ICourse Overview
“Really educational course. Good dynamic between lecture and teamwork. Not just a read through of guidelines but a proper insight to what is GMP. The course has changed my mindset on manufacturing of sterile products.” Maria Thestrup Kristensen / Novo Nordisk, Denmark
“Good balance between teamworks and lectures. I enjoyed every minute of every session and received a bright overview on the manufacturing processes.” Joanna Klimczuk / F Hoffmann-La Roche, Switzerland
“The trainers are real professionals. You get a really good and valuable overview of sterile manufacturing. A course which is definitely worth it!” Saskia Spahn / Hoffman-La Roche, Switzerland
The original and still the best! We have been hosting this highly participative and extremely popular four-and-a-half-day sterile products training course for over 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 that 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!
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 defence 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 pharmaceutical quality system (PQS) provide both identification and mitigation of risk.
This 91AV (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
On completion of this course delegates will know and understand:
The know how and know why of common sterile production methods
How to identify and tackle the key quality risks
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 cleanrooms – 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.
Updated session for 2019:
Insight into the latest draft of EudraLex Volume 4 Annex 1 and how it affects your facility design, your aseptic process and the training of your staff
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:
Cleanrooms
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 sanitization
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 cleanroom staff
Gowning and good aseptic practices
How to motivate and lead by example, understanding, promoting and enforcing good aseptic behaviors
Problem Solving and Troubleshooting (dealing with the unplanned)
What to do when things go wrong
“Really educational course. Good dynamic between lecture and teamwork. Not just a read through of guidelines but a proper insight to what is GMP. The course has changed my mindset on manufacturing of sterile products.” Maria Thestrup Kristensen / Novo Nordisk, Denmark
“Good balance between teamworks and lectures. I enjoyed every minute of every session and received a bright overview on the manufacturing processes.” Joanna Klimczuk / F Hoffmann-La Roche, Switzerland
“The trainers are real professionals. You get a really good and valuable overview of sterile manufacturing. A course which is definitely worth it!” Saskia Spahn / Hoffman-La Roche, Switzerland
The original and still the best! We have been hosting this highly participative and extremely popular four-and-a-half-day sterile products training course for over 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 that 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!
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 defence 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 pharmaceutical quality system (PQS) provide both identification and mitigation of risk.
This 91AV (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
On completion of this course delegates will know and understand:
The know how and know why of common sterile production methods
How to identify and tackle the key quality risks
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 cleanrooms – 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.
Updated session for 2019:
Insight into the latest draft of EudraLex Volume 4 Annex 1 and how it affects your facility design, your aseptic process and the training of your staff
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:
Cleanrooms
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 sanitization
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 cleanroom staff
Gowning and good aseptic practices
How to motivate and lead by example, understanding, promoting and enforcing good aseptic behaviors
Problem Solving and Troubleshooting (dealing with the unplanned)
What to do when things go wrong
