Our wide range of Online Courses are listed below. Select 'More Details' to find out more about each course. ALL COURSES ARE IN ENGLISH.

March 2021

Online Course Title Start Date Start Times Duration

Pharmaceutical Water, Steam and Compressed Gas Systems

3-day course: Design, commissioning and qualification of pharmaceutical critical utility systems

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2nd March 2021 08:00 London/Dublin
09:00 Amsterdam/Berlin
3 days

Restricted Access Barrier Systems (RABS) & Isolator Technology

3-day course on the use of RABS and Isolator Technology in Aseptic Processing.

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9th March 2021 08:00 London/Dublin
09:00 Amsterdam/Berlin
3 days

Cleaning and Cleaning Validation

Equipment design for cleaning, effective cleaning, material carryover mechanisms and safe limits

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23rd March 2021 08:00 London/Dublin
09:00 Amsterdam/Berlin
3 days

April 2021

Online Course Title Start Date Start Times Duration

Aseptic Manufacturing of Pharmaceutical Products

Facility Design/Layout; Contamination Control; Risk Assessments; PST; Behaviours/Practices; EM

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13th April 2021 08:00 London/Dublin
09:00 Amsterdam/Berlin
3 days

Computer System Validation

Validation of computerised data management and equipment control systems

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20th April 2021 08:00 London/Dublin
09:00 Amsterdam/Berlin
3 days

May 2021

Online Course Title Start Date Start Times Duration

Pharmaceutical Equipment System Qualification

2-day course covering a risk based approach to Pharmaceutical Equipment System Qualification

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11th May 2021 08:00 London/Dublin
09:00 Amsterdam/Berlin
2 days

Pharmaceutical Process Validation

2-day course covering: Validation of Pharmaceutical and Bio-pharmaceutical Manufacturing Processes

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18th May 2021 08:00 London/Dublin
09:00 Amsterdam/Berlin
2 days

Understanding Pharmaceutical Sterilisation

3-day course: Sterilisation processes, equipment operation, maintenance/calibration and validation

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25th May 2021 08:00 London/Dublin
09:00 Amsterdam/Berlin
3 days

June 2021

Online Course Title Start Date Start Times Duration

Temperature Controlled Storage & Transportation of Pharmaceuticals (Includes COLD CHAIN)

Design, Qualification and Operation of Temperature Controlled Storage & Distribution Systems

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8th June 2021 08:00 London/Dublin
09:00 Amsterdam/Berlin
3 days

Pharmaceutical HVAC Systems

3-day course: HVAC system design, operation/maintenance, energy saving initiatives and qualification

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15th June 2021 08:00 London/Dublin
09:00 Amsterdam/Berlin
3 days

September 2021

Online Course Title Start Date Start Times Duration

Aseptic Manufacturing of Pharmaceutical Products

Facility Design/Layout; Contamination Control; Risk Assessments; PST; Behaviours/Practices; EM

7th September 2021 08:00 London/Dublin
09:00 Amsterdam/Berlin
3 days

Cleaning and Cleaning Validation

Equipment design for cleaning, effective cleaning, material carryover mechanisms and safe limits

14th September 2021 08:00 London/Dublin
09:00 Amsterdam/Berlin
3 days

Restricted Access Barrier Systems (RABS) & Isolator Technology

3-day course on the use of RABS and Isolator Technology in Aseptic Processing

28th September 2021 08:00 London/Dublin
09:00 Amsterdam/Berlin
3 days

October 2021

Online Course Title Start Date Start Times Duration

Pharmaceutical Water, Steam and Compressed Gas Systems

3-day course: Design, commissioning and qualification of pharmaceutical critical utility systems

5th October 2021 08:00 London/Dublin
09:00 Amsterdam/Berlin
3 days

Pharmaceutical HVAC Systems

3-day course: HVAC system design, operation/maintenance, energy saving initiatives and qualification

19th October 2021 08:00 London/Dublin
09:00 Amsterdam/Berlin
3 days

Pharmaceutical Equipment System Qualification

2-day course covering a risk based approach to Pharmaceutical Equipment System Qualification

