Newcastle, United Kingdom
This Active Substances (AS) and Excipients training course gives a unique insight into the regulatory expectations associated with producing both chemically synthesized and biological/biotech ASs. The course also provides insight and expertise on managing global AS supply chains, vendor quality assurance and “how to audit” AS facilities. We summarise the key steps in identifying and removing impurities, including some updated information on the impact of potential nitrosamine formation. During the course we will also visit Active Substance manufacturing facilities to see how the theoretical requirements are implemented in real life.
This course fulfils the requirements of the Qualified Person Study Guide and we don’t just train to pass a viva, we take the time to prepare you for your career ahead.
This course is approved by the Royal Society of Chemistry as suitable for its members’ continuing professional development.
As AS supply chains become ever more diverse and cost pressures more acute, the pharma manager needs a keen appreciation of risk factors, design, control and monitoring of AS sources. This course allows delegates to differentiate between natural variation and risk across a range of AS processes, indicating the most appropriate and proportionate actions to take to mitigate any areas of concern.
You will be provided with an overview of the EU and US regulatory framework surrounding active substance and excipient manufacturing process and be given practical guidance on the key responsibilities of the Qualified Person when approving a GMP declaration.
You will also learn:
The course will also allow you to make informed decisions when faced with a range of GMP non-conformances during AS production.
Our detailed educational material grows into a lifelong reference library.
For chemically synthesized and biological/biotech produced APIs, the course includes:
Course tutors will be selected from the following:
David Waddington – David’s career in the pharmaceutical industry spans more than 30 years in various quality roles for three major international pharmaceutical organizations. Dave is eligible to act as a Qualified Person under the permanent provisions. He has broad experience in QA and manufacturing management gained through working with a wide range of dosage forms for global supply, including solids, liquids, sterile products, food supplements and natural products.
Neil Wayman – Neil is an experienced quality professional with over 30 years of experience in pharmaceutical quality. Neil has worked as a QP and RP and has experience of Stability testing and the manufacture of APIs , solid oral dose and sterile injectables (terminally sterilised and aseptic). Neil has extensive experience managing all aspects of manufacturing site and global quality management systems, including inspection/audit management, issue management and site remediation, as well as global supply chain assurance activities associated with external manufacture and distribution.
Robert Smith – Robert has more than 30 years’ experience in the pharmaceutical industry, in various production and quality roles for a number of major international organizations. He is eligible to act as a Qualified Person under the permanent provisions for both commercial and investigational medicinal products. He is a QP assessor and Vice Chair of the Royal Pharmaceutical Society Panel of Assessors. Robert has broad experience in QA and manufacturing management gained through working with a wide range of dosage forms for both commercial and clinical supply, including solids, liquids, sterile products, vaccines, biological, biotechnology, viral vectors, gene therapy and cellular therapy products.
Eurwyn Roberts – Eurwyn has over 30 years’ operational QA and management experience in vaccine and therapeutic biological product manufacture across process and analytical development, technology transfer and as a QP for clinical and commercial manufacture of API and sterile small volume liquid and lyophilised drug products.
Multi-delegate discounts available. Discounts also offered to NHS staff and charities.
Learn the essential elements of an effective, compliant, modern pharmaceutical quality system.
Gain knowledge and understanding of international pharmaceutical legislation so you can carry out your duties with skill and authority.
Get detailed insight into the challenges in producing and testing biotech and biological pharma products.