Computerised Systems in Analytical Laboratories. cgmp Compliance Trends in Analytical Laboratories. PharmaLab

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1 Computerised Systems in Analytical Laboratories cgmp Compliance Trends in Analytical Laboratories These conferences are part of 17 PharmaLab Congress & Exhibition Analytics Bioanalytics Microbiology Düsseldorf, 7/8 November SPEAKERS ULLA BONDEGAARD Novo Nordisk, Denmark PETER J. BOOGARD Industrial Lab Automation, The Netherlands DR WOLF-CHRISTIAN GERSTNER Genui, Germany CHRISTOPHE GIRARDEY wega Informatik, Switzerland NIEK JANSSEN ALTRAN Netherlands LEO LEINEWEBER Technical Auditor/ Inspector, Germany DR LARS LUEERSEN CLS Behring Recombinant Facility AG, Switzerland ROBERT LUTSKUS LONZA, USA ERIC DE MAESSCHALCK UCB, Belgium DR DANILO NERI PQE, Italy 7/8 November 2017, Düsseldorf/Neuss, Germany HIGHLIGHTS: Computerised Systems in Analytical Laboratories A risk-driven Approach to Data Integrity Regulatory Requirements Update (EU and US) Audit Trail Review Competing in a Data-driven World - Transforming Scientific Information into Actionable Insights Case Study: Entering the Paperless and Digital Era at UCB BioPharma From Sample to Decision: Role of Informatics in Laboratory Workflows How Informatics will enable better Quality - One Process, One Record, One Solution cgmp Compliance Trends in Analytical Laboratories Current Experiences from GMP Inspections in QC Labs Forced Compliance: Turning the FDA quality metrics initiative into value for your lab Risk-based Approach to Sampling according to EU GMP Chapter 6 does QC have to take the sample? Case Study Handling OOT Results Case Studies: ALCOA Metrics for Data Integrity Update 2017: New challenging ANVISA Requirements to Method Validation and Method Transfer (Brazil) Image: Labor L+S

2 Computerised Systems in Analytical Laboratories 7 November 2017, Düsseldorf/Neuss, Germany Objectives It is the aim of this Conference to discuss the different applications of LIMS, ELN, LES, SDMS, PLM, ERP, etc. and to show how LIMS can be implemented in today s QC and R&D environment. Technical issues will also be addressed, e.g. how to connect analytical instruments, or how to link Electronic Laboratory Notebooks (ELNs) and LIMS. This year the current data integrity challenges in analytical labs will especially be addressed: which are the actual regulatory expectations (WHO, MHRA and FDA) and how to implement cgmp compliant data record management systems in practice. The challenges of Audit Trail Reviews and how to implement these controls in a practical manner will be another focus area of this course. And a paperless laboratory case study will show how paperless processes are a key to achieve Data Integrity compliance. A team of experienced speakers will provide you the opportunity to learn more about their practical experiences and to discuss possible pitfalls and how to avoid these. Background The paperless laboratory has been a dream in QC and R&D for a number of years. It offers the possibility to improve and accelerate the analytical processes in the laboratory on one hand, and to save money and costs on the other hand. The power of a paperless lab is the ability to enable organizations to implement self-documenting processes that produce GxP-compliant documentation which eliminates unnecessary tasks from the workflow, resulting in a significant reduction of the cost of non-compliance and optimization of the corporate Cost of Goods Sold (COGS). But the integrity and security of laboratory data, records, results, and information is fundamental for running a successful GMP regulated QC laboratory. This applies for the classic analytical lab as well as for microbiology or other labs both, for in-house labs or contract labs. To develop a secure, stable and validable laboratory information management system (LIMS) - maybe even compatible with an already existing system - is a real challenge for LIMS suppliers. And the successful implementation and validation of a LIMS in compliance with GAMP and GMP requirements (EU Annex 11, US 21 CFR Part 11, PIC/S, etc.) is a huge challenge for all pharmaceutical QC and R&D departments. Moderator Target Audience Social Event Peter J. Boogaard, Industrial Lab Automation This conference is aimed at the following attendees: Laboratory personnel working in GMP laboratories in the pharmaceutical industry, contract research organisations, contract manufacturing organisations and API manufacturers Employees involved in the implementation and use of LIMS Quality Assurance /Quality Control (Quality Manager, Quality Systems Project Leader, Laboratory Head, QA Director) Lab Information Management ELN and LIMS Project Leader IT, Informatics and Support LIMS Suppliers On the evening of the first congress day, on 7 November 2017, all congress delegates and speakers are invited to a Get together in the Congress Center. Take advantage of this opportunity for an information exchange and enjoy the laid-back atmosphere and the entertainment programme.

