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

September 2020

Online Course Title Start Date Start Times Duration

Computer System Validation (3 Day)

Validation of computerised data management and equipment control systems

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22nd September 2020 08:00 London/Dublin
09:00 Amsterdam/Berlin
3 days

RABS & Isolator Technology (3 Day)

3-day course on the use of Restricted Barrier Systems and Isolator Technology in Aseptic Processing.

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29th September 2020 08:00 London/Dublin
09:00 Amsterdam/Berlin
3 days

October 2020

Online Course Title Start Date Start Times Duration

Pharmaceutical Process Validation & Equipment System Qualification (4-Day)

4-Day course on pharmaceutical process validation and equipment system qualification

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13th October 2020 08:00 London/Dublin
09:00 Amsterdam/Berlin
4 days

Pharmaceutical Process Validation (2-Day)

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

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13th October 2020 08:00 London/Dublin
09:00 Amsterdam/Berlin
2 days

Pharmaceutical Equipment System Qualification (2-Day)

2-day course covering a risk Based Approach to Equipment System Qualification

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15th October 2020 08:00 London/Dublin
09:00 Amsterdam/Berlin
2 days

Pharmaceutical Water, Steam and Compressed Gas Systems (3 Day)

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

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20th October 2020 08:00 London/Dublin
09:00 Amsterdam/Berlin
3 days

November 2020

Online Course Title Start Date Start Times Duration

Understanding Pharmaceutical Sterilisation

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

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3rd November 2020 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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17th November 2020 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.

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....
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
Criteria for use of a matrix, identification of marker compound(s), number of runs, hold-times · Applying full cleaning validation for every product changeover on multi-product (non-dedicated) pharmaceutical manufacturing equipment can be very time consuming, expensive and pretty pointless, if you have a common cleaning procedure for all/groups of products. Applying a risk based matrix approach, where the cleaning process is validated for the most toxic and least soluble compound (marker compound), optimizes the cleaning validation process and also demonstrates that you understand your products, the residues they leave and the cleaning process itself (other factors such as the most difficult to clean, based on the nature of the residues remaining, may also be considerations). This course covers: assessing your product mix and potential residues (before and after cleaning); applying a risk based approach to marker compound selection; applying limits for residues, determining the number of cleaning runs required and incorporation of clean and dirty hold times. Worked examples will be included. The course is aimed at individuals involved directly or indirectly in establishing a matrix approach to cleaning validation. Target disciplines include validation, quality assurance, technical support and production (supervisors and management). 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.