Integrating LIMS with CDS

Transcription

1 3-Day GMP Education Course Participate in 6 Workshops Integrating LIMS with CDS Foto: DRK Laboratory Information Management Systems and Chromatography Data Systems in GMP and FDA Regulated Laboratories 2 4 July 2008, Berlin, Germany SPEAKERS: Dr Akos Bartha AstraZeneca, Sweden Dr Markus Dathe Siegfried AG, Switzerland Dr Bob McDowall McDowall Consulting, UK Dr Thomas Storm Bayer Schering Pharma AG, Germany PROGRAMME: Using Excel in a Regulated Analytical Laboratory Can R&D and Production Use the Same LIMS? 21 CFR Part 11: Current Status Implementing Electronic Records and Electronic Signatures in LIMS and CDS Criteria for Manual Reintegration of Chromatographic Peaks Where to Perform Post-Integration Calculations - in Excel? - in CDS? - or in LIMS? Analytical Balances Interface to LIMS or CDS? Side-wide CDS Projects: Advantages and Disadvantages Interfacing and Validation a CDS-LIMS Interface LIMS Sample Management How to Interface an Electronic Laboratory Notebook (ELN) with CDS/LIMS SAP versus LIMS Pros and Cons Options for Retention and Archiving of CDS Records

2 Integrating LIMS with CDS 2 4 July 2008, Berlin, Germany Learning Goals Two of the major computerised systems used in GMP- and FDA-regulated laboratories are chromatography data systems (CDS) and laboratory information management systems (LIMS). However, how effective are these systems used either individually or in combination? Today s pharmaceutical companies are suffering from reduced profit margins as a result of healthcare cuts by government agencies. This requires internal efficiencies to maintain profit levels. In addition, there are regulatory drivers to maintain or improve regulatory compliance as well as submit records in electronic format instead of the traditional paper form. And regulations are being interpreted differently (e.g. FDA s GMP regulations) or being revised (e.g. 21 CFR 11 for electronic records and electronic signatures and EU GMP). How will these impact CDS and LIMS applications? The course looks at both IT and analytical issues facing analysts, managers and QA working in today s GMP- and FDA-regulated laboratories within pharmaceutical organisations. It focuses on issues that impact CDS and LIMS separately as well as when they are integrated together. The aim of this course with workshops to reinforce key learning points is to assess how to improve the effectiveness of these applications used individually as well as in combination. Target Group Analysts, Managers and Quality Assurance personnel working in GMP and FDA regulated laboratories are encouraged to attend. IT personnel working with or supporting LIMS and CDS applications would also benefit from attendance. Literature Participants of this course can purchase Dr Bob McDowall s book on Validation of Chromatography Data Systems at a 35% reduced price! You will receive the order form for this book at the conference. Programme Introduction to the Conference and the Teaching Team LIMS and CDS Business and regulatory drivers impacting the two applications Decision criteria (derived from regulatory requirements) for the selection of a CDS and/or a LIMS Impact of the April 2008 US GMP changes and their impact on LIMS and CDS Using Excel in a Regulated Analytical Laboratory Prerequisites for using Excel in a regulated environment Calculations in Excel versus calculations in CDS or LIMS Implications of using Excel DR THOMAS STORM, Bayer Schering Pharma AG Can R&D and Production Use the Same LIMS? Can you save money by implementing a single instance for both production QC and R&D laboratories? What are the similarities and differences between an R&D and production LIMS? Pros and Cons Four Compliance Lessons for Chromatography Data Systems Citations from Able Laboratories 483 Citations from Concord Laboratories warning letter Understanding the four compliance lessons from two FDA inspections of CDS in the two companies What are the implications for LIMS? WORKSHOP I Post Integration Calculation Where should the post integration calculations be performed: in Excel, CDS or LIMS? Moderator: Thomas Storm Managing Electronic Records in the Regulated Laboratory Current status of electronic records and signatures regulations FDA and EU guidance for electronic records and computerized systems Guidelines for archiving GLP records Guidelines for clinical computerized systems Implications for your LIMS / CDS DR AKOS BARTHA, AstraZeneca Implementing Electronic Signatures in CDS and LIMS How efficient is your current process? Process Redesigning LIMS and CDS for Electronic Signatures Where should electronic records be electronically signed in a process?