3 Programme A risk-driven Approach to Data Integrity Regulatory Requirements Update (EU and US) Audit Trail Review NIEK JANSSEN, ALTRAN Netherlands According to the latest data integrity guidelines firms should implement meaningful and effective strategies to manage their data integrity risks based upon their process understanding and knowledge management of technology and business models. This key note presentation will provide a practicable risk management approach to ensure data integrity throughout the data life cycle. Importance of a Laboratory Data Governance policy Update of regulatory requirements FDA and EU Strategies how laboratory data standards may support reduction of validation efforts PETER J. BOOGAARD, Industrial Lab Automation Why are audit trails so frequently mentioned in regulatory observations? What are the true challenges of meeting current regulatory audit trail expectations? Which controls are required at a minimum to review audit trails? How to implement these controls in a practical manner? Can audit trails also serve other purposes? NIEK JANSSEN, ALTRAN Netherlands Competing in a Data-driven World:Transforming Scientific Information into Actionable Insights Are we ready to adopt Internet of Lab Things in a regulatory setting (IoLT)? What can we learn from a smart factory concept in science? Impact of industry 4.0 for lab operations Will Q10 help as a guideline to apply new approaches for data integrity and data governance? Impact of data creator s vs data consumer s mind-set. Learnings from other industries Examples of automated self-documenting data capture processes in data lifecycle to reduce DI effort New approaches to use audit trail as source to improve operational excellence PETER J. BOOGAARD, Industrial Lab Automation Case Study: Entering the Paperless and Digital Era at UCB BioPharma Case Study: Validation of a global Lab Execution System How Informatics will enable better Quality - One Process, One Record, One Solution The challenge of simultaneous implementation of several ELNs : ensuring efficient paperless data flows through proper systems integration Improving laboratory efficiency by direct data capture from equipment, automatic check of reagents and solutions at analysis time and self-documenting processes Streamlining communication between laboratory and manufacturing area: designing real time bi-directional data transfer Integrating new technologies: smartphone apps, Kinect technology, Google Glass: what did not work and what was a success? Paperless processes : a key to demonstrate compliance to Data Integrity Requirements. What s next : IoT (Internet of Things)? ERIC DE MAESSCHALCK, UCB CHRISTOPHE GIRARDEY, wega Informatik How to waste less time in coordinating and reviewing data from multiple sources Faster Release by combining lab information and production records New approaches to workflow and role-based analytics How to apply technology trends and integration approaches required to achieve this vision ROBERT LUTSKUS, Lonza

4 cgmp Compliance Trends in Analytical Laboratories 8 November 2017, Düsseldorf/Neuss, Germany Objectives Background It is the aim of this course to address all those GMP Compliance issues that are currently discussed as hot topics in analytical quality control laboratories and during GMP/FDA Inspections. This course will give an update about the actual regulatory requirements (EU, US, WHO, etc.) and will show how these requirements can be put into practice. In addition this course will look at scientific and regulatory trends to be expected in the future. Due to changing regulatory requirements pharmaceutical quality control units are continuously facing new challenges. There are many regulatory requirements relevant for the pharmaceutical quality control, both in EU and in the US, for instance EU GMP Guide, 21 CFR Part 210/211 (USA), EMA and FDA Guidances, WHO Recommendations and Pharmacopoeias (Ph.Eur., USP, JP). Laboratory Managers and Analytical Scientists must be familiar with all these GMP-related topics and must be aware of the latest updates and the current interpretation of all these guidance documents. In