Reducing Time, Costs and Risks Involved in Software Validation Meeting Regulatory and Business Requirements through Effective Risk Management

Transcription

1 Regulatory Compliance Workshop Group 2005 European Software Validation WORKSHOP A 2-Day European Workshop for those working in the Biotechnology, Pharmaceutical and Medical Device Industries Reducing Time, Costs and Risks Involved in Software Validation Meeting Regulatory and Business Requirements through Effective Risk Management The Key Questions: Question: Is it taking you too long to validate your software? Question: How do you cut the costs and time for software validation? Question: Should companies invest in Commercial-off-the-Shelf (COTS) or Bespoke systems, and why? The cost of software validation is steadily increasing and, in some instances, industry sources claim it is spiraling out of control. There is a general consensus that healthcare companies should be implementing commercial off the shelf (COTS) applications and avoid developing bespoke systems whenever possible. After all, healthcare organisations are in the business of developing and manufacturing products - typically they are NOT in the business of software development. During this workshop a leading team of experts will tackle the difficult questions industry is trying to get to grips with and explain what you must do to ensure your systems are compliant with the regulations, but in a more cost effective way. Topics to be covered include: Understand How to Select Appropriate Risk Based Controls for Your Software Validation How to Apply Risk Based Controls Interpreting Global Regulations and Guidelines for Validation of Software Problems Encountered in Trying to Remain Compliant with the FDA and EU Regulations Best Practice and Cost Effective Methods of Validation Advantages and Disadvantages of Commercial vs. Bespoke Software Limited to 40 Attendees Includes 6 interactive WORKSHOPS that will use real CASE STUDY examples: WORKSHOP 1 - Understanding what is COTS and Configurable COTS software WORKSHOP 2 - Saving Time and Costs through Process Optimisation WORKSHOP 3 - Writing Effective User and System Requirements WORKSHOP 4 - Understanding the Principles of Failure Mode Effect Analysis WORKSHOP 5 - Selecting and Implementing Appropriate Risk Based Controls WORKSHOP 6 - Evaluating the Impact of Operating System Hot Fixes Media Partners Pharma IT Solution Partner Thursday, 1 st & Friday, 2 nd December 2005 Hilton London Olympia, UK To download a FULL comprehensive 5-page brochure please go to

2 Reducing Time, Costs and Risks Thursday, 1st and Frida Introduction to the Software Validation Workshop This opening session will set the scene for the 2 day course, introducing the speakers as well as the topics that will be addressed. The speakers will also use this opportunity to ask the audience what their experience is and what they hope to learn from the course. It is also the best opportunity to find out exactly what questions the attendee s need addressed. Introduction to the workshop programme Introducing the teaching team The common problems with validation and risk management The question of regulatory compliance The big issue of cost and time The software options available for implementation Software Validation: Regulatory Requirements vs. Business Requirements In this presentation the speaker will explain what you must, ought and should do and the pros and cons of the ways industry currently validates the software it uses. The regulations and guidance for validation of computerised systems Deriving business and regulatory benefits from software applications Disadvantages of GAMP 4 V model for COTS and bespoke software Implementation vs. development of software Bespoke software and it s advantages and problems Life cycle models for COTS and configurable COTS (GAMP 3 and 4) software Practical Risk Management for commercial software how much validation should I do? Pros and Cons for Choosing COTS vs Bespoke Software The COTS problem is not as simple as to just adopt commercial software. Certainly we can save money by using COTS and the validation is simpler, but there are license fees, enforced upgrades, one size fits all problems and these are real obstacles. This presentation will focus on the benefits and problems when adopting COTS within organisations. Why choose COTS? Key Features of COTS Documenting the Reasoning for COTS selection Rule of Thumb Examples of COTS software Pros and cons of COTS software Cost and time benefits Comparisons with Bespoke systems Useful Links to COTS WORKSHOP 1: Understanding and classifying what is COTS and Configurable COTS software Attendees will discuss how to decide whether a given software is a COTS or custom configurable package. Participants will split up into working groups for laboratory, secondary pharmaceutical production and clinical areas and will compile a list of COTS from their field. All groups will report back to the workshop to reach consensus. VALIDATION ESSENTIALS: Process Redesign for Software