Pharma Tips

Pharma Compliance & Validation Training / Education Courses

By: Pharma Tips | Views: 12307 | Date: 15-Jan-2013

Our wide range of residential pharmaceutical compliance and validation training / education courses are detailed below:Simple question, not always the easiest to answer. We can certainly help. Our pharmaceutical compliance and validation training / education courses and pharmaceutical consultancy services are all aimed at making this an easier question to answer. Please take the time to have a look at our services in more detail.

Compliance & Validation Training Service

Pharmaceutical Compliance & Validation Training Courses



Pharma Compliance & Validation Training / Education Courses



Compliance & Validation


Our wide range of residential pharmaceutical compliance and validation training / education courses are detailed below:
[NOTE: Course fees will be subject to a 20% UK VAT charge if your billing/invoice address is in the UK or delegates are UK based]

Simple question, not always the easiest to answer. We can certainly help. Our pharmaceutical compliance and validation training / education courses and pharmaceutical consultancy services are all aimed at making this an easier question to answer. Please take the time to have a look at our services in more detail.

IN House Training

We recognise that sending a delegate or a number of delegates on a residential pharmaceutical validation training course may not be the ideal solution for everyone.

You may have several delegates that require pharmaceutical equipment / process related training on the same subject and/or you may wish to optimise on delegate away time and cost. In this case a pharmaceutical validation training course run on or near to your site for delegates from your particular company may be what you are looking for.

Our in-house pharmaceutical validation training / education courses range from a slight variation on the equivalent residential training course to a compliance / validation course partially or fully customised to your specific requirements.

We believe that our use of a blend of “tried and tested” Industry experts and compliance professionals with recent “hands-on” experience, puts our pharmaceutical validation training courses amongst the best available.

Being environmentally conscious, we try to minimise the number of handouts by giving each participant a flash memory stick containing all the pharmaceutical training course related presentations and associated notes in printable PDF file format. We will also provide a condensed presentation printout binder to allow delegates to make notes if they wish.


Our in-house pharmaceutical compliance and validation education / training courses include:

  • Aseptic Processing
  • Cleaning Validation
  • Computerised System Qualification
  • Critical Utilities - Commissioning and Qualification
  • Introduction to Validation
  • Pharmaceutical HVAC Systems
  • Pharmaceutical Equipment Qualification
  • Pharmaceutical Process Validation
  • Sterilisation and Sterilisation Qualification
  • Validation of Storage Conditions

If you require more information about our in-house pharmaceutical compliance and validation training / education courses or wish to discuss your requirements and obtain a quote, please send an e-mail to info@candvs.com or call on +44(0)1625 500833


Residential Training

We run a range of carefully structured residential pharmaceutical compliance / validation training / education courses covering a wide range of key compliance subject areas. Topics are carefully chosen to target known areas of regulatory concern where there is a potential for learning opportunities. In this way we can bring the maximum benefit to delegates and companies in terms of compliance performance.

Our pharmaceutical validation training courses are attended by a multitude of pharmaceutical companies across Europe, Asia and Africa (see Testimonials) and we are very confident that it helps them to comply with pharmaceutical regulatory expectations and helps maximise the performance of their staff.

Our main goal is to provide enjoyable, informative and relevant courses that have a high degree of participation from the delegates.

By attending any one of our pharmaceutical compliance and validation training / education courses, delegates will have improved their technical and regulatory knowledge in the subject area and will be more familiar with current best industry practices. We hope that this will inspire them to tackle their normal job role with a new levels of impetus and confidence.

We believe that our use of a blend of “tried and tested” Industry experts and pharmaceutical compliance professionals with recent “hands-on” experience, puts our pharmaceutical training courses amongst the best available.

Being environmentally conscious, we try to minimise the number of handouts by giving each participant a flash memory stick containing all the presentations and associated notes in printable PDF file format. We will also provide a condensed presentation printout binder to allow delegates to make notes if they wish during the pharmaceutical training course.

