Our wide range of Hotel Based (Open) courses are listed below. Select 'More Details' to find out more about each course.

September 2018

Course Title Start Duration Location

Cleaning & Cleaning Validation (4-Day - Day 1 is a Practical Day)

Pharmaceutical equipment design, calculating limits, cleaning process validation and practical demo

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11th September 2018 4 days Radisson Collection Royal Hotel, Copenhagen

Cleaning & Cleaning Validation (3-Day)

Pharmaceutical equipment design for cleaning, calculating limits and cleaning process validation

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12th September 2018 3 days Radisson Collection Royal Hotel, Copenhagen

RABS & Isolator Technology

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

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18th September 2018 3 days Radisson Collection Royal Hotel, Copenhagen

October 2018

Course Title Start Duration Location

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

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

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2nd October 2018 4 days Radisson Blu Hotel, Amsterdam

Pharmaceutical Process Validation (2-Day)

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

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2nd October 2018 2 days Radisson Blu Hotel, Amsterdam

Pharmaceutical Equipment System Qualification (2-Day)

2-day course covering: Risk Based Approach to Equipment System Qualification

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4th October 2018 2 days Radisson Blu Hotel, Amsterdam

Aseptic Manufacturing of Pharmaceutical Products

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

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9th October 2018 3 days Marriott Hotel, Copenhagen

Computer System Validation

Validation of computerised data management and equipment control systems.

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16th October 2018 3 days Radisson Blu Hotel, Amsterdam

Pharmaceutical Critical Utility Systems

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

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30th October 2018 3 days Radisson Blu Hotel, Amsterdam

November 2018

Course Title Start Duration Location

Pharmaceutical HVAC Systems

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

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6th November 2018 3 days Marriott Hotel, Copenhagen

Understanding Pharmaceutical Sterilisation

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

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20th November 2018 3 days Radisson Blu Hotel, Amsterdam

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

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

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27th November 2018 3 days Radisson Blu Hotel, Amsterdam

Recent Courses

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

COPENHAGEN Validation of computerised data management and equipment control systems. · 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. As part of the overall course package, each delegate will receive a comprehensive set of example quality management procedures and templates for computer systems. They will also receive a copy of an up-to-date Data Governance procedure that addresses all the data integrity requirements. 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 heavily supported by example test sheets and real-life examples.
COPENHAGEN 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).
COPENHAGEN V 2-day course covering: Risk Based Approach to Equipment System 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 E2500-13. 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 course schedule - click on 'Back to More Events...', at the bottom of this web page.
AMSTERDAM 3-day course: HVAC system design, operation/maintenance, energy saving initiatives 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 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.
COPENHAGEN V 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 delegates who want to extend their knowledge of both equipment systems qualification and process validation. PLEASE NOTE: Delegates 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 Events...', at the bottom of this web page.
COPENHAGEN V 2-day course covering: 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 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 Verification course. Please refer back to course schedule - click on 'Back to More Events...', at the bottom of this web page.
AMSTERDAM 3-day course on the use of Restricted Barrier Systems 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. The course will cover all implications of updates to EU Volume 4, Annex 1. 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.
COPENHAGEN V Both 3 and 4 Day Options are available in September - See below · This course starts with a practical day at Alfa Laval's vessel cleaning development facility at Ishøj, approximately 14km from the venue hotel. Transport will provided to and from the venue hotel (Radisson Blu Royal Hotel) at 9:30 in the morning with a 16:30 return. Here, delegates will be able to see and hear different types of spray devices operating in a real environment and witness the pros and cons of different types of devices. Coverage trials and TOC swabbing will also be demonstrated. The theory part of the course (Wednesday to Friday, inclusive) 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. PLEASE NOTE: This course can also be booked as a 3 day option (Hotel Based). Please refer back to course schedule - click on 'Back to More Events...', at the bottom of this web page.
COPENHAGEN V Both 3 and 4 Day Options are available in September - See Below · 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. PLEASE NOTE: There is an option of booking this course as a 4 day course, which includes a practical day at a vessel cleaning development facility (Tuesday 20th March 2018). Please refer back to course schedule - click on 'Back to More Events...', at the bottom of this web page.
COPENHAGEN SORRY: THIS COURSE HAS BEEN MOVED TO 29 MAY 2018, BECAUSE OF SPEAKER AVAILABILITY. · Many apologies for having to move this course. Please click the 'Back to More Events' link at the bottom of this section to view the rearranged course (29 May 2018).
AMSTERDAM FULL!! Facility Design/Layout; Contamination Control; Risk Assessments; PST; Behaviours/Practices · SORRY THIS COURSE IS FULL - It will be run again on the 9th October 2018, Copenhagen Marriott, Denmark. The course covers one of the most challenging and high risk activities undertaken by the pharmaceutical and biopharmaceutical 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.
COPENHAGEN Design, Qualification and Operation of Temperature Controlled Storage & Distribution Systems · THIS COURSE HAS BEEN BROUGHT FORWARD BY 1-WEEK DUE TO SPEAKER AVAILABILITY (ORIGINALLY SCHEDULED FOR 5 JUNE 2018). APOLOGIES FOR ANY INCONVENIENCE THIS MAY HAVE CAUSED. This course has been restructured to follow 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.
COPENHAGEN 3-day course:Sterilisation processes, 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 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 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.