Implementation In this session what is meant by Process Redesign will be explained. How you should apply this technique before implementing either configurable COTS or bespoke software and the benefits that will result. Understanding what is a process and why it is important for software implementation Do we automate the current ways of working or optimise the process? Why you cannot automate a paper based process effectively Generating business benefits from the redesign by using electronic signatures WORKSHOP 2: Saving Time and Costs through Process Redesign Attendees will break into groups and will be asked to review and improve process workflow for their GxP discipline. All groups will report back their process improvements and suggested benefits and discuss with the teaching team. VALIDATION ESSENTIALS: Writing User and System Requirements This presentation will emphasise the need for having two User Requirement Specifications for configurable COTS systems and what constitutes a testable or verifiable user requirement Risk Management: documenting the intended purpose of the system Why you need two URS documents: One to select a system and another URS to validate it How to write testable or verifiable user requirements WORKSHOP 3: Writing Effective User and System Requirements Attendees will review user and system requirements and comment on any improvements necessary. All groups will report back to the workshop and discuss their findings with the teaching team. Registration: 8.45 Start of Works To Register call +44 (0) or fax +44 (0)

3 Involved in Software Validation y, 2nd December 2005 VALIDATION ESSENTIALS: Risk Based Controls for Electronic Records How to identify electronic records generated by GxP systems Not all GxP records are critical: identifying high medium and low risk records Range of controls for electronic records WORKSHOP 4: Selecting and Implementing Appropriate Risk Based Controls Attendees will be presented with a GxP system and the records it generates and will be asked to select the controls appropriate to the risk. Groups will discuss and justify the approaches taken and discuss their findings with the teaching team. VALIDATION ESSENTIALS: Risk Management Approach that can be used for Software Validation Hazard Analysis is one of the most critical functions in the Software Development Lifecycle (SDLC). A project s Hazard Analysis serves as a road map for developing an appropriate SDLC. Without a properly implemented Hazard Analysis, developing the most effective software validation effort may be in jeopardy. This presentation will explain: ISO overview: an outline of the overall risk management process Risk assessment methodologies available for software validation Overview of Failure Mode Effect Analysis and how it can be used effectively when validating software WORKSHOP 5: Understanding How the Principles of Failure Mode Effect Analysis when Validating Software Presented with a URS to assess risk, the participants will undertake a FMEA assessment and identify where the design needs to be improved, procedures will be needed and where testing is required. Groups will report back and discuss their findings with the teaching team. Translation of Guidelines / Rules / Regulations and Good Business Practices into Standard Operating Procedures (SOPs) A company might have good practices in place when it comes to validation of software, but they need to write them down in SOPs for documentation / internal guidance and training purposes. This presentation will cover SOPsystem design, SOP writing, documentation practices, technical topics to be covered regarding validation and risk management of software. IT Infrastructure Environment for Commercial-Off-the- Shelf (COTS) Software The environment in which the software is used is a vital factor in determining the amount of necessary validation required. This presentation will explain what you should consider before validation takes place and the problems you are likely to encounter. Network Safety (physical, logical, antivirus) File server Client uniformity (hardware, software) Stripping OS Date/Time synchronization Shared Active Directory System Documentation System Management Organisation External Support IT Infrastructure Qualification VALIDATION ESSENTIALS: FDA Cybersecurity Guidance for Off the Shelf Software The FDA have recently released guidance for security governing the use of Commercial-Off-the-Shelf (COTS) software. This presentation will explain what route the FDA are taking with regards commercial software and what other guidance we can expect to see in the future. Overview of the guidance for networked medical devices and how it can be applied to pharmaceutical organizations NIST SP suggested guidance for handling operating system security patches WORKSHOP 6: Evaluating the Impact of Operating System Hot Fixes Attendees will be presented with operating system hot fix change requests to evaluate the impact on their GxP regulated computerised system. Groups will report back and discuss the approaches with the teaching team. Networking Drinks Reception A Networking Drinks Reception will follow after every WORKSHOP allowing attendees the chance to discuss the day s proceedings with speakers and other attendees, and view all the exhibits. LIMITED to 40 ATEENDEES ONLY! Due to the nature of the workshops, this event is limited to 40 attendees only. The workshops are designed to provide maximum interaction between expert speakers and delegates. hop: 9.15 End of Workshop: or info@rcwg.org or register online at