3 WORKSHOP II Process Redesign for Electronic Signature Implementation Case study of laboratory CDS and LIMS process flows for improvement by the course. Identify where electronic signatures are applied. Moderator: Dr Bob McDowall How to Define Electronic Records in LIMS and CDS GMP Predicate rule requirements for laboratory records Identification of electronic records based on system and record use Utilizing record lifecycle descriptions DR AKOS BARTHA, AstraZeneca WORKSHOP III Identifying Electronic Records for CDS Groups will learn how to perform a step-by-step identification and lifecycle description of electronic records for a CDS. Moderator: Dr. Akos Bartha Integration and Manual Reintegration of Chromatographic Peaks When and When Not? Automatic and manual integration Integration for assays (e.g. API) Considering impurities Reintegration of standards DR THOMAS STORM, Bayer Schering Pharma AG WORKSHOP IV Chromatographic Reintegration Groups draw up criteria for manual reintegration of assay (e.g. API) and impurities. Moderator: Dr Thomas Storm Analytical Balances Interface to LIMS or CDS? Pros and cons of two workflows How can balances be integrated? Implementing a Site-Wide Client-Server-Based CDS Project Advantages and disadvantages of a site-wide project Architecture / Validation approach Setting up User Requirements Training issues DR THOMAS STORM, Bayer Schering Pharma AG Interfacing LIMS and CDS Defining the master and the slave in the process flow Implications of the interfacing, e.g. normal results and OOS, etc. Validating a CDS LIMS Interface What to do? And how to do it? WORKSHOP V Developing Validation Strategies for Your Laboratory Cost effective approaches for validation of LIMS and CDS: single installation or global roll-out, main or satellite site? Moderator: Dr Bob McDowall LIMS Sample Management Sample management how far do you want to manage? Using bar code labels for sample identification Labelling storage locations and integrating with sample management Is integration with other applications outside the laboratory required? Where Does an Electronic Laboratory Notebook (ELN) fit with CDS and LIMS? What is an ELN and what functions does it automate? Enforced Compliance by ELN How can it be interfaced with a CDS and / or LIMS? Facilitated Debate: LIMS or ERP? The case for ERP (SAP) LIMS functionalities of SAP-QM: why you don t want a LIMS when you have SAP already Integrated Supply Chain ERP: Quality Management in the business context The case for LIMS Why you must select a LIMS instead ERP Designed for the laboratory by the laboratory Handling laboratory problems LIMS and CDS Technical Architectures: Pros and Cons How big is big? Why infrastructure matters Fat and thin clients and servers Standard infrastructure vs. island approach Terminal emulations: Citrix & Co. Structures and redundancies Dos and Don ts

4 Changing a CDS or LIMS What Do You Do with the Old Data? Why secure electronic data and system documentation when retiring the old system? Challenges and options for records retention when upgrading your system Advantages of data migration tools provided by vendors DR AKOS BARTHA, AstraZeneca WORKSHOP VI Options for Retention and Archiving of CDS Records What should you do with the old system and data when changing systems? Applying a risk assessment to justify your decision Can the outcome be applied for all situations? Moderator: Dr Akos Bartha Facilitated Discussion: Designing PQ Test Cases for LIMS and CDS Identifying regulatory requirements for computerised systems Testing intended use for both LIMS and CDS Identifying validation versus procedural controls Testing adequate size for CDS and LIMS Social Event The European Compliance Academy cordially invites the conference participants and speakers for a social event on Wednesday evening. During an informal dinner you will have the opportunity to meet and discuss the hot topics of the day with your colleagues. Speakers Dr Akos Bartha AstraZeneca, Södertälje, Sweden Chemical engineer and analytical chemist with a background of 10 years academic research, and another 17 years industry experience in pharmaceutical quality control and quality assurance, laboratory automation, equipment qualification and computer system validation. Senior Consultant and subject matter expert for electronic records management and archiving. Dr Markus Dathe Siegfried AG, Zofingen, Switzerland Analytical chemist with over 15 years of practical experience with computers, analytics, and quality systems. Markus held several positions in Quality Control and Assurance with Novartis Pharma and Syngenta Agro. Markus has been leading global CDS and LIMS/QA projects and is now Quality Assurance Manager Actives at Siegfried Ltd. Dr Bob McDowall McDowall Consulting, Bromley, Kent, UK Analytical chemist with over 30 years experience including 15 years working in the pharmaceutical industry. Principal of McDowall Consulting, UK. Bob was the 1997 LIMS Awardee for advances to the subject and teaching. Dr Thomas Storm Bayer Schering Pharma AG, Berlin, Germany Analytical chemist, since 2001 at Schering AG/Bayer Schering Pharma AG, Berlin, Analytical Development. Work Areas are CDS, HPLC methods development, HPLC/MS impurity profiling, quality control for development candidates, excipients, and electronic raw data archival. Course Exhibition Opportunity for LIMS and CDS Suppliers LIMS and CDS suppliers are invited to exhibit their systems and products during the three course days. Please contact Nicole Bach at CONCEPT HEIDELBERG (bach@ concept-heidelberg.de; Phone +49 (0) 6221/ ) for further information about the opportunity to rent a stand space at the conference exhibition.

