Transcription
SAP – Validation andGMP Compliance Live demonstration: Using SAP SolutionManager as a Validation platform Get a set of useful templates for download SAP S/4 HANASPEAKERS:Thomas BrandacherPWC ConsultingLasse JanzDrägerFlorian RauchDHC Dr. Herterich andConsultants6-7 November 2018, Berlin, GermanyStefan StaubDHC Dr. Herterich andConsultantsStefan TempsDHC Dr. Herterich andConsultantsLEARNING OBJECTIVES: Validation–– Validation strategies–– What needs to be validated?–– Process oriented vs. transaction oriented–– Global versus local–– Best practice approach–– Agile vs. V-Model Operation–– Change management–– Lifecycle management–– Periodic evaluation–– Data Migration Audit trail in SAP Data Integrity and SAP SAP S/4 HANA in a GxP environmentThis education course is recognised for the ECA GMP Certification Programme „Certified Computer Validation Manager“.Please find details at www.gmp-certification.eu
SAP – Validation and GMP Compliance6-7 November 2018, Berlin, GermanyObjectivesProgrammeYou will learn How to validate SAP in a GMP environment Which specific requirements should be taken intoconsideration in the CSV process How to use SAP Solution Manager as a validationplatform What problems could arise during validation and howto solve them How to maintain the validated state of SAP with theleast effortsIntroduction SAP Validation Legal requirements Process oriented vs. transaction oriented validation Best practice approach Agile vs. V-ModelSAP Configuration Management vs. ValidationApproach Implementation Approach Customizing and Developments Change and Transport System Enhancement Packages and Business FunctionsBackgroundThe leading Enterprise Resource Planning (ERP) System inindustry is SAP. Meanwhile it has also become the standard solution for pharmaceutical companies.As the system is used for GMP critical operations (e.g.inventory, master data management, batch release) validation is a must and a critical element of the SAP implementation.Controlled operations, including Change Control willensure the validated state is maintained.This ECA course will offer you shared best practices forthe validation of SAP considering recent regulatoryrequirements like EU GMP Guide Annex 11, GAMP 5 and21 CFR Part 11.Target GroupThis Education Course is directed at experiencedemployees from IT & IT Service Providers Quality Assurance / Quality Control Production / Engineeringwho have to deal with SAP in a healthcare environment.TemplatesAll participants get a set of useful templates fordownload Validation plan User requirement specifications Functional specifications Test scripts Risk assessment questions SOPs for operating the validated system Data migrationSystem landscape of SAP Pharma process landscape What is needed and what needs to be validated(high level risk assessment) Introducing the SAP modules Standard risk assessment for each moduleLive demoUsing SAP Solution Manager as a Validation platform Project Tool in a regulated environment–– Document management–– Test management–– Document status report Support Tool–– Incident management–– Integrative change managementSpecial features of SAP HANA SAP S/4 Hana innovation highlights Transformation scenarios to SAP S/4 HANA Challenges for the validation approach Validation of S/4 HANA as cloud deploymentProcess harmonisation and standardisation usinga template strategy / SAP and GMP Compliance Functional gaps Process driven system functionality Compliance driven system functionalityManaging a global SAP program in a validatedenvironment Governance and global framework Vendor selection & staffing (including offshoring) Ramp up and training Documentation approach Milestones & key deliverables Toll gate reviews Data migration approach SOX in a project Handover to support Including templates and selected guidelines.
