GMP COURSE Course No 16741 Computer Systems Validation Master Class & Leveraging Suppliers - Save up to EUR 490 by booking both courses 21-24 May 2019, Vienna, Austria Costs: Non-ECA Members: EUR 2.390,-- ECA Members: EUR 2.190,-- EU GMP Inspectorates: EUR 1.440,-- APIC Members (does not include ECA membership): EUR 2.290,-- (All prices excl. VAT) If you have any questions, please contact us: Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@concept-heidelberg.de BOOK COURSE ECA Members Non-ECA Members EU GMP Inspectorates APIC Members (does not include ECA membership) REGISTER FOR CONFERENCE EXHIBITION OUR SERVICE » Seminar Program as PDF » Testimonials » Mobility Partnership » Save date in Outlook

Speakers Frank Behnisch, CSL Behring, Germany Maik Guttzeit, GEA Lyophil, Germany Yves Samson, Kereon AG, Basel, Switzerland Dr Rob Stephenson, Rob Stephenson Consultancy, UK Programme Computer Validation: Leveraging Suppliers Introduction – What the Participants Expect An open session capturing the expectations of the delegates Leveraging Suppliers Expertise: An Overview of Good Practice What is current Good Practice? Optimising Supplier involvement Integrating the Supplier’s expertise and deliverables into your validation process How to do more with less Performing a Supplier Assessment Why Assess the Supplier? The Overall Process Assessment Topics Types of Assessment Corrective Actions & Follow Up Audits Identifying Leveraging Opportunities 1: Quality Planning Quality Planning Assuring Quality Quality Controls Identifying Leveraging Opportunities 2: Leveraging Testing Activities What must the supplier do What must the regulated company do Which supplier tests can be accepted Managing Quality within an Outsourced IS/IT Environment Making a Business Case Outsourced Supplier Specification and Selection Implementation Monitoring Contract Change and Exit Computer Systems Validation Master Class Introduction – Gain Understanding of Delegate Experience and Background Roles, Responsibilities and Governance Activities for Effective Governance Process and System Ownership The role of Subject Matter Experts The role of QA Writing Requirements Documents What goes into a requirements document? What are the considerations for systems? Characteristics of good and bad requirements documents Sources of requirements information Practical Use of Scalability What do we mean by Scalability? How does it work in practice? How can we combine documents successfully? How much is enough? More about Risk Management What is really important in managing risk? How do you set the “threshold of acceptable risk”? The importance of Risk Registers How to document risk management for benefit Design Review – A Critical Process When to perform a Design Review? Who should participate? How to document the Review How to manage the findings Upcoming Challenges in IT Open source software / Agil Global systems EBR / MES Cloud Computing / Virtualisation Infrastructure Qualification / ITIL Interactive Session: Good Validation Practices Open session in which delegates score their CSV system themselves against 12 good validation practices Each good practice introduced Delegates score themselves Results consolidated and fed back Allows delegates to compare their CSV system against best practice and other Practitioners Change Control and Configuration Management Responsibilities Planned/unplanned changes Classification Interactive Session: Change Control Examples Delegates will work on a variety of change management scenarios Evaluating the magnitude and impact of the change Application of the principles of risk management Leveraging supplier and SME (Subject Matter Expert) expertise Minimising the workload whilst maintaining compliance Validating Spreadsheets Why are spreadsheets high risks? Design considerations What is important (risk again)! How to document spreadsheet validation Risk Management and Electronic Records A clear definition of electronic records with examples An overview of the principles of risk management applied to the classification of electronic records When is an audit trail needed Do we need to keep chromatographic (and other) raw data? Examples of the application of controls Impact of the approach on validation of e-record systems Code Review Principles of code review Regulatory expectations of code review Carrying out code reviews Recording and documenting code reviews Data Integrity – Formulating a Company Strategy Management accountability Incorporation of data governance in the Quality Management System Defining appropriate metrics Auditing the data integrity processes Reviewing progress Handover – the Process and Package What is the handover process? Who is the system owner? What does the system owner have responsibility for? How can we persuade the system owners to accept responsibility? Workshop 1: What the Delegates expect Working in groups delegates derive their requirements from the training event and share them with the tutors Capturing delegates expectations Sharing and reducing to key points in groups Sharing with all delegates and tutors Workshop 2: Implications for your Organisation How does the GAMP® 5 approach change the way we carry out and control our validation/verification activities? Who will be impacted by the changes? What is the role of IT Engineering Subject matter experts QA Workshop 3: Writing a Requirement Specification A short exercise to create a working URS and a review of the output Delegates will work on a simple requirements scenario Output will be discussed with the tutors The feedback will be combines and fed back to the delegates Lessons learned will be summarised Workshop 4: Scalability of Validation Delegates will be asked to work out what is work a scaled approach to a multi-component system to minimise the cost and time required for validation How should the system be subdivided? How can risk management be applied? What sub-projects are appropriate? Who is involved in each?? What will the validation plan look like? Workshop 5: Application of GAMP® Risk Management Methodology to a Computer System Delegates will work on a different case study using risk management to reduce the validation effort. Assessment of risks Formulation of an approach Impact on the validation effort Feedback on the outcome of the case study Workshop 6: Design Review The delegates will be presented with the typical findings from a Design Review and, in a team-based exercise, will develop a set of risk-based corrective actions to address the issues. Workshop 7: Data Integrity The delegates will be presented with an audit observation about deficiencies in the management of data. They will be asked to device a programme to improve data integrity governance as part of the response to the regulatory observation. Case Study – GAMP® 5 approach A case study will be presented to illustrate how, using the principles in GAMP® 5, the cost of validation was more than halved. The simplification of the validation system The leverage of supplier expertise The use of the risk-based approach The financial and other benefits of the GAMP® 5 approach