Compliance & Validation Services
Presents a 3-Day Training Course on:
Qualification of Manufacturing Systems
10, 11 & 12 May 2011
Radisson Blu Hotel, Amsterdam
Planning, Approach and Early Project Life-cycle Activities:
• Regulations, guidelines and current industry trends
• Basing testing requirements on risk to GMP & Product Quality
(incorporating ISPE, ASTM E2500-07 and Quality Risk Assessment
• Organisation and planning for validation (often overlooked)
• Preparing effective verification /validation documentation
• Design Review (Design Qualification)
• Good Automated Manufacturing Practice (GAMP) overview
• GMP compliance during equipment system construction
• Factory Acceptance Testing and Site Acceptance Testing
• Mechanical completion, pre-commissioning and commissioning
• Using FAT/SAT/commissioning testing documents for
Equipment System Verification/Qualification Activities:
• Verifying the installation (Installation Verification)
• Functional testing (Operational Verification/Qualification)
• Verifying system performance (Performance
• Process validation (Risk Based)
• Maintaining the validated state (key supporting systems)
Qualification of Manufacturing Systems & Pharmaceutical/Biopharmaceutical Process Validation - Course Summary
This course provides delegates with an in-depth appreciation of all project life-cycle activities, ranging from early project planning/design through to the
verification/qualification of critical aspects of manufacturing systems /equipment and the final process validation stages. The course also provides up-to-date information on
current applicable regulatory and international standards and guidelines, together with a current industry approach to verification/qualification and validation. Key areas of
focus for the course include: linking equipment design/functionality to the process; ensuring the level and depth of equipment system testing is based on risk to product
quality, patient safety and system complexity/novelty; and process validation is performed on a well developed, documented and robust process.
The course will be presented by industry experts who, collectively, have worked within the vast majority of areas relating to equipment/manufacturing system
commissioning/qualification and process validation. Their considerable and recent hands-on experience/knowledge base will provide up-to-date learning on current industry
best practice, using practical real-life examples. There will be opportunities to put the learning into practice during carefully chosen interactive group exercises/case studies.
Day-time meals and refreshments together with a drinks reception and course dinner, held on the evening of Day 1, are included in the overall package.
Mike James, Director, Compliance & Validation Services Limited.: Mike has over John Welbourn, Director, Compliance & Validation Services Limited: A validation
17 years experience in the pharmaceutical industry, working in a variety of compliance professional with over 18 years experience, John has been responsible for the management
and validation roles. His experience includes preparation and delivery of national/client- and execution of validation projects for many major pharmaceutical companies. He has
based validation training courses, hands-on validation work, validation project broad experience in the qualification of equipment, utilities and computerised systems, and
management and regulatory compliance consultancy. Previously, Mike spent four years thermal mapping to support storage conditions. He has presented at conferences in the UK,
as the Site Validation Manager for GlaxoSmithKline (GSK) at Speke, where he was Europe and the US and has authored several articles on various aspects of validation. John
responsible for all site validation activities, including the development and maintenance has contributed to The University of Manchester’s, Pharmaceutical Engineering Advanced
of the Site Validation Programme. Before moving to the pharmaceutical industry he Training (PEAT) Course and Dublin Institute of Technology’s (DIT) MSc. course in
spent 15 years as an industry chemist. Pharmaceutical Process Validation.
Brian Collins, Global Operations Manager, GE Healthcare Life Sciences: Brian is Peter Whyment, Senior Scientist, Lilly UK: Peter has worked within Lilly, at the
responsible for supporting the Global Scientific Asset Services (SAS) team by building Speke Operations manufacturing facility in the United Kingdom for over 30 years.
robust operational infrastructure, and enforcing adherence to processes to ensure and During this time he has gained valuable experience within Quality Control Laboratories,
improve Global Operational excellence in this business unit. He is also accountable for Analytical Development and as a senior scientist in the Manufacturing, Science &
the oversight of the implementation of new SAS programs into customer sites. Brian has Technology (MS & T) department. As a key team member, Peter has overseen the
held senior management positions covering a variety of quality and validation roles successful technical transfer or commercial manufacturing of several biotechnology
including responsibility for providing technical support to develop best practice, novel processes, including Insulin and growth hormone products. Peter has recently received
solutions and harmonized processes in cold chain and validation whilst working for Eli Lilly’s "Polaris" award, the highest award granted to an individual in the MS & T
Wyeth. Brian was also responsible for managing validation activities at Wyeth’s UK organisation, recognising his outstanding technical contribution to Lilly.
manufacturing site. He has developed extensive cross-functional experience through a
number of quality, pharmaceutical technology and operations management roles
Who Should Attend
Individuals to benefit from attending this course include anyone involved directly or indirectly in equipment system verification/qualification and process validation activities.
The course is ideally suited to people who are new to validation roles or people whose job roles require them to have a general understanding of validation activities
throughout a project life-cycle. This will involve personnel from production, quality assurance, validation, technical support and engineering departments.
On leaving the course delegates will: have a broad and detailed understanding of the activities involved in the commissioning/verification/qualification of equipment systems
and process validation; be able to apply and share their new knowledge; improve their individual effectiveness; and look back on an enjoyable experience.
Radisson Blu Hotel, Amsterdam: Ideally situated in the historical heart of Amsterdam, close to the main tourist attractions, museums, theatres, shopping areas, red-light and business districts.
The hotel has a fitness centre and excellent conference and banqueting facilities.