addition, analytical QC laboratories are increasingly in the focus of GMP inspections, both in Europe and in the US. For instance after FDA inspections, many laboratory-specific citations can be found in 483s and Warning Letters. And many findings related to the laboratory can also be found after inspections of European GMP supervisory authorities. Topics that will be addressed are: Current Experiences from GMP Inspections in QC Labs from an GMP Inspectors Perspective Forced Compliance: Turning the FDA quality metrics initiative into value for your lab Risk-based Approach to Sampling according to EU GMP Chapter 6 does QC have to take the sample? Case Study Handling OOT Results Case Studies: ALCOA Metrics for Data Integrity Update 2017: New challenging ANVISA Requirements to Method Validation and Method Transfer (Brazil) Moderator Target Audience Ulla Bondegaard, Novo Nordisk This conference will be of significant value to Laboratory managers Quality control managers Qualified Persons (QPs) Analytical scientists Senior laboratory staff from quality control units in the pharmaceutical industry (routine QC and in research and development) who are responsible for GMP Compliance in the analytical laboratory. This course is also intended for employees in Quality Assurance and from contract labs.

5 Programme Challenges for QC Networks Current Experiences from GMP Inspections in QC Labs Forced Compliance: Turning the FDA Quality Metrics Initiative into Value for your Lab Risk-based Approach to Sampling DR SVEN M. DEUTSCHMANN, Roche Diagnostics, Chairman ECA Pharmaceutical Microbiology Group Experiences with implementation of chapter 6 of the EC GMP guideline Handling of OOS Transfer of methods Reference substances Sampling LEO LEINEWEBER, Technical Auditor / Inspector, Germany Background on FDA quality metrics program (short) The effects of forced compliance and the Forced-compliance-Paradigma Implications for your QC lab The value of compliance for the lab Approach to derive maximum value out of compliance metrics Pitfalls to avoid when introducing metrics DR WOLF-CHRISTIAN GERSTNER, Geniu Sampling plans should be based on a risk management approach (EU GMP Chapter 6) Do the laboratory personnel collect the samples? Requirements to labelling and handling of samples. A practical approach ULLA BONDEGAARD, Novo Nordisk Image: Labor L+S Case Study Handling OOT Results ALCOA Metrics for Data Integrity Update 2017: New challenging ANVISA Requirements to Method Validation and Method Transfer (Brazil) DR LARS LUEERSEN, CSL Behring Recombinant Facility AG Regulatory expectations set forth in the latest Data Integrity Guidances issued by PIC/S, FDA, MHRA, WHO ALCOA+ control measures recommended to be included in a Data Governance System to be embedded in the Quality System of Life Science companies Assessment of current practices against these measures to identify potential violations to the integrity of Regulated Data and to define risk-based corrective actions, which allow the company to mitigate the resulting Regulatory exposure. Case studies related to the data created and managed either on electronic and paper format within the laboratory environment Metric which allow the company to assess the compliance level and monitor the relevant mitigation actions DR DANILO NERI, PQE New requirements about validation of analytical procedures Extra requirements to method transfer Additional expectations of the Brazilian authorities ULLA BONDEGAARD, Novo Nordisk

6 Speakers ULLA BONDEGAARD, Novo Nordisk, Bagsværd, Denmark Ulla Bondegaard (M.Sc. Chemical Engineering) has many years of experience in management of quality control laboratories covering a wide range of analytical techniques (HPLC, GC, AAS, AA, IR, Elisa, etc.). Currently she is responsible for maintaining cross-organisational (and cross-country) laboratory processes in Novo Nordisk, including general laboratory GMP, sampling and transfer of analytical procedures. PETER J. BOOGAARD, Industrial Lab Automation, The Netherlands Peter Boogaard has extensive experience in laboratory management to enable cross-functional collaboration between research, development, quality assurance and manufacturing corporations. Peter is founder of Industrial Lab Automation. He is publishing in international magazines and contributes in several industry advisory boards. Peter is member of the ISPE GAMP community. Peter is Dutch citizen and studied analytical chemistry in Delft. DR WOLF-CHRISTIAN GERSTNER, Geniu, Hamburg, Germany Managing Director of Geniu. 