| Cleaning and Cleaning Validation |
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| Pharmaceutical equipment design (for cleaning), calculating limits, cleaning process validation · This pharmaceutical training course covers key design features of pharmaceutical and biopharmaceutical manufacturing equipment/systems to enable effective, ‘easy’ cleaning and provides a detailed understanding of the approach to validating cleaning processes. This includes understanding the material carryover (contamination) mechanisms involved, which are pivotal to setting meaningful limits for maximum allowable carryover [MAC] limits. The course also covers applicable regulatory rules & guidelines; demonstration of spray device coverage; methods for calculating MAC (wide range of residue types); methods for sampling/detecting/quantifying residues; clean/dirty hold times; matrix approach to multi-product non-dedicated equipment; cleaning process monitoring/review and maintaining the validated state. |
| Computer System Validation |
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| Validation of computerised data management (business) and control systems - A practical approach · Unlike many computer validation courses, this pharmaceutical training course concentrates on what actually works in real life with respect to the quality management, operation and qualification of computerised data management (business) systems and equipment control systems. This will be supported by the high level of relevant and recent practical knowledge of the presenters involved.The first part of the course covers the general theory and terminology relating to the validation phases and will encompass current applicable regulatory rules/guidance and international standards/guidelines (including GAMP 5). It will also cover the operational and quality management activities relating to: routine operation/management; system/process/validation review; data management and system retirement. A full set of example procedures and templates will be provided for the areas covered under this section of the course.The second and major part of the course will be dedicated to working through, in a very practical way, qualification activities/testing relating to key areas of computerised systems such as: infrastructure qualification/verification; packaged system qualification/verification; IS Systems (data management systems); and plant /equipment control systems. This will be heavily supported by example test sheets and real-life examples. |
| Equipment System Verification / Qualification |
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| A Risk Based approach to Pharmaceutical Equipment System Verification / Qualification · This pharmaceutical validation training course provides delegates 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 E2500-07. 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. |
| Equipment System Verification / Qualification and Process Validation |
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| Combined course: 2-Day Equipment System Verification / Qualification + 2-Day Process Validation · This pharmaceutical training course is a combination of both the 2-day Equipment System Verification/Qualification course and the 2-day Process Validation Training Courses.It is aimed at delegates who want to extend their knowledge of both equipment systems qualification and process validation.Delegates also have the option of booking on either of the 2-day courses.Please see overviews for each of the 2-day courses for more details. |
| Pharmaceutical Cold Chain & Storage Conditions Qualification |
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| Cold Chain Management, Design/Construction/ Qualification of Storage Facilities/Distribution Systems · This pharmaceutical training course not only covers the fundamental considerations, challenges and solutions for effective cold chain management, it goes that one stage further and gives delegates an in-depth appreciation of the key design/construction considerations and attributes of storage facilities and distribution systems, together with practical strategies and techniques for validating the systems involved. Included within the scope of this course are areas such as: key regulatory rules and guidance; key guidance and instructions from international organisations; design and qualification of storage systems from ‘bench’ type through to large storage facilities; cold box qualification for range of climatic conditions (rationalising qualification strategy); vehicle design and qualification; monitoring systems (including qualification); risk management and key qualification document considerations. |
| Pharmaceutical Critical Utility Systems |
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| Design, commissioning and qualification/verification of pharmaceutical critical utility systems · The 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, highly purified water, 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. 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. |
| Pharmaceutical HVAC Systems |
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| Pharmaceutical HVAC system design, operation, energy saving, maintenance and qualification · This pharmaceutical training course provides delegates 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, ATmosphere EXplosibles (ATEX) compliance are also covered by this course. 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. |
| Pharmaceutical Process Validation |
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| Validation of Pharmaceutical and Biopharmaceutical Manufacturing Processes · This pharmaceutical validation training course provides delegates with a detailed appreciation of the full life cycle related to pharmaceutical and biopharmaceutical process validation. The course covers process validation for pharmaceutical and biopharmaceutical 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 secondary 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 maintaining the validated state, including revalidation are also covered by this course. |
| RABS & Isolator Technology |
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| The use of Restricted Barrier Systems (RABS) and Isolator Technology in Aseptic Processing. · This pharmaceutical training course covers the A-Z of Isolator Technology and Restricted Access Barrier Systems (RABS) used in Aseptic Manufacturing.The course also covers barrier system design and selection, covering areas such as: the risk of product contamination and the subsequent risk to patient; the types of systems available; ergonomics; types of sanitisation systems, e.g. vapour phase hydrogen peroxide (VPHP); air-handing system requirements, pressure regimes, device/surrounding area classification; monitoring systems; and the overall advantages and disadvantages of using Isolators or RABS over traditional Aseptic Manufacturing (advanced aseptic processing versus standard Grade A to B interfaces). It also provides an overview of all key applicable guidelines, standards and regulations, and will cover the origins (myths, legends and science) behind the standards currently used.A detailed approach to the optimisation and qualification of sanitisation cycles will be included, together with requirements for operation, maintenance, testing, inspection and monitoring of the systems and environments involved. The course is heavily orientated towards basing decisions for design, qualification/verification, operation and routine monitoring/testing/inspection on risk to product quality and ultimately risk to patient. |
| RABS & Isolator Technology |
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| The Use of Restricted Barrier Systems (RABS) and Isolator Technology in Aseptic Processing. · This pharmaceutical training course covers the A-Z of Isolator Technology and Restricted Access Barrier Systems (RABS) used in Aseptic Manufacturing.The course also covers barrier system design and selection, covering areas such as: the risk of product contamination and the subsequent risk to patient; the types of systems available; ergonomics; types of sanitisation systems, e.g. vapour phase hydrogen peroxide (VPHP); air-handing system requirements, pressure regimes, device/surrounding area classification; monitoring systems; and the overall advantages and disadvantages of using Isolators or RABS over traditional Aseptic Manufacturing (advanced aseptic processing versus standard Grade A to B interfaces). It also provides an overview of all key applicable guidelines, standards and regulations, and will cover the origins (myths, legends and science) behind the standards currently used.A detailed approach to the optimisation and qualification of sanitisation cycles will be included, together with requirements for operation, maintenance, testing, inspection and monitoring of the systems and environments involved. The course is heavily orientated towards basing decisions for design, qualification/verification, operation and routine monitoring/testing/inspection on risk to product quality and ultimately risk to patient. |
| Understanding Pharmaceutical Sterilisation |
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| Sterilisation Processes and Equipment Operation, Maintenance/Calibration and Validation. · This course provides delegates 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 separator out 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 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. |