Current Requirements for Cleaning Validation
This course covers topics such as the development of regulatory expectations, effective cleaning procedures and the validation and control of these procedures. For those new to this area, this course provides a detailed and structured introduction to cleaning validation, whilst for those who have been working in the field for some time this up to the minute course will provide details of current best practice, cGMP expectations, industry trends and regulatory issues for both the EU and US markets. 50% of the time will be spent in lectures and 50% of the course will be spent performing practical exercises and in interactive workshops.
Cleanrooms: Principles in Practice®
The Cleanrooms: Principles in Practice® course provides a holistic view of the design, operation and management of cleanrooms and is suitable for all personnel who work in or manage a cleanroom environment. As leading consultants in sterile process manufacturing, terminal sterilisation and aseptic production, the Honeyman Group have a wealth of experience in the design, build, validation and ongoing monitoring of cleanrooms. Working with many of the world’s leading pharmaceutical and medical device manufacturers, the Honeyman Group are currently involved with a number of cleanroom design projects encompassing feasibility studies, design and build specifications and risk assessments. The Honeyman Group’s Analytical Services Laboratory works with a number of clients to evaluate, advise upon and develop ongoing environmental monitoring, cleaning validation and disinfectant efficacy programmes.
The course has been developed by industry experts in cleanroom design, cleanroom validation, microbiology and quality assurance. The most effective way of understanding clean room operations is to be involved in hands on exercises, demonstrations and workshops, therefore this course consists of 50% lectures and 50% practical.
Pharmaceutical Microbiology for Non-Microbiologists
Controlling microbiology throughout the manufacturing process is a key success factor for production. Microbiology is unseen and data is history, effective control requires all disciplines to be involved in the control measures and any out of specification investigations. Therefore, all key personnel should have a thorough understanding of microbiology. This course is designed to give non-microbiologists a comprehensive introduction to microbiology so that they can engage in the required control measures, investigations and corrective actions.
This two-day course combines classroom based lectures with practical workshops in our approved MHRA laboratory and aims to give delegates a solid introduction to microbiology in the context of pharmaceutical manufacture. Throughout the course, data interpretation will be practised and the consequences of misinterpretation discussed.
Pharmaceutical Sterilisation: Principles in Practice®
According to the EU GMP Guide Annex 1, the manufacture of sterile products is subject to special requirements in order to minimise the risks of contamination, with much depending on the skill, training and attitudes of the personnel involved. In particular, managing sterilisation processes is critical to the manufacture of both terminally sterilised and aseptically prepared products.
The Pharmaceutical Sterilisation: Principles in Practice® course provides delegates with a comprehensive understanding of moist heat and dry heat sterilisation processes from theoretical foundation through to the practical aspects of validation and biological indicators. The course highlights the GMP requirements and current industry expectations for the routine operation, monitoring and control of sterilisation processes and gives practical examples of how these techniques are applied through appropriate engineering to ensure reliability in full compliance with all European and
Pharmaceutical Water Systems: Principles in Practice®
This course highlights the key and essential points of designing, building, owning and operating pharmaceutical water systems. Basic design of water purification, storage and distribution system elements will be outlined, with illustrated examples. Delegates from different backgrounds and disciplines such as Engineering QC/Microbiology, Validation, Plant and Production Operators will learn and understand the roles each plays in the management, maintenance and control of water systems. Good communication and understanding between these areas is of course essential and key to efficient and successful water system performance.
Microbial Risk Management During Cleanroom Operations
The Risk Management of Contamination (RMC) system is a systematic approach to the management of contamination. The system identifies microbial risks to a product, assesses the extent of the risk and where necessary, reduces it. The identified risks, or their methods of control, are monitored and limits established to ensure that contamination is correctly controlled. The system is then verified on a continuing basis to ensure that it is working effectively. Associated documentation and training requirements are also an important stage of this system.
Good Engineering Practice
Over the last 10 years there has been a significant change in the way pharmaceutical products are developed and manufactured, therefore we now have a regulatory framework which is focussed on risk based pharmaceutical manufacture. Good Engineering Practice (GEP) has been highlighted as being an integral part of the quality system in standards like ASTM E2500 along with risk management, design review, change management and continuous improvement. The approach to verification of equipment and facilities is changing with many companies taking the opportunity to redefine GEP in their QMS and their approach to validation, to focus on critical activities and avoid unnecessary repetition of testing during lifecycle activities.
Engineers from all disciplines play a key role in the development and manufacture of pharmaceutical products, with involvement in the specification, design, verification and subsequent maintenance of the facilities, utilities and equipment necessary for the various stages of production. There is now the opportunity for engineers to become Subject Matter Experts and take a lead role in risk based decision making throughout lifecycle activities and take a more prominent role during all stages of production and inspections.
With this progression in GEP philosophy, and "system experts" playing a much more significant role in pharmaceutical processes and projects, never has the need been greater for knowledgeable engineers to be an integrated part of all pharmaceutical manufacturing and project processes. Based on current "real world" experiences, this course will highlight how current GMP’s are applied to pharmaceutical engineering and technical services to ensure facilities, equipment and processes are maintained to the correct standard as efficiently as possible.
Critical Factors for Sterile Product Manufacture
The manufacture of sterile products is subject to special controls and relies heavily in the competency and knowledge of everyone involved in the process. This course covers all key aspects of sterile product manufacture, for both aseptically prepared and terminally sterilised products. Whether involved in production,
QC Laboratories: Principles in Practice®
This course is designed to provide guidance on why GMP applies to a laboratory, which regulations apply, how to manage the essential quality management systems, and what to expect if you do not comply. The course provides guidance on a range of topics from design of the laboratory, calibration and validation to management of technical agreements, out of specification results and data integrity.
Self-Inspection & Auditor Training
This course is designed to provide guidance on how to set up and manage a self-inspection programme which meets the requirements of GMP. Effective management of self-inspections reduces the risk of serious non-conformities and provides a firm base from which to build a good quality management system. Having good control of your self-inspection program will minimise resource required for responses to deficiencies issued by your health authority inspector, internal investigations and corrective actions.
In addition, this course will provide delegates with the skills to audit both external customers and internal departments. Both soft skills and wide understanding of a quality management system are required in order to comply with EU guidance and GMP.
Biotechnology and the Future
This course provides a comprehensive overview of biotechnology ideology and practice, historically, as we are now, and expected developments in the future.
Biotechnology is a wide field and we will be looking at basic principles, concentrating on the production and development of a single processing route that encompasses the key techniques, materials and requirements involved in producing a range of products. In addition to the actual processes involved, this course will include guidance on validating, verifying and quantifying the techniques and systems in operation in order to maximise quality and consistency.
The course is spread over two days to allow interaction between the lecturer and attendees. The presentations will be supplemented with workshops that will be used to verify understanding and look at the biotechnology industry and its future.
This course itself will encourage discussion and participation which will lead to greater understanding of the current status of biotechnology and the future of the industry.