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

"FULLY SUBSCRIBED" 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!

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 Pharmaceutical Quality 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

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

Course Tutors

Course tutors will be:

  • 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.
  • Eric Dewhurst; Eric has held senior positions in Microbiology, Validation, Quality Assurance and Regulatory Compliance in a number of major companies, also acting as EU qualified person. He has extensive experience with the UK MHRA inspecting plants manufacturing sterile products. 

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)  £3,000.00

DISCOUNTS AVAILABLE
Early bird and multiple delegate booking discounts available. Discounts also offered to NHS staff, regulators,
charities and some self-funding individuals – 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.

Register