All our pharmaceutical compliance and validation training / education courses are structured with the aim of maximising the learning experience and levels of enjoyment. This is achieved by ensuring that:

  • The pharmaceutical compliance and validation training course is properly structured in logical chronological order, with sufficient time throughout for discussion and debate.
  • Pharmaceutical training course presentations are clear and maximise the use of visual aids (photographs, videos and diagrams) where possible.
  • Speakers reinforce the messages using “real-life” examples.
  • Our pharmaceutical training course presentations are broken up with ample numbers of group activities that encourage involvement of all the attending delegates.
  • Complementary social events are arranged for the evenings of day 1 of the pharmaceutical training course (course dinner plus drinks) and on many occasions day 2 (various events, depending on the training course duration and venue).

Our Consultancy Service

Maintaining knowledge of all current regulations, guidelines and major issues is essential for delivering up-to-date compliance and validation courses.

This in combination with recent relevant consultancy/validation projects, puts us in an excellent position to provide advice and recommendations for compliance improvements, helping you achieve enhanced compliance performance.

For more information send an e-mail to info@candvs.com or call on +44(0)1625 500833

Our consultancy services include, but are not limited to:

  • Review of validation documentation packages to identify gaps and recommend corrective and preventative actions as part of an inspection readiness programme
  • Provision of compliance and validation advice at the early stage of projects
    • Helping develop qualification and validation strategies
    • Writing validation (master) plans
    • Providing advice and help with writing and implementing validation procedures
    • Carrying out GMP reviews of design (conceptual through to detailed design) - ensuring optimum levels of compliance are built in to the design
  • Reviewing routine operations in terms of GMP compliance, identifying gaps and proposing corrective and preventative action.
  • Helping implement effective quality systems.
  • Helping in the resolution of imposed regulatory actions related to compliance and validation.

Biopharmaceutical / Pharmaceutical Equipment System Cleaning and Cleaning Validation

Very good course, cleverly built up. · Delegate from Staelcon, Belgium

Very informative and relevant. What makes it more interesting is that the presenters have experience and up-to-date information and techniques. · Delegate from Biovac Institute, South Africa

It is a very good course and I will recommend it to others who work with Cleaning and Cleaning Validation. · Delegate from Novo Nordisk, Denmark

Cold Chain Management and Qualification of Pharmaceutical / Biopharmaceutical Storage and Distribution

Very informative and helpful. Relates to the workplace. · Delegate from Napp Pharmaceuticals

Very good course, good content, presenters very knowledgeable and useful workshops · Delegate from F Hoffman La Roche

The content / agenda fully covered the subjects discussed. I got all the answers to my questions. Above expectations. I will recommend to my colleagues. · Delegate from Kamada Ltd, Israel

Very good organisation and good topics · Delegate from Vodilo, Slovenia

Critical Utilities Course

This course was beyond expectations! · Delegate from Biovac Ltd, Israel

Very informative. Everything is just easy to take home and use. Would recommend it to others!! · Delegate from Bavarian Nordic

Very good, professional and detailed · Delegate from Stryker Orthopaedics, Ireland

A very good course with a good balance between design, construction, commissioning and qualification steps. I recently attended a three day course by another company and I found the technical detail of your course to be better, more was covered and the group exercises were far superior on your course · Delegate from GE Healthcare, Ireland

Pharmaceutical and Biopharmaceutical Facility HVAC Systems

Very good course. Fully fulfilled my needs · Delegate from Abbot Biologicals, Portugal

This course was very good. I am now much better prepared for discussions with the QA people, engineers and inspectors! · Delegate from Novo Nordisk, Denmark

All over good and interesting course · Delegate from Weifa AS, Norway

The Use of Restricted Access Barrier Systems (RABS) & Isolator Technology in Aseptic Manufacturing

Very useful course for me. Before coming I hadn't any knowledge on the subject and I have learnt a lot of things to conduct our project. · Delegate from Famar L'Aigle

Very informative course with the majority of the topics covered extremely relevant to my role. The drinks reception, dinner and boat trip were an excellent way of interacting the group. · Delegate from MSD Ireland

Very interesting, plesant atmosphere and good quality of course (both presenters and presentations). · Delegate from Baxter

Excellent content. Good pace. Examples were very informative. I'd recommend this course to others at Genzyme. Meal and boat trip were much appreciated. · Delegate from Genzyme