Data Migration A strategic approach to data migration Regulatory requirements and data migration Validating the data migrationData Integrity and SAP Regulatory requirements (FDA, EU, MHRA) Critical processes (QC) Roles and responsibilities SAP support tools (MDG)Audit trail in SAP Compliance for audit trails: definitions andrequirements A risk-based approach to audit trails Implementing audit trails Audit trail reviewsProcesses and experiences with validation of SAPwithin a regulatory context Change management; IT Validation and electronicrecord keeping for quality relevant process softwareas a manufacturer of medical devices How to ensure that quality relevant impacts areevaluated when changing a validated SAP system? How to ensure that efforts for validation are kept onan efficient level without compromising quality andregulatory requirements? How to effectively link system, process and validationdocumentation? How to manage electronic records within SAP?GMP compliance for SAP authorisation User and authorisation management Documentation approach for authorisation Testing of authorisation requirementsSocial EventIn the evening of the first course day, you are cordiallyinvited to a social event. This is an excellent opportunityto share your experiences with colleagues from othercompanies in a relaxed atmosphere.SpeakersThomas BrandacherPWC Consulting LLC, Tokyo, JapanThomas Brandacher was Head Global ERPProject Management Office (PMO) at theSandoz site in Holzkirchen close to Munich.Within Sandoz and other companies he managed SAPprojects over a period of more than 10 years. He joinedPWC Consulting as Managing Director in 2016.Lasse JanzDrägerwerk AG & Co. KGaA, GermanyLasse Janz studied Business Informatics at KielUniversity of Applied Science. Since 2015 heis a Quality Manager at Drägerwerk AG & Co.KGaA (Software Validation Officer, Global ProcessOwner Software Validation and Global Process OwnerElectronic Signature).Florian RauchDHC Dr. Herterich & Consultants GmbH,GermanyFlorian Rauch joined DHC Dr. Herterich &Consultants as a Consultant in 2013. Duringthe last years he worked in multiple SAP Solution Manager implementation and SAP authorization projects inmedical devices industry. Florian studied ComputerScience at the University of Applied Sciences in Schmalkalden (Germany).Stefan StaubDHC Dr. Herterich & Consultants AG,SwitzerlandStefan Staub joined DHC Dr. Herterich &Consultants AG as a Consultant in 2006. He isa specialist in Computerized System Validation with astrong focus on large SAP ERP implementation projects.Since 2012 he is part of the DHC AG management team.Prior joining DHC AG Stefan studied Business Administration with an emphasis on Information and TechnologyManagement at the University of St. Gallen (Switzerland).Stefan TempsDHC Dr. Herterich & Consultants AG,SwitzerlandStefan Temps joined DHC Dr. Herterich &Consultants as a Senior Consultant in 1996.Since 2000 he is Managing Director of DHC AG, Switzerland. During the last years he was engaged as projectmanager for SAP ERP implementation projects and GxPcompliance in the pharmaceutical industry. Prior tojoining DHC in 1996, Stefan studied Industrial Engineering and Management at the Technical University ofHamburg (Germany).
* Msyou have to inform us in writing. The cancellation fee will then becalculated according to the point of time at which we receive yourmessage. In case you do not appear at the event without havinginformed us, you will have to pay the full registration fee, even ifyou have not made the payment yet. Only after we have receivedyour payment, you are entitled to participate in the conference(receipt of payment will not be confirmed)! (As of January 2012)German law shall apply. Court of jurisdiction is Heidelberg.Privacy Policy: By registering for this event, I accept the processingof my Personal Data. Concept Heidelberg will use my data for theprocessing of this order, for which I hereby declare to agree that mypersonal data is stored and processed. Concept Heidelberg will onlysend me information in relation with this order or similar ones. Mypersonal data will not be disclosed to third parties (see also the privacypolicy at http://www.gmp-compliance.org/eca privacy.html).I note that I can ask for the modification, correction or deletion of mydata at any time via the contact form on this website.CountryP.O. Number (if applicable)Reservation Form: 49 6221 84 44 34structors, or speakers without notice or to cancel an event. If the eventmust be cancelled, registrants will be notified as soon as possible andwill receive a full refund of fees paid. CONCEPT HEIDELBERG will notbe responsible for discount airfare penalties or other costs incurreddue to a cancellation.Terms of payment: Payable without deductions within 10 days after receipt of invoice.Important: This is a binding registration and above fees are due incase of cancellation or non-appearance. If you cannot take part,E-Mail (please fill in)Phone/FaxZip CodeDepartmentP.O. Box 10 17 6469007 Heidelberg, GermanyCityStreet/P.O. BoxImportant: Please indicate your company’s VAT ID NumberCompany 49 6221 84 44 34 #General terms and conditionsIf you cannot attend the conference you have two options:1. We are happy to welcome a substitute colleague at any time.2. If you have to cancel entirely we must