26th October 2021 08:00 London/Dublin
09:00 Amsterdam/Berlin
2 days

November 2021

Online Course Title Start Date Start Times Duration

Pharmaceutical Process Validation

2-day course covering: Validation of Pharmaceutical and Bio-pharmaceutical Manufacturing Processes

2nd November 2021 08:00 London/Dublin
09:00 Amsterdam/Berlin
2 days

Computer System Validation

Validation of computerised data management and equipment control systems

9th November 2021 08:00 London/Dublin
09:00 Amsterdam/Berlin
3 days

Understanding Pharmaceutical Sterilisation

3-day course: Sterilisation processes, equipment operation, maintenance/calibration and validation

16th November 2021 08:00 London/Dublin
09:00 Amsterdam/Berlin
3 days

Temperature Controlled Storage & Transportation of Pharmaceuticals (Includes COLD CHAIN)

Design, Qualification and Operation of Temperature Controlled Storage & Distribution Systems

30th November 2021 08:00 London/Dublin
09:00 Amsterdam/Berlin
3 days

Recent Courses

A list of our recent pharmaceutical compliance and validation training courses is also provided below for your information.

Types of rouge, cause of rouge, control / prevention, monitoring and removal of rouge (2 hours) · Rouging is a disturbance of the naturally occurring passive layer of stainless steel, in effect an inversion of the passive layer rich in chromium-oxides to a porous layer rich in iron-oxides. This interactive online course will benefit anyone who is involved in the identification, risk assessment and management of rouge in pharmaceutical or bio-pharmaceutical facilities. This includes; production managers/supervisors, operators, maintenance technicians, engineers, quality assurance and validation personnel. Attendees will gain a detailed, practical understanding of what rouge is, how and why it forms, where it occurs and what problems this gives rise to. Attendees will learn about strategies to control and monitor rouge and methods that can be used to remove it. Speaker: John Welbourn
Materials and equipment requirements, procedures, analysis of results, causes of failure · Spray device coverage testing is a relatively straightforward method of establishing the surface wetting achieved by spray devices. The test often forms an important element of the equipment cleaning validation program. The course includes a description of the materials and equipment required, guidance on related health and safety considerations, an outline of a typical testing procedure, discussion on test results / examples of common causes of failure and discussion of the strategies that could be used to reduce the time and costs associated with testing. This course is aimed at individuals involved directly or indirectly in managing, performing or reviewing spray device coverage testing activities. Target disciplines include production (operators, supervisors and management), quality assurance, validation, technical support and engineering. Presenter: John Welbourn
Health based cleaning limits for pharmaceutical products, APIs, intermediates and cleaning agents · In order to safely operate manufacturing systems that produce multiple products using common product contact parts, it is critical to establish limits for the cleaning process that ensures the safety of the patients. Safe, scientifically justified, risk based and compliant limits will form the basis of the validation of cleaning process and ensure patient safety in terms limiting carryover from one product to another to safe acceptable levels. This course covers: material carry-over mechanisms / assumptions (linked to the theory of contamination and fundamental to calculating limits); establishing health based limits (HBELS) for pharmaceutical products (in accordance with EU guidance); limits for small molecule API’s an their intermediates and how to obtain limits for detergents. Pharmaceutical product and API limits. Also covered, is the conversion of total allowed carry limits to surface area limits related to swabbing areas + correcting limits for swab recovery performance. Worked examples will be included. The course is aimed at individuals involved directly or indirectly in establishing and operating to safe limits for cleaning processes. Target disciplines include validation, quality assurance, quality control, technical support, production (supervisors and management), and engineering. Presenter: Mike James
Moist/dry heat, autoclaves, sterilise in place (SiP), batch ovens, tunnels, types of cycles · This course provides an overview of the principal moist and dry heat sterilisation processes used in pharmaceutical and biopharmaceutical manufacturing, including types of equipment employed, such as porous and fluid load autoclaves, sterilise in place (SIP) systems, batch ovens and depyrogenation tunnels, typical routine controls and testing requirements, equipment qualification/requalification and process validation activities. The course discusses overkill or bioburden based cycle design and the rationale why either may be selected. This course is aimed at individuals involved directly or indirectly in managing, operating, qualifying and maintaining thermal sterilisation equipment or validating thermal sterilisation processes. Target disciplines include microbiology, production (operators, supervisors and management), quality assurance, validation, technical support and engineering. Presenter: John Welbourn