4 Interactive Training: What Every Delegate Will Receive Due to the nature of the workshops it is Limited to 40 attendees. The workshop is designed to provide maximum interaction between expert speakers and the delegates Documentation: CD ROM: Certificate of Attendance: Book: Every attendee will receive a set of documentation which contains hard copies of the presentations and workshop material Every attendee will receive a CD ROM which contains electronic copies of all the presentations and workshop material PLUS relevant examples, templates, articles, guidelines and lots more material directly and indirectly relevant to the course and so it acts as an excellent future reference. The FDA and European Regulatory Agencies EXPECT those working in areas governed by GMP, GLP and GCP to DEMONSTRATE they have had proper training in areas of regulatory compliance. EVERY delegate will receive a Certificate of Attendance for their training portfolio. Every attendee will receive a FREE copy of Dr Bob McDowall s NEW book titled Validation of Chromatography Data Systems published by the Royal Society of Chemistry normally retailing at 80. Application to attendees Situation Discussion Presentations Our Philosophy Reinforcement of Theory Theory & General Principles Workshop The Training Team Dr Bob McDowall, Workshop Director, McDowall Consulting, UK Dr Lajos Hajdu, Senior Validation Engineer, AstraZeneca, Sweden Richard Thomas, CSV Consultant, CTG, UK Victoria Lander, Compliance Development Manager, Waters Technologies, USA In the highly regulated environment of the healthcare industries ALL software automating regulated processes must be validated. The major approach to validation is found in the Good Automated Manufacturing Practice (GAMP) guidelines. GAMP, however, only provides a framework but does NOT provide enough detail! Although GAMP has been referenced by the FDA, it is not the magic bullet for validation of software applications. Moreover, what about the costs of validating all of this software? What should you validate and how should you validate? What can you ignore? How do you defend your position in front of an Inspector? This workshop is uniquely structured to have presentations of the core essential validation principles followed by parallel GMP, GLP and GCP workshops where these will be reinforced for the attendees in their own regulatory discipline. FREE BOOK! Every Attendee will receive a FREE copy of Dr Bob McDowall s NEW book Validation of Chromatography Data Systems published by the Royal Society of Chemistry (RSC). Waters Corporation - No other company can offer a more comprehensive range of system solutions, products and services like Waters. Liquid Chromatography. Mass Spectrometry. Informatics. Columns and Chemistries. Services and Support. From sample preparation, throughput, efficiency, sensitivity and quantitation issues, to uptime, compliance, maintenance and support concerns. Whatever your laboratory s needs, Waters provides complete confidence in the technologies you need, when you need them. For more information, visit The 21CFRPart11.com web site provides access to information on the rule and also maintains an list that actively discusses issues and concerns with industry peers and government regulators. On this site you will find the latest conference, meeting and seminar information as well as links to vendors and consultants who can help the pharmaceutical community with issues of compliance with regulations and productivity. LCGC Europe is the premier business-to-business publication serving the separation science industry in Europe. Published monthly, LCGC Europe is a leading supplier of troubleshooting information and application solutions on all aspects of sample preparation, chromatography, capillary electrophoresis, hyphenated systems, and associated data handling and quality issues. Quality Assurance Journal - An international forum for Quality Assurance Professionals in the pharmaceutical, health and environmental industries, and promotes excellence in practice in these fields. Articles cover compliance with and interpretation of codes of conduct such as GCP, GLP and GMP and other regulations and guidelines; education, training, certification and accreditation; and general quality management and measurement. Computer Weekly is the UK s leading publication for IT decision makers in end-user companies. Its award winning editorial team consistently delivers news and analysis on the topics that matter - from the latest technical developments to winning