charge the following processing fees: Cancellation - until 2 weeks prior to the conference 10 %, - until 1 weeks prior to the conference 50 % - within 1 week prior to the conference 100 %.CONCEPT HEIDELBERG reserves the right to change the materials, in-MrTitle, first name, surname*FF SAP – Validation and GMP Compliance, 6-7 November 2018, Berlin, GermanyFF Virtual IT Systems in a GxP Environment, 8-9 November 2018, Berlin, GermanyReservation Form (Please complete in full)Form: ReservationCONCEPT HEIDELBERGD-69007 HeidelbergGERMANYCONCEPT HEIDELBERGP.O. Box 101764Fax 49 (0) 62 21/84 44 34If the bill-to-address deviates from the specificationson the right, please fill out here:Easy RegistrationInternet:@ e-mail:info@concept-heidelberg.de www.gmp-compliance.orgDateTuesday, 6 November 2018, 09.00 h – 18.00 h(Registration and coffee 08.30 h – 09.00 h)Wednesday, 7 November 2018, 08.30 h – 17.00 hVenueSteigenberger Hotel BerlinLos-Angeles-Platz 110789 Berlin, GermanyPhone 49(0)30 2127 0berlin@steigenberger.deFees (per delegate plus VAT)ECA Members 1,490APIC Members 1,590Non-ECA Members 1,690EU GMP Inspectorates 845The conference fee is payable in advance after receiptof invoice and includes conference documentation,dinner on the first day, lunch on both days and all refreshments. VAT is reclaimable.AccommodationCONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotels. You will receive a room reservation form when you have registered for the event. Reservation should be madedirectly with the hotel. Early reservation is recommended.Would you like to save money?If you book “SAP – Validation and GMP Complianceand “Virtual IT Systems in a GxP Environment” (8-9November 2018) simultaneously the fee reduces asfollows:ECA Members 2,790APIC Members 2,890Non-ECA Members 2,990EU GMP Inspectorates 1,690Conference LanguageThe official conference language will be English.Organisation and ContactECA has entrusted Concept Heidelberg with theorganisation of this event.CONCEPT HEIDELBERG, P.O. Box 10 17 6469007 Heidelberg, GermanyPhone 49-(0)62 21/84 44-0Fax 49-(0)62 21/84 44 .deFor questions regarding content:Dr Andreas Mangel (Operations Director)at 49(0) 62 21 / 84 44 41 or atmangel@concept-heidelberg.de.For questions regarding reservation, hotel,organisation etc.:Mr Rouwen Schopka (Organisation Manager)at 49(0) 62 21 / 84 44 13 or per e-mail atschopka@concept-heidelberg.de.WA/27122017
Virtual IT Systemsin a GxP EnvironmentSPEAKERS:Bob McDowallR.D.McDowall LimitedYves SamsonKereon AGJürgen SchmitzGSK8-9 November 2018, Berlin, GermanyLEARNING OBJECTIVES: Advantages and disadvantages ofvirtual systems in a GxP environment Benefits of virtualisation Regulations apply to virtualisation Differences between virtual systems and real systems What are the critical points- during implementation- during qualification and- during operation of virtual systems Virtualisation platform Planning and qualification of a virtualisation project Case studies from virtualisation projects Change management / configuration management anddisaster recovery From virtualisation to cloud computingThis education course is recognised for the ECA GMP Certification Programme „Certified Computer Validation Manager“.Please find details at www.gmp-certification.eu
Virtual IT Systems in a GxP Environment8-9 November 2018, Berlin, GermanyObjectivesProgramme Get an overview of technologies discussed currentlyin the pharmaceutical environment and their potential fields of application, Assess how to use and implement GMP requirementsand provisions for virtual IT systems and, whereappropriate, for cloud computing, Learn more about the qualification and use of virtualsystems in the GMP environment, and Evaluate whether the use of virtual IT systems andcloud computing would be profitable if your company.Principles of IT qualification and validation Regulatory requirements Definitions Validation and qualificationBackgroundVirtual systems, cloud computing, and GMP; does this fittogether? What are the advantages and disadvantages ofthese systems in a GMP environment? Are there any limitswith their use?The increasing use ofvirtual IT systems andcloud computing in aGMP-regulated environment is getting more andmore discussed. The virtualisation of computersystems offers a greatnumber of advantages, such as the simultaneous use ofmultiple operating systems, the simple and low-cost construction of test environments, and the improved utilisation of multi-core processors.Can these advantages also be used in a GMP environmentand which aspects have to be specifically considered fromthe “GMP view” for virtual systems and cloud computing?This event considers virtual systems and cloud computingfrom the GMP point of view and provides practicalsupport to determine measures regarding the use ofsuch systems.What is Virtualisation? Definitions Physical platform foundation requirements Software for virtualisation Virtual platform optionsBenefits of Virtualisation On demand infrastructure Speed of implementation FlexibilityRegulations apply to Virtualisation Annex 11 key points for consideration IT infrastructure shall be qualified In-house or hosted systemQualification of IT-Infrastructure General Principles of IT Infrastructure Qualification How to do qualification in a real environment vs.what to do in a virtual