All courses are presented in English.

March 2024

Course Title Start Duration Location

Computer System Validation

Validation of computerised data management and equipment control systems

View the PDF Document Download Course Brochure

Course Delivered Hotel Scandic Copenhagen

Restricted Access Barrier Systems (RABS) & Isolator Technology

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

View the PDF Document Download Course Brochure

12th March 2024 3 days Hotel Scandic Copenhagen

April 2024

Course Title Start Duration Location

Pharmaceutical HVAC Systems

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

View the PDF Document Download Course Brochure

16th April 2024 3 days Hotel Scandic Copenhagen

Cleaning and Cleaning Validation (Including a Practical Day)

Effective equipment design/cleaning; safe/science based limits; cleaning technology demonstration

View the PDF Document Download Course Brochure

23rd April 2024 4 days Comwell Kolding Hotel, Denmark

June 2024

Course Title Start Duration Location

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

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

View the PDF Document Download Course Brochure

11th June 2024 3 days Hotel Scandic Copenhagen

September 2024

Course Title Start Duration Location

Aseptic Manufacturing of Pharmaceutical Products

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

View the PDF Document Download Course Brochure

3rd September 2024 3 days Hotel Scandic Copenhagen

Pharmaceutical Water, Steam and Compressed Gas Systems

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

View the PDF Document Download Course Brochure

17th September 2024 3 days Hotel Scandic Copenhagen

October 2024

Course Title Start Duration Location

Pharmaceutical Equipment System Qualification

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

View the PDF Document Download Course Brochure

1st October 2024 3 days Hotel Scandic Copenhagen

Pharmaceutical Process Validation

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

View the PDF Document Download Course Brochure

15th October 2024 3 days Hotel Scandic Copenhagen

November 2024

Course Title Start Duration Location

Understanding Pharmaceutical Packaging

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

View the PDF Document Download Course Brochure

19th November 2024 3 days Hotel Scandic Copenhagen

Understanding Pharmaceutical Sterilisation

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

View the PDF Document Download Course Brochure

26th November 2024 3 days Hotel Scandic Copenhagen

Recent Courses:

.

COPENHAGEN 3-day course covering a risk based approach to Pharmaceutical Equipment System Qualification · This pharmaceutical validation training course provides delegates with an in-depth appreciation of project life-cycle activities associated with equipment system qualification. These activities range from early project planning through to design review and qualification of critical aspects / components of manufacturing systems. A pivotal theme of the course is a risk-based approach to the qualification of manufacturing equipment systems, as defined under the ISPE baseline guides and ASTM E2500-20. As a result, System level Impact Assessments (System Classification), Component Criticality Assessments and the process of identifying critical aspects of manufacturing systems (System Risk Assessment). 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 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. Delegates will be provided with a 3-slide per page printed binder upon arrival on Day 1 and PDF versions of the slides will be sent out by email to each delegate after the course. Day-time meals and refreshments, together with a course dinner, held on the evening of Day 1 (Tuesday 21 Nov 2023), are included in the overall package.