10+ years consulting experience for Pharma QA and QC (incl. McKinsey); Former Leader of the Pharma Quality and Compliance Benchmarking, which served as reference for the FDA quality metrics initiative; Current research topic with focus on Pharma Compliance Crises (article submitted to the Academy of Management). CHRISTOPHE GIRARDEY, wega Informatik AG, Switzerland Christophe Girardey manages the group CSV & QA at Wega Informatik. He is involved in different Lab Systems Projects (Lab Execution System, LIMS, ) as Validation Lead or Business Analyst across Switzerland and Germany. He also works frequently on more strategical projects (defining/improving CSV processes, conduct audits for validation of key systems as preparation for FDA Audit, defining/improving Data Integrity process, ) within Pharma companies and supports as well SW vendor/instrument Manufacturer to improve their process for GxP area. NIEK JANSSEN, ALTRAN Netherlands Niek is a well versed Life Sciences Consultant who has been active in life sciences and related industries for over 16 years. With a strong background in Computerised System Validation (CSV) and Industrial IT he has supported many companies in moving to a paperless factory environment while complying with relevant GxP regulations. ERIC DE MAESSCHALCK, UCB, Belgium Eric De Maesschalck graduated in Clinical Chemistry and Medical Biology. He has spent 30 years in highly regulated pharmaceutical companies: GSK, Pfizer, Phibro Animal Health and UCB BioPharma. Eric de Maesschalck has 27 years of experience in computerized systems qualification and validation including IT infrastructure (GMP, GCP, GLP, GPvP) and his current position at UCB Pharma is Head of Global e-analytics, Corporate Analytical Sciences, where he has to define the long term strategy for, and ensure the correct integration of, the computerized systems landscape supporting commercial and development analytical laboratories implemented across UCB sites (e.g. GLIMS, ELNs, statistical application, central chromatography, scientific data management system, etc.). LEO LEINEWEBER, Technical Auditor/ Inspector, Münster, Germany Leo Leineweber studied Chemical Engineering at the University of Applied Sciences in Steinfurt and Pharmacy at the University of Münster, Germany. Since 2002 Leo Leineweber is Head of laboratory within the OMCL D-NRW located at the NRW Centre for Health of the federal state Nordrhein-Westfalen (lzg.nrw) in Münster. Leo Leineweber is Member of EFG 11 (Computerised Systems Working Group), has participated in more than 200 GMP-inspections (focus: chemical and biological laboratory and computerised systems) and approx. 15 EDQM Audits according to ISO DR LARS LUEERSEN, CSL Behring Recombinant Facility AG, Bern, Switzerland Senior Manager Chemical Quality Control und Global Tech Transfer PM with more than 10 Years of intensive Pharma and GMP Experience. Specialist in Qualification, Validation and Transfer of Analytical Test Methods and Systems and expert in Quality Control and Project Management. ROBERT LUTSKUS, LONZA, USA Robert Lutskus is the Global Product Delivery Manager for MODA EM. He has been a MODA SME for over 9 years, and working in QC laboratories for over 15 years. DR DANILO NERI, PQE, Italy In over 20 years of experience, Danilo has managed the validation process for the Computerised System used in the Life Science environment (e.g. ERP, MES, LIMS, EDMS, ecrf) focusing on Data Integrity requirements and he has supported the implementation of Quality Systems for the IT governance. As PDA-certified Auditor of Computer Products Suppliers, Danilo has executed many audits to Computer Products Suppliers. In the last years, he has presented a number of lectures related to Data Integrity in international congresses.

