Online Training Courses

3-day course: Design, commissioning and qualification of pharmaceutical critical utility systems · This pharmaceutical training course covers current and best practice in the areas of design, construction and commissioning / qualification of critical utility systems. It includes generation and distribution systems for purified water, water for preparation of extracts and water for injection (WFI), clean steam, pure steam, compressed air and process gases. The course provides an insight into the underlying hygienic design principles/requirements/guidance involved in the specification, construction and completion of these systems. Testing requirements (qualification and routine) are also covered. It also provides information on suitable system design solutions and configuration, together with a detailed systematic approach to the key stages (including planning) involved in the project life-cycle. Typical examples of operational issues and recommended actions/precautions that can be taken, are also covered by this course. The course will be fully updated to reflect requirements from the latest pharmacopoeias and EMA regulatory guidelines, including Annex 1 and the Q & A's for the production of water for injection using non-distillation methods.

3-day course on the use of RABS and Isolator Technology in Aseptic Processing. · This course covers the design, installation, qualification and operation of isolator systems and restricted access barrier systems (RABS), as used in aseptic manufacturing. It looks at the choices of systems available and the advantages and disadvantages of using Isolators and RABS over traditional Aseptic Manufacturing. The course also covers system design (types of systems, ergonomics, air classification and air-flow requirements) and the qualification / verification of the equipment systems involved, including facility and HVAC systems for isolators/RABS and surrounding/supporting areas. Also included in the course, is the development, optimisation and qualification of sporicidal decontamination cycles, together with requirements for operation, maintenance, testing, inspection and monitoring of the systems and environments involved. The impact of any changes to EU Annex 1 on the design and operation of RABS/isolator systems will be discussed, together with the latest developments in gloveless automated isolators.

Equipment design for cleaning, effective cleaning, material carryover mechanisms and safe limits · This course provides attendees with an in-depth appreciation of key design features of pharmaceutical and biopharmaceutical manufacturing equipment/systems to enable ‘easy’, effective cleaning (usually a far greater challenge than the validation). It also provides a detailed understanding of the approach to validating cleaning processes. This includes the fundamental understanding of material carryover (contamination) mechanisms and how this is pivotal to setting appropriate limits for acceptable levels of carryover (maximum allowable carryover [MACO] limits) from one product to another. The course also covers areas such as applicable regulatory rules & guidelines; demonstration of spray device coverage; methods for calculating MACO for large/small molecule compounds & cleaning agents); methods for sampling/detecting/quantifying residues (key considerations); inclusion of clean/dirty hold times in the validation study; the use of a matrix approach to multi-product non-dedicated equipment; cleaning process monitoring/review and maintaining the validated state. To help consolidate your learning, presentations will be supplemented by case studies and workshops.

Facility Design/Layout; Contamination Control; Risk Assessments; PST; 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, process simulation trials, risk management initiatives and environmental monitoring.

Validation of computerised data management and equipment control systems · This course provides attendees with up-to-date and detailed information that should help them tackle the many diverse challenges of validating and operating computerised systems in a compliant and risk based way. The course aims to cover all the key areas that need to be considered when qualifying and operating computerised systems. These include: the types of computer/computerised systems and their elements; key regulations and guidance; data management and data integrity; the general principles of risk based validation; validation planning/approaches/activities; supplier governance; data migration; current trends; operational phase activities; infrastructure management; and periodic system review. It will also include an example infrastructure project and the qualification of: Packaged Systems (Equipment Control Systems); Distributed Control Systems; Laboratory Systems; Information/Business Systems and Spreadsheets. The presentations will include real life examples and the learning experience will be enhanced by using carefully structured workshops.

2-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 verification / qualification. These activities range from early project planning through to design review and verification / qualification of critical aspects / components of manufacturing systems. A pivotal theme of the course is a risk-based approach to verification / qualification of manufacturing equipment systems, as defined under the ISPE baseline guides and ASTM E2500-13. As a result, System level Impact Assessments, Component Criticality Assessments and the process of identifying critical aspects of manufacturing systems during the design phase are covered in detail. 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 verification / 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.

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.

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 resume their normal job related activities. Other learning objectives include equipping delegates 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.

Design, Qualification and Operation of Temperature Controlled Storage & Distribution Systems · This live online pharmaceutical training course has been tailored to cover a typical life-cycle approach to the design, qualification and operation of temperature controlled storage and distribution systems. Systems, facilities and equipment have been placed into logical groups, which will be taken through their respective life-cycle (design, qualification and operation). The course aims to cover as many types of systems involved in the storage and distribution of drug products as practicable in the allotted time (controlled temperature and cold chain), taking care not to overload the information. The course includes new sections on operational considerations for each system/facility/equipment group, with ongoing risk management, continuous improvement, data reporting/management and dealing with non-conformance, e.g. failure to include shipment loggers, lost loggers and logger failure. So to sum up the course, we take people through system/equipment/facility design + selection for compliant and consistent operation, how to qualify the systems/equipment/facilities (with example approaches) and then through ongoing operational considerations for compliant and consistent operation.

3-day course: HVAC system design, operation/maintenance, energy saving initiatives and qualification · This live online pharmaceutical 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.

Facility Design/Layout; Contamination Control; Risk Assessments; PST; 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, process simulation trials, risk management initiatives and environmental monitoring.

Equipment design for cleaning, effective cleaning, material carryover mechanisms and safe limits · This course provides attendees with an in-depth appreciation of key design features of pharmaceutical and biopharmaceutical manufacturing equipment/systems to enable ‘easy’, effective cleaning (usually a far greater challenge than the validation). It also provides a detailed understanding of the approach to validating cleaning processes. This includes the fundamental understanding of material carryover (contamination) mechanisms and how this is pivotal to setting appropriate limits for acceptable levels of carryover (maximum allowable carryover [MACO] limits) from one product to another. The course also covers areas such as applicable regulatory rules & guidelines; demonstration of spray device coverage; methods for calculating MACO for large/small molecule compounds & cleaning agents); methods for sampling/detecting/quantifying residues (key considerations); inclusion of clean/dirty hold times in the validation study; the use of a matrix approach to multi-product non-dedicated equipment; cleaning process monitoring/review and maintaining the validated state. To help consolidate your learning, presentations will be supplemented by case studies and workshops.