Validation of Computerised Control and Computerised Business Systems

Thanks to all speakers for delivering a high quality course in a very interesting, interactive and applicable manner. I would definitely recommend the course to others. · Delegate from Ranier Technology, UK

I came away with practical experience and step by step advice which can be applied at work (including examples of templates etc) · Delegate from Nestle, Switzerland

For me I now have a better understanding of the different aspects of validation and a guidance/framework for my work · Delegate from Cardialysis BV, Netherlands


Companies who have booked courses with us:

Abbot Biologicals BV - Netherlands
Abbott Healthcare Products BV Portugal
Abic Biological Laboratories Ltd - Israel
Actelion Pharmaceuticals - Switzerland
Algeta ASA - Norway
Allergan Pharmaceuticals Ltd - Ireland
Amo Abbot - Sweden
Axellia Pharmaceuticals ApS - Denmark
Bavarian Nordic A/S - Denmark
Baxter R + D Europe - Belgium
BD Medical - France
Becton Dickinson - Hungary
Bioniche Pharma - Ireland
Biovac Institute - South Africa
Biovac Ltd - Israel
Boehringer-Ingelheim Pharma - Germany
Bristol-Myers Squibb Intl - Belgium
CAPSUGEL - France
Cardialysis BV - Netherlands
Celgene International - Switzerland
Chaswill Process Technology - South Africa
CMC Biologics - Denmark
Covidien Pharmaceuticals - Ireland
Dr Reddys - India
Eden Biodesign - UK
Eli Lilly - Ireland
Fine Organics - UK
Fisher Clinical Services - UK
Fresenius Kabi - Sweden
GE Healthcare - Ireland
GE Healthcare - Norway
Gideon Richter Ltd - Hungary
Genzyme - UK
Glaxo SmithKline - Belgium
Glaxo SmithKline - Spain
IBM - Belgium
Intervet International BV - The Netherlands
Ipsen Biopharm - UK
Isotope Laboratories - Norway
Janssen Pharmaceutical - Belgium
Kamada Ltd - Israel
Kedrion Biopharmaceuticals - Italy
LEK S.A - Poland
Lonza AG - Switzerland
Merck Sharp and Dohme - The Netherlands
Nestle PTC Konolfingen - Switzerland
NNE Pharmaplan - Denmark
Norwegian Institute of Public Health - Norway
Novartis Pharma - Switzerland
Novo Nordisk - Denmark
Nycomed - Norway
Omrix - Israel
Pfizer - Ireland
Pfizer - Belgium
Pliva Krakow - Poland
PRA International - The Netherlands
Ranier Technology - UK
Roche - Italy
S.P.A.M.I.srl - Italy
Sandoz - Turkey
Sanovel - Turkey
Sanquin Bloed Voorzuoning - Holland
SNC Lavalin - Belgium
Solvay Pharmaceuticals - The Netherlands
Sopharma - Bulgaria
SSI - Denmark
Staelcon - Belgium
Stryker Orthopaedics - Ireland
Swedish Orphan Biovitrum - Sweden
Syral Iberia - Spain
Taro Pharmaceuticals - Israel
UCB Pharma SA - Belgium
Vink Industries - The Netherlands
Vleugel Engineering - The Netherlands
Vodilo - Slovenia
Weifa AS - Norway
Xendo Pharma Services B.V. - The Netherlands

March 2013

Course TitleStartEndPrice
RABS & Isolator Technology
The use of Restricted Barrier Systems (RABS) and Isolator Technology in Aseptic Processing.


19th March 201321st March 2013£1,395

April 2013

Course TitleStartEndPrice
Equipment System Verification / Qualification and Process Validation
Combined course: 2-Day Equipment System Verification / Qualification + 2-Day Process Validation


16th April 201319th April 2013£1,745
Equipment System Verification / Qualification
A Risk Based approach to Pharmaceutical Equipment System Verification / Qualification


16th April 201317th April 2013£1,045
Pharmaceutical Process Validation
Validation of Pharmaceutical and Biopharmaceutical Manufacturing Processes


18th April 201319th April 2013£1,045

May 2013

Course TitleStartEndPrice
Cleaning & Cleaning Validation
Pharmaceutical equipment design (for cleaning), calculating limits, cleaning process validation


14th May 201316th May 2013£1,395

June 2013

Course TitleStartEndPrice
Computer System Validation
Validation of computerised data management (business) and control systems - A practical approach


4th June 20136th June 2013£1,395

September 2013

Course TitleStartEndPrice
Understanding Pharmaceutical Sterilisation
Sterilisation Processes and Equipment Operation, Maintenance/Calibration and Validation.


