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

September 2017

Course Title Start Duration Location

Pharmaceutical Critical Utility Systems

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

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26th September 2017 3 days Radisson Blu Hotel, Amsterdam

October 2017

Course Title Start Duration Location

Cleaning & Cleaning Validation (4 Day - Includes a Practical Day)

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

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3rd October 2017 4 days Radisson Blu Royal Hotel, Copenhagen

Cleaning & Cleaning Validation (3 Day)

Pharmaceutical equipment design, calculating limits and cleaning process validation

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4th October 2017 3 days Radisson Blu 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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17th October 2017 3 days Radisson Blu Royal Hotel, Copenhagen

November 2017

Course Title Start Duration Location

Aseptic Manufacturing of Pharmaceutical Products

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

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7th November 2017 3 days Radisson Blu Royal Hotel, Copenhagen

Computer System Validation

3-day course on the validation of computerised data management and equipment control systems

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7th November 2017 3 days Radisson Blu Hotel, Amsterdam

Pharmaceutical HVAC Systems

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

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14th November 2017 3 days Radisson Blu Royal Hotel, Copenhagen

Understanding Pharmaceutical Sterilisation

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

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21st November 2017 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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28th November 2017 3 days Radisson Blu Hotel, Amsterdam

February 2018

Course Title Start Duration Location

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

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

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27th February 2018 3 days Radisson Blu Sisli Hotel, Istanbul

Recent Courses

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

AMSTERDAM COURSE FULL 2-day course covering: Risk Based Approach to Equipment System Qualification · Sorry, this course is now fully booked. There are still places available on the 2-Day Process Validation Course. 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 COURSE FULL!! 4-Day course on pharmaceutical process validation and equipment system qualification · Sorry this course is now fully booked. There are still places available on the 2-Day Process Validation Course 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.
AMSTERDAM 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.