What delegates have said about recent courses:
“This was probably the best classroom based course I have ever been on”
"Lively, interesting presentations with useful anecdotes and examples; excellent take away materials"
Dates - 6th November 2012
Providing an overview of the quality and regulatory issues surrounding the development and production of biopharmaceuticals for global use, this one day workshop is suitable for QA professionals and newly-appointed managers who are moving into biopharmaceuticals, and regulatory professionals who need to understand the quality issues associated with the manufacture of biopharmaceuticals. It covers the regulatory approaches used in Europe and the US, differences between small molecule drugs and biopharmaceuticals from a quality point of view, the different types of biopharmaceutical and associated quality issues, the importance of the manufacturing process - production systems, issues associated with scaling up, the importance of facilities design, the role of the genetic construct in reproducible manufacturing and the use of Master Cell Banks and Master Working Banks.
Dates - 22nd - 23rd May 2012, 30th - 31st October 2012
This course provides an introduction to the requirements of systematic failure investigation and corrective and preventive action practices as described in ICH Q9 and made a regulatory requirement in Europe by Annex 20 of the Guide to GMP and in the USA by the Federal Register/FDA Guidance for Industry. The course is focused on company responsibilities within a Quality Risk Management system and several investigational tools are explored to help build up knowledge of techniques that might be used by a company to provide a structure for systematic investigation of failure. Opportunities to try out simple techniques are provided throughout. Examples of the use of and outputs from more complex techniques are presented.
Dates - TBC
The course provides a detailed introduction into the clinical trials arena and explains
the key purposes, practices and principles involved. It introduces the legislation, standards and guidelines that impact on performing such trials. You will benefit from this course if you work in pharmaceutical R&D, have been newly appointed to clinical research or provide clinical supplies and other trial support services.
Dates - 3rd May 2012, 6th November 2012
Documentation is the cornerstone of any company’s Quality Management System and is an essential GMP requirement. It is critical that anyone dealing with GMP documents and documentation systems understand the regulatory requirements and adopts best practice. As such this course provides a step by step explanation of what to do when managing GMP Documentation and Documentation Systems and is appropriate to a wide ranging audience, from QA and QC, through to production and clinical trials professionals.
Dates - 30th May 2012, 12th December 2012
The course addresses environmental monitoring for the manufacturing of both sterile and non-sterile products. It looks at the legislation and guidance available, techniques employed to monitor pharmaceutical environments, data trending and how to manage out of limit results. Additionally a review of risks associated with contamination sources, monitoring methods, trending and reporting of results is undertaken. This course is aimed at personnel in production and quality functions who wish to increase their understanding of regulatory requirements and expectations for the environmental monitoring of pharmaceutical operations.
Dates - 20th March 2012, 12th July 2012, 11th December 2012
The course is designed to give background knowledge on the wide-ranging impact of microbiology on many aspects of pharmaceutical control. The course looks at the nature of micro-organisms, contamination sources and control, sterilization and disinfection, and testing methodology (including modern counting and identification techniques). The course will be of value to all personnel whose roles would benefit from a clearer understanding of this specialist area.
Dates - 20th September 2012
The course is based on the theory behind validation as specified and required by
European and USA guidelines. It explains what is required in order to ensure that
processes are operating to a safe and consistent standard. It covers the validation
approach, documentation, protocols, reports, change control and revalidation, and is
suitable for anybody working in the field of validation.
Dates - 21st March 2012, 4th October 2012
This course provides an extensive introduction to the regulatory requirements governing pharmaceutical Clean Room operation, and details the aseptic filling and terminal sterilization methods for producing sterile products. The delegates will gain an appreciation of the significance of sterile products to the patient, and understand why there is intensive regulatory interest in the control of sterile product manufacture. The course will be of value as underpinning knowledge to all personnel working for companies responsible for the manufacture of sterile products.
Dates - 27th March 2012, 25th October 2012
Efficient and effective plant cleaning is a vitally important aspect of pharmaceutical
manufacture. This entertaining and lively course is designed to highlight and explain the most important and fundamental issues associated with cleaning validation and verification – maximum allowable carryover calculations, documentation, cleaning validation master plans, good & bad practices, visual inspection, sampling & testing and analytical method validation.
Dates - 28th March 2012, 18th October 2012
Report writing requires many skills including planning, managing large quantities of information and the ability to get a message across to a non-technical audience. This course is for everyone who writes reports and would like to do it more efficiently, more confidently and with better results. A practical approach is taken and individuals receive feedback on their writing style.
Hazard Management using HACCP
Dates - 8 May 2012
Hazard Analysis and Critical Control Point (HACCP) principles have been used as the key tool for the management of product safety in the food industry for over 30 years, but its application within the pharmaceutical industry has been limited. HACCP principles provide a framework for the identification of significant hazards specific to a production process and their subsequent management. The importance of HACCP has been gaining momentum since the publication of ICH Q9 and the FDA GMPs for the 21st century which advocate risk management. The application of HACCP is considered to represent a very effective, logical and systematic approach to a requirement that can be daunting for those charged with completing the task.