Online Training Courses

2-day course covering: Validation of Pharmaceutical and Bio-pharmaceutical Manufacturing Processes · This online pharmaceutical validation training course provides attendees with a detailed appreciation of the full life cycle related to pharmaceutical and bio-pharmaceutical process validation. The course covers process validation for pharmaceutical and bio-pharmaceutical Active Pharmaceutical Ingredients (API’s), a variety of pharmaceutical product formulations and primary/secondary packing. The course includes areas such as: the concept of Operating Space, Design Space and Knowledge Space and how this relates to real life; typical process design considerations; the importance of correctly identifying critical quality attributes and the control parameters that influence / affect them (using risk assessment tools to help); quality by design and design of experiments; equipment / process control philosophy and maintaining process development traceability from laboratory through to pilot / scale-up studies and eventual production scale. A typical approach to the validation of packing operations is included, together with an overview of key regulations, guidelines and standards, including the latest FDA process validation guide and ICH Q8. Validation documentation requirements, sampling requirements, acceptable quality levels, management of deviations and Continued Process Verification, together with critical GMP supporting systems are also covered by this course. Attendees will receive PDF file versions of all the presentations by email. Presentations for each day will be sent out the day before the start of the respective day of the course.

3-Day Course: HVAC system design, operation/maintenance, energy saving initiatives and qualification · This 3-day training course provides attendees with an in-depth understanding of the key aspects of Heating Ventilation & Air Conditioning (HVAC) System design (designed in tandem with the facility), construction, operation and maintenance. It covers facility HVAC systems for a range of drug product types and APIs, including non-sterile drug products, for example oral solid dose/oral liquids, inhalation non-sterile products and aseptically manufactured products. Key considerations such as dust removal for safety and product quality protection are also covered by this course. One key focus of the course is how HVAC systems control critical room air attributes such as particle levels, temperature and relative humidity. Filtration, differential pressure cascades/control, room air change rates and the types of air mixing (turbulent versus unidirectional) are discussed in detail. To ensure this course is properly rounded, areas such as a risk based approach to the qualification of HVAC system equipment and the validation / qualification of environmental conditions, for sterile and non-sterile facilities, are carefully integrated into the course. The course also recognises the current drive towards energy savings / carbon emission reduction and includes useful information on how the energy usage of Pharmaceutical HVAC Systems can be correctly assessed and subsequently reduced by changing the operating philosophy (based on risk assessments) and making suitable modifications. This will be reinforced with the use of real-life examples. Attendees will receive PDF file versions of all the presentations by email. Presentations for each day will be sent out the day before the start of the respective day of the course.

3-day course covering a risk based approach to Pharmaceutical Equipment System Qualification · This pharmaceutical validation training course provides attendees with an in-depth appreciation of project life-cycle activities associated with equipment system qualification. These activities range from early project planning through to design review and qualification of critical aspects / components of manufacturing systems. A pivotal theme of the course is a risk-based approach to the qualification of manufacturing equipment systems, as defined under the ISPE baseline guides and ASTM E2500-20. As a result, System level Impact Assessments (System Classification), Component Criticality Assessments and the process of identifying critical aspects of manufacturing systems (System Risk Assessment). With an ever increasing regulatory expectation and requirement that the level of system / function testing is based on risk to product quality / patient safety and system complexity / novelty, a typical process used to achieve this goal is included in the course (Quality Risk Assessment). Also included, is how the integration of qualification with commissioning can minimise duplication of effort and maximise the use of supplier's documentation. Up-to-date information on current applicable regulatory and international standards / guidelines will be provided and 'real-life' examples will be used throughout the course. The course will be presented by individuals who have extensive and recent ‘hands-on’ knowledge and experience of the subject. Attendees will receive PDF file versions of all the presentations by email. Presentations for each day will be sent out the day before the start of the respective day of the course.

3-day course: Sterilisation processes, equipment operation, maintenance/calibration and validation · This course provides attendees with a rounded appreciation of all aspects of sterilisation, ranging from equipment design and process understanding, through to qualification and maintenance requirements. One key learning objective is to separate the facts from the myths and legends that are sometimes associated with sterilisation processes. This will help ensure that attendees focus on the important science based facts when making risk based decisions when they return to their daily jobs. Other learning objectives include equipping attendees with the correct knowledge to improve compliance, reducing potential regulatory issues, improving operation effectiveness and maximising the benefits/effectiveness of validation/qualification activities. The course will be presented by industry experts who collectively have worked in all areas relating to the operation and qualification of sterilisation equipment/processes. Their hands-on experience will provide current industry best practice and they will provide up-to-date regulatory authority information, including the latest EU Volume 4, Annex 1. Attendees will receive PDF file versions of all the presentations by email. Presentations for each day will be sent out the day before the start of the respective day of the course.

Facility Design/Layout; Contamination Control; Risk Assessments; APS; Behaviours/Practices; EM · The course covers one of the most challenging and high risk activities undertaken by the pharmaceutical and bio-pharmaceutical industry. To operate effectively in the field of aseptic manufacturing, it is essential to understand the sources/basic mechanisms of contamination in conjunction with the associated systems and procedures required to effectively control such contamination. This course provides attendees with an in-depth appreciation of contamination sources and mechanisms, together with effective controlling and monitoring mechanisms such as: good cleanroom operation; effective facility/HVAC system design, operation and maintenance; good aseptic behaviours/disciplines; effective personnel clothing systems, sterilisation processes, Aseptic Process Simulation (APS), risk management initiatives and environmental monitoring. All the latest regulatory requirements are built into the course's presentations. Attendees will receive PDF file versions of all the presentations by email. Presentations for each day will be sent out the day before the start of the respective day of the course.