17th September 201319th September 2013£1,395

October 2013

Course TitleStartEndPrice
RABS & Isolator Technology
The use of Restricted Barrier Systems (RABS) and Isolator Technology in Aseptic Processing.


8th October 201310th October 2013£1,395
Pharmaceutical Critical Utility Systems
Design, commissioning and qualification/verification of pharmaceutical critical utility systems


15th October 201317th October 2013£1,395

November 2013

Course TitleStartEndPrice
Pharmaceutical HVAC Systems
Pharmaceutical HVAC system design, operation, energy saving, maintenance and qualification


5th November 20137th November 2013£1,395
Cleaning & Cleaning Validation
Pharmaceutical equipment design (for cleaning), calculating limits, cleaning process validation


19th November 201321st November 2013£1,395

December 2013

Course TitleStartEndPrice
Pharmaceutical Cold Chain & Storage Conditions Qualification
Cold Chain Management, Design/Construction/ Qualification of Storage Facilities/Distribution Systems


3rd December 20135th December 2013£1,395

Recent Courses

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

Cleaning and Cleaning Validation
Pharmaceutical equipment design (for cleaning), calculating limits, cleaning process validation · This pharmaceutical training course covers key design features of pharmaceutical and biopharmaceutical manufacturing equipment/systems to enable effective, ‘easy’ cleaning and provides a detailed understanding of the approach to validating cleaning processes. This includes understanding the material carryover (contamination) mechanisms involved, which are pivotal to setting meaningful limits for maximum allowable carryover [MAC] limits. The course also covers applicable regulatory rules & guidelines; demonstration of spray device coverage; methods for calculating MAC (wide range of residue types); methods for sampling/detecting/quantifying residues; clean/dirty hold times; matrix approach to multi-product non-dedicated equipment; cleaning process monitoring/review and maintaining the validated state.
Computer System Validation
Validation of computerised data management (business) and control systems - A practical approach · Unlike many computer validation courses, this pharmaceutical training course concentrates on what actually works in real life with respect to the quality management, operation and qualification of computerised data management (business) systems and equipment control systems. This will be supported by the high level of relevant and recent practical knowledge of the presenters involved.The first part of the course covers the general theory and terminology relating to the validation phases and will encompass current applicable regulatory rules/guidance and international standards/guidelines (including GAMP 5). It will also cover the operational and quality management activities relating to: routine operation/management; system/process/validation review; data management and system retirement. A full set of example procedures and templates will be provided for the areas covered under this section of the course.The second and major part of the course will be dedicated to working through, in a very practical way, qualification activities/testing relating to key areas of computerised systems such as: infrastructure qualification/verification; packaged system qualification/verification; IS Systems (data management systems); and plant /equipment control systems. This will be heavily supported by example test sheets and real-life examples.
Equipment System Verification / Qualification
A Risk Based approach to Pharmaceutical Equipment System Verification / Qualification · 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 E2500-07. 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.
Equipment System Verification / Qualification and Process Validation
Combined course: 2-Day Equipment System Verification / Qualification + 2-Day Process Validation · This pharmaceutical training course is a combination of both the 2-day Equipment System Verification/Qualification course and the 2-day Process Validation Training Courses.It is aimed at delegates who want to extend their knowledge of both equipment systems qualification and process validation.Delegates also have the option of booking on either of the 2-day courses.Please see overviews for each of the 2-day courses for more details.
Pharmaceutical Cold Chain & Storage Conditions Qualification
Cold Chain Management, Design/Construction/ Qualification of Storage Facilities/Distribution Systems · This pharmaceutical training course not only covers the fundamental considerations, challenges and solutions for effective cold chain management, it goes that one stage further and gives delegates an in-depth appreciation of the key design/construction considerations and attributes of storage facilities and distribution systems, together with practical strategies and techniques for validating the systems involved. Included within the scope of this course are areas such as: key regulatory rules and guidance; key guidance and instructions from international organisations; design and qualification of storage systems from ‘bench’ type through to large storage facilities; cold box qualification for range of climatic conditions (rationalising qualification strategy); vehicle design and qualification; monitoring systems (including qualification); risk management and key qualification document considerations.
