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 2024

Online Course Title Start Date Start Times Duration

Pharmaceutical Process Validation

3-day course covering the validation of pharmaceutical and biopharmaceutical manufacturing processes

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20th March 2024 08:00 London/Dublin
09:00 Amsterdam/Berlin
3 days

May 2024

Online Course Title Start Date Start Times Duration

Understanding Pharmaceutical Packaging

Types of Packaging (materials/selection/testing) & Equipment, Security, and Qualification/Validation

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8th May 2024 08:00 London/Dublin
09:00 Amsterdam/Berlin
3 days

Understanding Pharmaceutical Sterilisation

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

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14th May 2024 08:00 London/Dublin
09:00 Amsterdam/Berlin
3 days

Pharmaceutical Equipment System Qualification

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

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21st May 2024 08:00 London/Dublin
09:00 Amsterdam/Berlin
3 days

September 2024

Online Course Title Start Date Start Times Duration

Cleaning and Cleaning Validation

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

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10th September 2024 08:00 London/Dublin
09:00 Amsterdam/Berlin
3 days

October 2024

Online Course Title Start Date Start Times Duration

Pharmaceutical HVAC Systems

3-Day Course: HVAC system design, operation/maintenance, energy saving initiatives and qualification

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8th October 2024 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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22nd October 2024 08:00 London/Dublin
09:00 Amsterdam/Berlin
3 days

November 2024

Online Course Title Start Date Start Times Duration

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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5th November 2024 08:00 London/Dublin
09:00 Amsterdam/Berlin
3 days

December 2024

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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3rd December 2024 08:00 London/Dublin
09:00 Amsterdam/Berlin
3 days

Recent Courses:

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Equipment design for cleaning, effective cleaning, material carryover mechanisms and safe limits · This course provides attendees with an in-depth appreciation of key design features of pharmaceutical and biopharmaceutical manufacturing equipment/systems to enable ‘easy’, effective cleaning (usually a far greater challenge than the validation). It also provides a detailed understanding of the approach to validating cleaning processes. This includes the fundamental understanding of material carryover (contamination) mechanisms and how this is pivotal to setting appropriate limits for acceptable levels of carryover (maximum allowable carryover [MACO] limits) from one product to another. The course also covers areas such as applicable regulatory rules & guidelines; demonstration of spray device coverage; methods for calculating MACO for large/small molecule compounds & cleaning agents); methods for sampling/detecting/quantifying residues (key considerations); inclusion of clean/dirty hold times in the validation study; the use of a matrix approach to multi-product non-dedicated equipment; cleaning process monitoring/review and maintaining the validated state. To help consolidate your learning, presentations will be supplemented by case studies and workshops. Attendees will receive PDF file versions of all the presentations by email. Presentations for each day will be sent out the day before the start of the respective day of the course.
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 return to their daily jobs. Other learning objectives include equipping attendees 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. Their hands-on experience will provide current industry best practice and they will provide up-to-date regulatory authority information, including the latest EU Volume 4, Annex 1. Attendees will receive PDF file versions of all the presentations by email. Presentations for each day will be sent out the day before the start of the respective day of the course.
3-day course: Design, commissioning and qualification 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, water for preparation of extracts and 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. Testing requirements (qualification and routine) are also covered. 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, including Annex 1 and the Q & A's for the production of water for injection using non-distillation methods. Attendees will receive PDF file versions of all the presentations by email. Presentations for each day will be sent out the day before the start of the respective day of the course.
Facility Design/Layout; Contamination Control; Risk Assessments; APS; 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 attendees 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, Aseptic Process Simulation (APS), risk management initiatives and environmental monitoring. All the latest regulatory requirements are built into the course's presentations. Attendees will receive PDF file versions of all the presentations by email. Presentations for each day will be sent out the day before the start of the respective day of the course.