7 Agenda Time Computerised Systems in Analytical Laboratories Tuesday, 7 November 2017 cgmp Compliance Trends in Analytical Laboratories Wednesday, 8 November 2017 Time 9.00 h 9:15 h Welcome and Introduction Welcome and Introduction 9.00 h 9:15 h 9.30 h A Risk-Driven Approach to Data Integrity Challenges for QC Networks 9.30 h Niek Janssen, ALTRAN Netherlands Dr Sven M. Deutschmann, Roche Diagnostics, 9:45 h Chairman ECA Pharmaceutical Microbiology Group 9:45 h h h 10:15 h Coffee Break Coffee Break 10:15 h h h 10:45 h 10:45 h h Regulatory Requirements Update (EU and US) Current Experiences from GMP Inspections in QC Labs h Peter Boogaard, Industrial Lab Automation Leo Leineweber, Technical Auditor / Inspector, Germany 11:15 h 11:15 h h h 11:45 h Forced Compliance: Turning the FDA Quality Metrics Initiative into Audit Trail Review 11:45 h Value for Your Lab Niek Janssen, ALTRAN Netherlands Dr Wolf-Christian Gerstner, Geniu h h 12:15 h 12:15 h h h 12:45 h 12:45 h h Lunch Break Lunch Break h 13:15 h 13:15 h h h 13:45 h 13:45 h h Competing in a Data-driven World - Transforming Scientific Risk-based Approach to Sampling h Information into Actionable Insights Ulla Bondegaard, Novo Nordisk Peter Boogaard, Industrial Lab Automation 14:15 h 14:15 h h h 14:45 h Case Study: Entering the Paperless and Digital Era at UCB BioPharm Case Study: Handling OOT Results 14:45 h Eric De Maesschalck, UCB Dr Lars Luerssen, CSL Behring Recombinant Facility AG h h 15:15 h 15:15 h h Coffee Break Coffee Break h 15:45 h 15:45 h h h 16:15 h Case Study: Validation of a global Lab Execution System ALCOA Metrics for Data Integrity 16:15 h Christophe Girardey, wega Informatik Dr Danilo Neri, PQE h h 16:45 h 16:45 h h How Informatics will enable better Quality - One Process, One Record, One Solution Update 2017: New challenging ANVISA Requirements to Method Validation and Method Transfer (Brazil) h 17:15 h Robert Lutskus, Lonza Ulla Bondegaard, Novo Nordisk 17:15 h h h 17:45 h Final Discussion Final Discussion 17:45 h 18:00 h 18:00 h h Social Event (7 November) h

8 Easy Registration Reservation Form: CONCEPT HEIDELBERG P.O. Box Heidelberg Germany Reservation Form: info@concept-heidelberg.de Internet: Dates Tuesday, 7 November 2017, h Wednesday, 8 November 2017, h (Registration Monday, 6 November, h and Tuesday, 7 November/Wednesday, 8 November h) Venue Swissôtel Düsseldorf / Neuss Rheinallee Neuss, Germany Tel.: +49 (0) Fax: +49 (0) us.neu02@gchhotelgroup.com Fees (per delegate plus VAT) 690,- ( 345,- for EU GMP Inspectors) for one day ticket 1.380,- ( 690,- for EU GMP Inspectors) for two days ticket The conference fee is payable in advance after receipt of invoice and includes lunch on that day/on both days as well as beverages during the event and during breaks. It also includes the Social Event on the evening of the first congress day. VAT is reclaimable. Your registration also entitles you to participate in all other PharmaLab Congress conferences during the day of your conference/during the two days. 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