Date to be announced
Contact us for more infoTRAINING TIMES
of CCS requirements as detailed in the EU Annex 1 Manufacture of Sterile Medicinal Products.
on the successful implementation of the CCS and the impact of failed implementations.
and how they impact on your Quality System. Check the latest regulations and guidance.
within the company organisation and their inputs to a successful implementation of the Contamination Control Strategy.
Three days of expert-led Zoom sessions packed with discussions, Q&As, and real-world scenarios.
All slides, tools, and supporting materials available in our CLIENT ZONE before, during, and after the course.
Receive a digital certificate (also Linkedin-ready) that verifies your skills in strategic trial planning.
Overview of the latest regulations and guidance of contamination control strategy and sterile medicinal products
Design of the plant and processes including the associated documentation. Premises, equipment, utilities.
Raw material controls. Product containers and closures. Vendor approval and outsourced activities.
Process risk management, process validation, validation of sterilisation processes, preventative maintenance.
Cleaning and disinfection, monitoring systems, prevention mechanisms, continuous improvement.
Changes in the supply chain sourcing model for a key component in vial products leads to increased risk.
Designed for professionals who want to enhance their expertise and advance their careers
Rob Walker GMP Consultancy Limited, Director
Rob Walker is a Chartered Chemist and a Fellow of the Royal Society of Chemistry with degrees in Applied Chemistry and Instrumental Analytical Chemistry. He has over 30-year experience in the Pharmaceutical industry including 25 years as a Qualified Person. After 16 years in senior management at CP Pharmaceuticals, the last 7 as Quality Director, he is now a director of his own GMP consultancy company operating across the Global Market. Rob has extensive GMP Manufacturing and Quality experience covering a wide range of dosage forms, in particular aseptic sterile products, and has successfully managed GMP inspections by MHRA and FDA for primary and secondary manufacturing in the UK and overseas. He has performed GMP audits and training encompassing all elements of the global pharmaceutical supply chain. A member of a number of pharmaceutical industry professional organizations, Rob has delivered numerous presentations to Industry/Regulatory forums in both the EU and the USA on current GMP issues. He has edited technical reports for professional bodies on steam sterilization, and contributed to pharmaceutical industry monographs on media fills and integrity testing of sterile products. He has also represented the UK Pharmaceutical Industry in regulatory meetings in the EU and USA.
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