Address: Rusland 17, NL-1012 CK Amsterdam, Netherlands Click on image to visit
Tel: +31 20 623 1231 the hotel’s website
Fax: +31 20 520 8200
Reservations (email): email@example.com
Delegates are kindly requested to arrange their own accommodation. Course fees are £1,295.00 (GBP) per delegate. Accommodation is NOT included in the course fees.
Qualification of Manufacturing Systems & Pharmaceutical/Biopharmaceutical Process Validation - Course Programme:
Registration (08:30 to 09:00) – Delegates arrive at the meeting room and sign the attendance register. Each day will include at least one detailed interactive group exercise.
DAY 1 (10-May-2011) Day 2 (11-May-2011) Day 3 (12-May-2011)
09:00 Opening/Welcome [Mike James] Day 2 Introduction (09:00) Day 3 Introduction (09:00)
General Introduction [Mike James]: Title Factory Acceptance Testing (FAT) [Mike James]: Performance Qualification [John Welbourn]:
Course structure and content explained Why is acceptance testing performed at the vendor’s site? System hand-over
Brief overview of current applicable guidelines and regulations What are the differences between FAT and Site Acceptance testing What is its purpose/scope and how does it differ from process
Icebreaker exercise (SAT)? validation
Key components of FAT and working effectively with vendors Typical Approach
Documentation requirements and integrating FAT with Qualification Sampling and sampling plans (Utilities/Process system AQL’s )
activities (use of vendor’s documentation) Overview of testing carried out (using example systems)
Execution and close-out Documentation involved and protocol requirements
Risk-Based Approach to Equipment System Verification/ GMP Compliance During Construction & Construction Verification Process Validation [Mike James]:
Qualification [Mike James]: [John Welbourn]: Process development and how this critical activity fits in to
Purpose and timings Control of materials, fabrication processes and work practices validation
Defining systems and their boundaries Consequences of poor practice Defining the product and process
Importance of understanding the process Construction testing/checking (welding QC, line slope, deadleg) Concept of Operating, Design and Characterisation Spaces
System Impact Assessments and Component Criticality (includes Materials of construction verification (traceable) Quality by design/design of experiments
worked examples) Process robustness and process capability
Documentation (procedures and reports) Regulatory expectation (includes draft FDA Guide)
Equipment system verification in accordance with ASTM E2500-07 and Process validation data and regulatory submission requirements
its impact on what we do now Does the 3 consecutive batch model still apply?
Organisation for Validation [Brian Collins]: Mechanical Completion, Pre-commissioning and Commissioning Sampling (Acceptable Quality Levels)
Chronology of events [John Welbourn]: Documentation requirements
Different ways validation documentation can be structured (modular Construction/mechanical completion process Drug product filling example
and non-modular approaches) Stages/activities associated with pre-commissioning Small molecule API example approach
Validation project planning Commissioning activities and examples of the type and level of testing Process Analytical Technology and how this can be used in
Key resource considerations carried out Process Validation
Engineering documentation / systems and procedures Vendor Package Site Acceptance Testing (SAT) On-going requirements
Integration with qualification (Leveraging)
Quality Risk Assessments (QRA) [Mike James]: Installation Verification/Qualification of Equipment System [Mike Process Validation - Biopharmaceutical API Manufacturing
Purpose, scope and timing James]: [Peter Whyment]:
Risk assessment process and associated documentation Overview of testing/checking carried out Real-life case study
How risk scores for risk scenarios can be linked to the level and depth General documentation requirements (includes example testing Process definition
of testing documents) Critical process control parameters
Reports (includes worked examples) Leveraging of information from FATs & SATs Sequence of events involved in a complex project
How QRA’s can be used to support validation/verification plans and for Supporting documentation and procedures Process validation testing strategy
a key rationale for the validation approach Discrepancy management Resolving issues
Preparing Protocols, Reports and Validation/Verification Plans Functional Testing of Equipment Systems (Operational Maintaining the Validated State [Mike James]:
[Brian Collins]: Verification/Qualification) [John Welbourn]: Change Management (Change Control)
Procedures (numbering, document control, data management and Overview of testing carried out Importance of good failure investigation processes
documentation standards) Testing based on risks to patient safety, GMP and equipment system On-going risk management and how this integrates with
Effective discrepancy/deviation management complexity validation + other supporting systems (e.g. calibration)
Validation (Master) Plans, summary reports and protocols / reports Leveraging of commissioning documentation Periodic Validation Review
(typical content, format, watch-outs and standards) Documentation requirements (includes examples of testing When is revalidation required?
documentation) Other important supporting systems
Design Review/Qualification [Mike James]: Good Automated Manufacturing Practice (GAMP) [Mike James]: Course Closure [All]:
Importance of Design Review (why carry it out) GAMP 5 approach to the validation/qualification/verification of Questions and answers
Vendor assessments and audits computerised/automated systems Course evaluation
GMP review of design Integration of automated systems and equipment system qualification Certificates
Links to impact assessment and Quality Risk Assessments (avoiding duplication of effort) and documentation requirements
Compilation of key documentation into a design dossier
Finish: 17:00; Drinks Reception & Course Dinner (Early Evening) Finish: 17:00 Finish: 16:00
BOOKING DETAILS: Qualification of Manufacturing Systems & Pharmaceutical/Biopharmaceutical Process Validation
10, 11, 12 May 2011 – Radisson Blu Hotel, Amsterdam
How to book on this course:
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Validation Services Limited, 8 Sedgefield Close, Macclesfield, Cheshire, SK10 2WF, United Kingdom.