Pharmaceutical Critical Utility Systems
Design, commissioning and qualification/verification of pharmaceutical critical utility systems · The 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, highly purified water, 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. 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.
Pharmaceutical HVAC Systems
Pharmaceutical HVAC system design, operation, energy saving, maintenance and qualification · This pharmaceutical training course provides delegates with an in-depth understanding of the key aspects of Heating Ventilation & Air Conditioning (HVAC) System design (designed in tandem with the facility), construction, operation and maintenance. It covers facility HVAC systems for a range of drug product types and APIs, including non-sterile drug products, for example oral solid dose/oral liquids, inhalation non-sterile products and aseptically manufactured products. Key considerations such as dust removal, ATmosphere EXplosibles (ATEX) compliance are also covered by this course. To ensure this course is properly rounded, areas such as a risk based approach to the qualification of HVAC system equipment and the validation / qualification of environmental conditions, for sterile and non-sterile facilities, are carefully integrated into the course.The course also recognises the current drive towards energy savings / carbon emission reduction and includes useful information on how the energy usage of Pharmaceutical HVAC Systems can be correctly assessed and subsequently reduced by changing the operating philosophy (based on risk assessments) and making suitable modifications. This will be reinforced with the use of real-life examples.
Pharmaceutical Process Validation
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 maintaining the validated state, including revalidation are also covered by this course.
RABS & Isolator Technology
The use of Restricted Barrier Systems (RABS) and Isolator Technology in Aseptic Processing. · This pharmaceutical training course covers the A-Z of Isolator Technology and Restricted Access Barrier Systems (RABS) used in Aseptic Manufacturing.The course also covers barrier system design and selection, covering areas such as: the risk of product contamination and the subsequent risk to patient; the types of systems available; ergonomics; types of sanitisation systems, e.g. vapour phase hydrogen peroxide (VPHP); air-handing system requirements, pressure regimes, device/surrounding area classification; monitoring systems; and the overall advantages and disadvantages of using Isolators or RABS over traditional Aseptic Manufacturing (advanced aseptic processing versus standard Grade A to B interfaces). It also provides an overview of all key applicable guidelines, standards and regulations, and will cover the origins (myths, legends and science) behind the standards currently used.A detailed approach to the optimisation and qualification of sanitisation cycles will be included, together with requirements for operation, maintenance, testing, inspection and monitoring of the systems and environments involved. The course is heavily orientated towards basing decisions for design, qualification/verification, operation and routine monitoring/testing/inspection on risk to product quality and ultimately risk to patient.
RABS & Isolator Technology
The Use of Restricted Barrier Systems (RABS) and Isolator Technology in Aseptic Processing. · This pharmaceutical training course covers the A-Z of Isolator Technology and Restricted Access Barrier Systems (RABS) used in Aseptic Manufacturing.The course also covers barrier system design and selection, covering areas such as: the risk of product contamination and the subsequent risk to patient; the types of systems available; ergonomics; types of sanitisation systems, e.g. vapour phase hydrogen peroxide (VPHP); air-handing system requirements, pressure regimes, device/surrounding area classification; monitoring systems; and the overall advantages and disadvantages of using Isolators or RABS over traditional Aseptic Manufacturing (advanced aseptic processing versus standard Grade A to B interfaces). It also provides an overview of all key applicable guidelines, standards and regulations, and will cover the origins (myths, legends and science) behind the standards currently used.A detailed approach to the optimisation and qualification of sanitisation cycles will be included, together with requirements for operation, maintenance, testing, inspection and monitoring of the systems and environments involved. The course is heavily orientated towards basing decisions for design, qualification/verification, operation and routine monitoring/testing/inspection on risk to product quality and ultimately risk to patient.
Understanding Pharmaceutical Sterilisation
Sterilisation Processes and Equipment Operation, Maintenance/Calibration and Validation. · This course provides delegates 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 separator out 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 delegates 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.

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