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 / critical design elements of manufacturing systems. A pivotal theme of the course is a risk-based approach to qualification of manufacturing equipment systems, as defined under the ISPE baseline guides and ASTM E2500. As a result, System Classification, System Risk Assessments and the process of identifying critical aspects/critical design elements of manufacturing systems are covered in detail. Underpinning all of this is the understanding of the processes involved and having clear definitions of Critical Quality Attributes, Critical Material Attributes, Critical Process Parameters and control ranges/philosophy, which will be covered in the introductory presentations. 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 1 Oct 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 covering the 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 bio-pharmaceutical process validation. The course covers process validation for pharmaceutical and bio-pharmaceutical 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 packing operations (covers different types of primary packaging) is included, together with an overview of key regulations, guidelines and standards, including the 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. 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 15 Oct 2024), are included in the overall package.

COPENHAGEN 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. 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 17 Sep 2024), are included in the overall package.

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.

COPENHAGEN Design, Qualification and Operation of Temperature Controlled Storage & Transportation Systems · This pharmaceutical training course covers typical life-cycle approaches to the design, qualification and operation of temperature controlled storage and transportation systems, facilities and equipment. Systems, facilities and equipment have been placed into logical groups and attendees will be taken through their respective life-cycle (design, qualification/validation and operation). The course aims to cover the common and latest systems involved in the storage and transportation of drug products. It includes detailed information concerning how to map internal conditions across the spectrum of storage and transportation conditions used in the pharmaceutical industry. Also covered, are the wide range of instrumentation available for monitoring and mapping and how the placement of monitoring probes can be linked to/integrated into the mapping exercises undertaken as part of the validation life-cycle. The potential adjustment of upper and lower limits for storage conditions, to allow for instrument uncertainty, will be covered as part of the instrumentation presentation. The course will also focus on operational considerations for each system/facility/equipment group, covering subjects such as ongoing risk management, continuous improvement, data reporting/management and dealing with non-conformance, e.g. temperature excursions. There will be multiple interactive exercises to break up the presentation material and reinforce learning throughout the course. 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 19 Nov 2024), are included in the overall package.

COPENHAGEN Design, Qualification and Operation of Temperature Controlled Storage & Transportation Systems · This pharmaceutical training course covers typical life-cycle approaches to the design, qualification and operation of temperature controlled storage and transportation systems, facilities and equipment. Systems, facilities and equipment have been placed into logical groups and attendees will be taken through their respective life-cycle (design, qualification/validation and operation). The course aims to cover the common and latest systems involved in the storage and transportation of drug products. It includes detailed information concerning how to map internal conditions across the spectrum of storage and transportation conditions used in the pharmaceutical industry. Also covered, are the wide range of instrumentation available for monitoring and mapping and how the placement of monitoring probes can be linked to/integrated into the mapping exercises undertaken as part of the validation life-cycle. The potential adjustment of upper and lower limits for storage conditions, to allow for instrument uncertainty, will be covered as part of the instrumentation presentation. The course will also focus on operational considerations for each system/facility/equipment group, covering subjects such as ongoing risk management, continuous improvement, data reporting/management and dealing with non-conformance, e.g. temperature excursions. There will be multiple interactive exercises to break up the presentation material and reinforce learning throughout the course. 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 11 Jun 2024), are included in the overall package.