How particle counters work (assumptions/errors), classification and monitoring · Cleanroom classification is a fundamental qualification activity for pharmaceutical cleanrooms. It is the activity that demonstrates that your cleanrooms will achieve their designated Grade and associated particle limits specification under maximum occupancy and activity (it underpins maximum room occupancy). Leading on from this, it is essential that total non-viable monitoring is performed meaningfully to demonstrate continued performance of the cleanroom during routine operations. This course covers: how particle counters work and how to avoid under and over-sampling of larger particles (e.g. use of correctly sized and orientated isokinetic probes); setting up the classification exercise and incorporating ISO-14644 / EU Annex 1 / FDA Aseptic Processing Guide requirements (including the implications of the latest draft Annex 1); and effective particle monitoring (probe positioning by risk assessment). It does not cover microbial monitoring. A worked classification example will be included. The course is aimed at individuals involved directly or indirectly in carrying out classification and particle monitoring. Target disciplines include validation, quality assurance, production (supervisors and management) and engineering. Presenter: Mike James
Develop/scale the CSV activities based on risk, integration with equipment qualification, leveraging · This course provides an overview of automated (computerised) packaged systems and guidance and what characterises these types of system. The course presents a practical approach on how to develop and scale the Computer Systems Validation (CSV) activities based on risk assessment, and how to efficiently qualify systems by integrating CSV with equipment qualification and using risk based principals to leveraging commissioning in support of qualification where this is appropriate. The course includes practical worked examples. Individuals to benefit from attending this course include anyone involved with the compliance of automated packaged equipment systems. Target disciplines include production (operation, supervision and management), quality assurance, validation (people new to qualifying / verifying computerised systems), technical support and engineering. Presenter: John Welbourn
Classes of steam, key design aspects, qualification activities/requirements, testing/monitoring · This course provides guidance on qualification and routine testing of pure steam systems used in pharmaceutical and biopharmaceutical manufacturing. The course includes an overview of the principal classes of steam used with particular focus on pure steam. The course covers qualification requirements including; key design aspects; installation verification activities such as, materials, welding, line slopes and drawing checks; functional tests, such as load / diversity challenge and pressure regulation; performance tests, such as thermodynamic tests on the steam and quality tests on the steam condensate. The course also outlines requirements for routine control and monitoring of pure steam systems. It is aimed at individuals involved directly or indirectly in managing, operating, qualifying and maintaining pure steam systems. Target disciplines include production, quality assurance, validation, technical support and engineering. Presenter: John Welbourn
Importance of good line layout/design, risk assessments, equipment/process qualification, sampling. · Pharmaceutical packaging operations are key to: protecting the product from the environment during storage and transportation; ensure the product is correctly identified; ensuring the correct supporting information (leaflet); ensuring the product is genuine; protecting the patients; and projecting the manufacturing company’s image (artwork and free from cosmetic damage). This course covers: the importance of getting it right, control of packaging materials; the importance of good line layout/design; pack attributes and controlling parameters/devices; understanding the risks and risk assessments, factory acceptance testing, equipment qualification (installation and operational qualification); packing process performance qualification, challenges relating to serialization and sampling (qualification and routine). The course is aimed at individuals involved directly or indirectly in qualifying packaging systems/process. Target disciplines include validation, quality assurance, technical support, production (supervisors and management), and engineering. Presenter: Mike James
Risks, qualification activities/temperature mapping, reporting, ongoing operation · Ensuring that the correct storage conditions are maintained for drug products and raw materials is essential in assuring that product/materials are not damaged (reduced efficacy and/or increased degradant levels) and shelf-life information is still applicable. Get it wrong, and it could have serious consequences for the patient. This course is aimed at ensuring attendees are equipped with knowledge that will help them meet industry standards and regulatory expectations in the area of qualification, including effective temperature mapping of warehouses and large cold stores. Ultimately, this will demonstrate the ability of the facilities to store all material within the desired conditions. The course includes: getting the requirements correct (URS for new/modified facilities); Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), including key stages for mapping, for example critical monitoring locations (including example monitoring location maps); instrumentation and reporting; and operational considerations (including the use of Mean Kinetic Temperature [MKT] for assessing the impact of deviations). The course is aimed at individuals involved directly or indirectly in qualifying these facilities. Target disciplines include validation, quality assurance, technical support, storage facility operation staff (supervisors and management), and engineering. Presenter: Mike James