management strategies. That s why Computer Weekly consistently comes out top in independent readership research and was named PPA Business Magazine of the Year 2000 and Campaigning Magazine of the Year in 2001, 2002, 2004 and Scientific Computing World is Europe s only magazine dedicated to the computing and information needs of professional scientists and engineers. In contrast to North American magazines with European editions that tend to have a US-centric view of the world, Scientific Computing World is written by European experts to meet the information requirements of an influential and loyal European audience. Published 6 times per year since 1994, this highly respected magazine continues to reflect the rapidly changing landscape of computing for science and engineering. Visit our website:

5 Registration form Reducing Time, Costs and Risks Involved in Software Validation Thursday, 1 st and Friday, 2 nd December st Delegate Details 2nd Delegate Details 3rd Delegate Details Name of Firm/Organisation Address M0561 Friday, 1 st & Thursday, 2 nd December 2005 Venue: Hilton Olympia, London, UK 380 Kensington High Street London, UK, W14 8NL Tel: ; Fax: Group Bookings: Book three or more people on the SAME course(s) at the SAME time and receive a further 10% discount off the quoted price. This also applies for early bird discounts if you book before 7th October Discounts on large group bookings are also available. Please contact for more details. Registration: Post: Complete and return the registration form together with payment to: The Registration Manager Regulatory Compliance Workshop Group PO Box London NW6 7XQ, UK Fax: Complete and send the registration form to: +44 (0) Telephone: For provisional and confirmation bookings please phone: +44 (0) Please remember to quote the reference code, title and date For provisional bookings please send an to info@rcwg.org Internet: Visit our webiste and provisionally book online at A CONFIRMATION OF YOUR REGISTRATION WILL BE ED TO YOU. PLEASE ALLOW ONE WEEK FOR CONFIRMATION. IF YOU HAVEN'T RECEIVED CONFIRMATION AFTER THIS TIME PLEASE CONTACT US. Telephone Fax Postcode Accommodation: have arranged a special room rate for this event of 119 plus VAT inclusive of breakfast for a single room and plus VAT inclusive of breakfast for a double room. For room reservations please call +44 (0) Alternatively, please look out for special rates by booking online at Signature Payment Details The price includes: Attendance at the 2-day workshop Continental breakfast, coffee breaks, lunch and all refreshments Evening Networking Drinks Reception at the end of Day 1 Course documentation and CD ROM Certificate of Attendance FREE BOOK from Royal Society of Chemistry titled Validation of CDS (worth 80) Government/Academia / 599 ( / including VAT) Booking after 7th October / 1199 ( / including VAT) Early Bird Discount (Book on or before 7th October) / 1099 ( / including VAT) Cheque Enclosed Please Invoice Me Credit Card Cheque payment: All cheques to be made payable to Card No. Expiry Date / Signature Account Name Account Address (if different from above) Documentation & CD ROM I am unable to attend this conference. Please send me Delegate Resource Pack(s) and accompanying CD ROM at 299 each including postage and packaging. Please note: Rescource Pack and CD ROM will be sent out after the event Sponsorship: Would you like to make most of this business opportunity and network with your target audience? If so, please at info@rcwg.org or call us on +44 (0) Cancellation Policies: You must confirm your CANCELLATION in writing two weeks before the date of the course and receive a refund less 10% administration fee. Regrettably no, refunds can be made for cancellations received less than one week prior to the conference. However, substitutions are allowed and conference documentation will be sent to the cancelled persons. Data Protection: Personal data is collected in accordance with the Data Protection Act Your details may be passed to other companies who may wish to communicate with you. Please tick the box if you do not want your details used in this way. Incorrect or Multiple Mailing: If you are receiving incorrect mailings or multiple mailings or would like us to update your details please info@rcwg.org to have this corrected. Our sincere apologies for any inconvenience this may cause. Additional Requirements: Please notify the Regulatory Compliance Workshop Group at least one month in advance if you have any additional requirements. PLEASE NOTE: All credit card transactions will be processed through our UK Headquarters. The amount in Sterling indicated in the Payment Details section will be charged to your credit card. The market exchange rate for Euros will be used at that time. If the amount taken from your credit card exceeds the specified amount the difference will be refunded. If the amount is less than the specified amount no further funds will be credited from your credit card. If you have any queries, please do not hesitate to contact us. VAT Registered No