environment Qualification Activities Roles and responsibilities Installation and TestingPlanning of virtualisation projects User / Technical Requirements Specification Definition of the installation and deploymentapproach Definition of backup cycles and scenarios From a virtual server to a virtual farm Efficient planning Qualification planningCompliance requirements for virtual systems IT Infrastructure Platform Server Platform Qualification Virtual Platform considerations Maintaining the Qualified State during operationTarget AudienceThe event is aimed at managers in the pharmaceutical industry, suppliers and service providers that operate virtualIT systems and cloud computing in a GMP environment orintend to use them in the future.Overview of the virtualisation platform Platform components Platform operation Handling of SANs and VMsQualification of the virtualisation platform Requirements gathering Platform design Qualification planning Supporting processes
Making of a virtual data centre Specification of virtual data centre requirements Do I qualify or validate the hypervisor software? Building and qualifying a virtual data centreRisk management ASTM E 2500-07 Good Engineering Practice (GEP) Q 9 – Quality risk management GAMP 5, M 3 GEP, Qualification, Validation reconciliation NIST-SP 800-30 Risk Management for IT systems HA-OpVirtualisation of laboratory equipment / Desktopvirtualisation Use cases for virtualisation in a laboratoryenvironment Operating a virtual systemShow and tell: Virtualisation documentation Technical Requirements Specification Configuration Specifications Installation QualificationChange & Configuration Management Regulatory requirements What is a change? Definitions of change management & configurationmanagement An outline change management processDisaster recovery planning Regulatory requirements for Disaster Recovery Disaster Recovery or Business Continuity Planning? Mitigating physical faults Triggers for the plan Testing the plan Keeping the plan up to dateWorkshop: Risk-based approach to planning ofvirtualisation platformThe participants should assess and control the risksrelated to the virtualisation of some critical systems,such as DMS, CDS, ERP, LIMS, process historianFrom virtualisation to Cloud Computing What is Cloud Computing really? Abstraction of services and IT-infrastructure Virtualisation vs. Cloud Computing Recommendations for a GxP compliant CloudComputingSpeakersDr Bob McDowallR.D.McDowall Limited, Bromley, Kent, UKAnalytical chemist with over 40 yearsexperience including 15 years workingin the pharmaceutical industry and afterwards working for the industry as aconsultant. Bob is an ISO 17025 assessor and he has been involved with thevalidation of computerised systems for over 25 years andis the author of a book on the validation of chromatography data systems. He was also a contributor to the GAMPGPG IT Infrastructure control & compliance.Yves SamsonKereon AG, Basel, SwitzerlandYves is founder of Kereon AG, Basel.He is member of GAMP Europe Steering Committees, chairman and cofounder of GAMP Francophone andedited the French version of GAMP 4and GAMP 5. In 2017, Yves launchedthe e-Compliance Requirements Initiative (eCRI) with theaim to help the regulated pharmaceutical industry and itssuppliers to address and to implement accurately, consistently, and effectively the regulatory e-Compliance requirements.Dr Jürgen SchmitzGSK, Wavre, BelgiumJürgen Schmitz was from 1994 until2000 at RELAB AG and from 2000 2003 at KPMG Consulting AG responsible for computer systems validation.Between 2003 and 2015 he was in different positions at global IT QualityManagement at Novartis and Novartis Vaccines and Diagnostics. Since 2016 he is Head Quality IT and Compliance at GSK Vaccines.Social EventIn the evening of the first course day, you are cordiallyinvited to a social event. This is an excellent opportunityto share your experiences with colleagues from othercompanies in a relaxed atmosphere.
structors, or speakers without notice or to cancel an event. If the eventmust be cancelled, registrants will be notified as soon as possible andwill receive a full refund of fees paid. CONCEPT HEIDELBERG will notbe responsible for discount airfare penalties or other costs incurreddue to a cancellation.Terms of payment: Payable without deductions within 10 days after receipt of invoice.Important: This is a binding registration and above fees are due incase of cancellation or non-appearance. If you cannot take part,E-Mail (please fill in)Phone/FaxCityStreet/P.O. BoxZip CodeDepartmentyou have to inform us in writing. The cancellation fee will then becalculated according to the point of time at which we receive yourmessage. In case you do not appear at the event without havinginformed us, you will have to pay the full registration fee, even ifyou have not made the payment yet. Only after we have receivedyour payment, you are entitled to participate in the conference(receipt of payment will not be confirmed)! (As of January 2012)German law shall apply. Court of ju
– Change management – Lifecycle management – Periodic evaluation – Data Migration Audit trail in SAP Data Integrity and SAP SAP S/4 HANA in a GxP environment 6-7 November 2018, Berlin, Germany WA/27122017 This education course is recognised for the ECA GMP Certifi