Classification/grading, qualification requirements, performance/routine testing, control · This course provides guidance on qualification and routine testing of Clean Compressed Air (CCA) and process gas systems used in pharmaceutical / biopharmaceutical manufacturing. The course includes an overview of the classification/grading of CCA and process gases. The course covers qualification requirements including; key design aspects; installation verification activities such as, materials, jointing, cleaning and drawing checks; functional tests, such as load / diversity challenge and filter integrity testing; performance tests, such as oil, moisture, non viable and viable particle testing. The course also outlines requirements for routine control and monitoring of CCA and process gas systems. It is aimed at individuals involved in managing, operating, qualifying and maintaining CCA and process gas systems. Target disciplines include production, quality assurance, validation, technical support and engineering. Presenter: John Welbourn
Types of rouge, cause of rouge, control / prevention, monitoring and removal of rouge (2 hours) · Rouging is a disturbance of the naturally occurring passive layer of stainless steel, in effect an inversion of the passive layer rich in chromium-oxides to a porous layer rich in iron-oxides. This interactive online course will benefit anyone who is involved in the identification, risk assessment and management of rouge in pharmaceutical or bio-pharmaceutical facilities. This includes; production managers/supervisors, operators, maintenance technicians, engineers, quality assurance and validation personnel. Attendees will gain a detailed, practical understanding of what rouge is, how and why it forms, where it occurs and what problems this gives rise to. Attendees will learn about strategies to control and monitor rouge and methods that can be used to remove it. Speaker: John Welbourn
Equipment design for cleaning, effective cleaning, material carryover mechanisms and safe limits · This 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 carry-over (contamination) mechanisms involved, which are pivotal to setting meaningful limits for maximum allowable carry-over [MACO] limits. The course also covers applicable regulatory rules & guidelines; demonstration of spray device coverage; methods for calculating MACO (for a wide range of residue types), based on health based exposure limits (HBELS) for highly hazardous and non-highly hazardous materials; methods for sampling/detecting/quantifying residues; and clean/dirty hold times. A matrix approach to cleaning validation for multi-product, non-dedicated equipment is also covered. Other areas covered are cleaning process monitoring/review, maintaining the validated state and dealing with common examples of cleaning issues that may arise during routine operation.
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 delegates 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 · Unlike many computer validation courses, this pharmaceutical online 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. The course has been been fully updated with the very latest guidance on DATA INTEGRITY by the FDA, MHRA and WHO. 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 supported by example test sheets and real-life examples.
3-day course on the use of Restricted Barrier Systems and Isolator Technology in Aseptic Processing. · This pharmaceutical online training course covers extensively the available technology and compliance solutions in the field of Isolator 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. The course will cover all implications of updates to EU Volume 4,Annex 1. A detailed approach to the optimisation and qualification of decontamination 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.
4-Day course on pharmaceutical process validation and equipment system qualification · This 4-day pharmaceutical training course is a combination of the 2-day Pharmaceutical Process Validation course and the 2-day Equipment System Qualification course. It is aimed at attendees who want to extend their knowledge of both equipment systems qualification and process validation. PLEASE NOTE: Attendees also have the option of booking on either one of the 2-day courses. Please refer back to course schedule - click on 'Back to More Courses...', below:
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 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 Continued Process Verification, together with critical GMP supporting systems are also covered by this course. PLEASE NOTE: There is an option of booking this course as a 4 day course, which includes the following Equipment System Qualification course. Please refer back to course schedule - click on 'Back to More Courses...', below:
2-day course covering a risk Based Approach to 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. PLEASE NOTE: There is an option of booking this course as a 4 day course, which includes the preceding Process Validation course. Please refer back to online course schedule - click on 'Back to More Courses...', below:
3-day course on: Design, commissioning and verification 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, 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. 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 (Annex 1 and Q & A's).
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.
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.
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.