auditing, consulting and regulatory inspection support and preparation. Prior to joining NSF, Mr. Jones worked at MHRA where he spent four years as a GMP inspector. He inspected many sites of varied dosage forms worldwide and developed considerable experience of complex aseptic manufacture and terminal sterilization for both commercial and clinical trial applications.
Earlier in his career, Mr. Jones spent 18 years in a number of roles at AstraZeneca, including production outsourcing, selecting and managing contract manufacturing sites primarily engaged in sterile manufacture.
Mr. Jones has provided QA support to an API facility which included laboratory-scale production for parenteral products, traditional manual plant and modern computer-controlled facilities. He has also provided QA support to tablet processing and packaging activities.
Mr. Jones’ areas of expertise include:
- GMP auditing of facilities and processes
- Sterile manufacture
- Clinical trial manufacture
- Supply chain excellence
- Microbiological QC