A-Z of Sterile Products Manufacture

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

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