Compliance and Validation Training Courses

KOLDING Effective equipment design/cleaning; safe/science based limits; cleaning technology demonstration · This course provides delegates 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 learning, presentations will be supplemented by case studies and workshops This course incorporates a Practical Day, which will be held at Alfa Laval’s Application & Innovation Centre, Kolding, Denmark (transport included) and will help strengthen learning from the first 2-days of the of hotel based training. During this day, delegates will be presented with information on the dynamics of fluid flow in cleaning applications. There will be demonstrations of how coverage can be verified (using Riboflavin). Further demonstrations will show how different types of spray devices perform when cleaning a challenging residue. Swabbing and TOC analysis will also be covered. 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 23 Apr 2024), are included in the overall package.

COPENHAGEN Validation of computerised data management and equipment control systems · This course provides delegates with up-to-date and detailed information that should help them tackle the many diverse challenges of validating and operating computerised systems in a compliant and risk based way. The course aims to cover all the key areas that need to be considered when qualifying and operating computerised systems. These include: the types of computer/computerised systems and their elements; key regulations and guidance (including GAMP 5 2nd Edition [2022]); data management and data integrity; the general principles of risk based validation; validation planning/approaches/activities; supplier governance; data migration; current trends; operational phase activities; infrastructure management; and periodic system review. It will also include an example infrastructure project and the qualification of: Packaged Systems (Equipment Control Systems); Distributed Control Systems; Laboratory Systems; Information/Business Systems and Spreadsheets. The presentations will include real life examples and the learning experience will be enhanced by using carefully structured workshops. 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 5 Mar 2024), are included in the overall package.

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.

Pharma HVAC Systems - CONVERTED TO AN ONLINE COURSE · Please note: This course has now been converted to an online course. Please visit our 'Online Training Courses' webpage: https://www.candvs.com/courses-online.asp Alternatively, download the brochure and use the links within it to access the online webpage for the HVAC course.

COPENHAGEN 3-day course on the use of RABS and Isolator Technology in Aseptic Processing · This course covers the design, installation, qualification and operation of isolator systems and restricted access barrier systems (RABS), as used in aseptic manufacturing. It looks at the choices of systems available and the advantages and disadvantages of using Isolators and RABS over traditional Aseptic Manufacturing. The course also covers system design (types of systems, ergonomics, air classification and air-flow requirements) and the qualification / verification of the equipment systems involved, including facility and HVAC systems for isolators/RABS and surrounding/supporting areas. Also included in the course, is the development, optimisation and qualification of sporicidal decontamination cycles, together with requirements for operation, maintenance, testing, inspection and monitoring of the systems and environments involved. The impact of the new EU Vol.4 Annex 1 (Aug 2022) on the design, qualification and operation of RABS/isolator systems will be discussed, together with the latest developments in gloveless automated isolators. 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 12 Mar 2024), are included in the overall package.