Course 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 / Statens Serum Institut, 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 / 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 4 day 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 Royal Society of Chemistry (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 sessions for 2018:

  • Insight into the latest draft of EudraLex Annex 1 and how it affects your facility design, your aseptic process and the training of your staff
  • Optional post-course assessment that verifies proficiency of all course attendees

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

Course Tutors

Course tutors will be selected from the following:

  • Darren Jones; With extensive operational QA experience and most recently as an MHRA inspector specializing in sterile products, Darren is an internationally recognized expert in his field. His unique insight is indelibly linked to how to audit in a way that provides accurate identification of GMP deficiencies and proportionate assessment of product, patient and GMP risk.
  • John Johnson; Vice President at NSF, John has wide experience in preparing sites for regulatory GMP inspections, preparing or remodeling 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 fine track record of improving service and margin; to ensure perpetual GMP inspection readiness.
  • Richard Funnell; Richard worked in the manufacture of sterile products in production and QA/QP roles for a number of years before joining the MHRA in 2003. There he inspected a huge variety of sterile manufacturing operations worldwide before joining NSF in October 2014.
  • Eric Dewhurst; Eric has held senior positions in microbiology, validation, quality assurance and regulatory compliance in many major companies, also acting as EU qualified person. He has extensive experience with the MHRA inspecting plants manufacturing sterile products.
  • Roger Guest; Roger is a registered pharmacist who has held senior leadership roles within R&D, manufacturing and QA with several pharmaceutical and biotechnology companies. His specialist expertise is in development of IMPs, steriles and biologicals from initial formulation to full commercial manufacture and the development of effective PQS at site and corporate level.

Other Dates and Venues for this Course

For other dates and venues for this course, visit our course calendar

Course Fees

Course cost (excluding VAT)  £3,090.00

DISCOUNTS AVAILABLE

Early bird and multiple delegate booking discounts available. Discounts also offered to NHS staff, regulators and charities  – contact us for details

Have a question or want to book a place? Contact  pharmacourses@nsf.org - you can also register online by clicking below.

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