5 Conference language The official conference language will be English. Organisation and Contact CONCEPT HEIDELBERG P.O. Box D Heidelberg, Germany Phone +49 (0) 62 21/ , Fax +49 (0) 62 21/ How Do You Become a Member of ECA? By participating in one of the European Compliance Conferences or Courses marked with ECA, you will automatically become a member of ECA for two years free of charge. Conferences and Education Courses organised by ECA will be realised in co-operation with CONCEPT HEIDELBERG. More information about ECA can be obtained on the Website For questions regarding content: Dr Günter Brendelberger (Operations Director) at / , or per at brendelberger@concept-heidelberg.de. For questions regarding reservation, hotel, organisation etc.: Ms Nicole Bach (Organisation Manager) at / , or per at bach@concept-heidelberg.de. About CONCEPT HEIDELBERG Founded in 1978, CONCEPT HEIDELBERG is the leading organiser of seminars on pharmaceutical production, quality control, quality assurance and GMP in Europe. This year more than 240 events will be organised by CONCEPT HEI- DELBERG. ECA has entrusted CONCEPT HEIDELBERG with the organisation of its events. What Is ECA? The European Compliance Academy (ECA) is an independent educational organisation chaired by a Scientific Advisory Board with members of the pharmaceutical industry and regulatory authorities. The ECA will provide support to the Pharmaceutical Industry and Regulators to promote the move towards a harmonised set of GMP and regulatory guidelines by providing information and interpretation of new or updated guidances. What Are the Benefits of ECA? First benefit: During the membership, you enjoy a 10 % discount on the regular participation fee of any European Conference organised by ECA in co-operation with CONCEPT HEIDELBERG. GMP Certification Programme This seminar is recognised within the GMP Certification Programme. By attending selected seminars, the participant can acquire an additional certificate. We offer the following certification modules: Certified Quality Assurance Manager Pharmaceutical Production (ECA) Certified Quality Assurance Manager API Production (ECA) Certified Quality Control Manager (ECA) Certified Pharmaceutical Engineering Manager (ECA) Certified Computer Validation Manager (ECA) Certified Regulatory Affairs Manager (ECA) Certified Validation Manager (ECA) On the internet at you will find a text explaining which seminars are recognised for which certificates. Or you send an to info@gmp-compliance.org or a fax to with the request for information about the GMP Certification Programme. We will then send you our brochure on the topic. Second benefit: The GMP Guideline Manager Software with a large number of guidelines, e.g. EC Directives, FDA Guidelines, ICH Guidelines, will be forwarded to you when you are using your membership for a conference registration.

6 Reservation Form (Please complete in full) Integrating LIMS with CDS 2 4 July 2008, Berlin, Germany * Mr. * Ms. Title, first name, surname Company Department Important: Please indicate your company s VAT ID Number Purchase Order No, if applicable Street/P.O. Box City Zip Code Country Phone/Fax (please fill in) # Date Wednesday, 2 July 2008, 9.00 h h (Registration and coffee h 9.00 h) Thursday, 3 July 2008, 8.30 h h Friday, 4 July 2008, 8.30 h h Venue Steigenberger Hotel Berlin Los-Angeles-Platz 1 D Berlin, Germany Phone +49 / (0) Fax +49 / (0) Fees Non-ECA Members 1,990.- per delegate plus VAT ECA Members 1,791.- per delegate plus VAT, EU GMP Inspectorates per delegate plus VAT APIC Members 1,890,- per delegate plus VAT (does not include ECA membership) The conference fee is payable in advance after receipt of invoice and includes conference documentation, dinner on the first day, lunch on all days and all refreshments. VAT is reclaimable. Accommodation CONCEPT has reserved a limited number of rooms in the Steigenberger Hotel Berlin. Reservation should be made directly with the hotel not later than 3 June You will receive a room reservation form when you have registered for the course. Please use this form for your room reservation or be sure to mention VA 5597 ECA Course to receive the specially negotiated rate for the duration of your stay. Early reservation is recommended. Registration Via the attached reservation form, by or by fax message. Or you register online at General Terms of Business If the bill-to-address deviates from the specifications on the right, please fill out here: CONCEPT HEIDELBERG P.O. Box Fax +49 (0) 62 21/ D Heidelberg GERMANY If 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 % of the registration fee. until 1 week prior to the conference 50 % of the registration fee. within 1 week prior to the conference 100 % of the registration fee. CONCEPT reserves the right to change the materials, instructors, or speakers without notice or to cancel an event. If the event must be cancelled, registrants will be notified as soon as possible and will receive a full refund of fees paid. CONCEPT will not be responsible for discount airfare penalties or other costs incurred due 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 in case of cancellation or non-appearance. If you cannot take part, you have to inform us in writing. The cancellation fee will then be calculated according to the point of time at which we receive your message. In case you do not appear at the event without having informed us, you will have to pay the full registration fee even if you have not made the payment yet. You are not entitled to participate in the conference until we have received your payment (receipt of payment will not be confirmed)!