M2 Presswire , 09/09/2003
Advanced Computer Systems Validation For Pharmaceutical, Biotech & Medical Device Companies 17th & 18th November 2003, The Hatton, London -- Supported by: ABB Eutech -- Visit us at http://www.smi-online.co.uk/csvadvanced8.asp.
COPYRIGHT 2003 Ingram Investment Ltd.
M2 PRESSWIRE-9 September 2003-SMI: Advanced Computer Systems Validation For Pharmaceutical, Biotech & Medical Device Companies 17th & 18th November 2003, The Hatton, London -- Supported by: ABB Eutech -- Visit us at http://www.smi-online.co.uk/csvadvanced8.asp(C)1994-2003 M2 COMMUNICATIONS LTD RDATE:09092003
PLUS A HALF-DAY POST-CONFERENCE EXECUTIVE BRIEFING Documentation Requirements for CSV - The 'How-To's' of Computer System Validation Documentation 19th November 2003, The Hatton, London
PLUS A FULL-DAY POST-CONFERENCE EXECUTIVE BRIEFING Technical Aspects of Implementing 21 CFR Part 11 19th November 2003, The Hatton, London In association with Systonomy
This Conference will provide a forum for validation professionals to hear about the technical implementation of legislation governing the validation of computer systems. It will provide the very latest update on 21 CFR Part 11, GAMP regulations and compliance issues, including audit trends, common pitfalls and an evaluation of FDA warning letters. It will also look at the tools and concepts of Six Sigma.
SMi would also like to draw your attention to our corresponding event: Computer Systems Validation: Key focus: Laboratory Computer Systems - For Pharmaceutical, Biotech and Medical Device Companies, being held on 22nd & 23rd September 2003.
This essential meeting will help you:
* UNDERSTAND technical aspects of complying with processes and procedures
* OPTIMISE system prioritisation - GAP analysis & Part 11 assessment
* MAXIMISE benefits of legacy systems validation
* MITIGATE enforcement actions in the event your organisation is cited for process control deficiencies
* EVALUATE the new FDA Warning Letter review process
* ASSESS the latest inspection and enforcement practices
* LEARN about the risk-based approach to Part 11 compliance
* DISCOVER the process and benefits of using Six Sigma for computerised systems validation
Gain an insight from the key industry experts in the field:
* KLAUS KRAUSE, Corporate Manager, Computer Systems Compliance, AMGEN
* RON ARMSTRONG, Manager, R&D QA, Computer Systems Compliance, BOEHRINGER INGELHEIM
* MICHAEL BRITT, Site Manager, Systems Validation Services, ROCHE
* DR ROBERT STEPHENSON, Regulatory Systems Team Leader, PGMIT, PFIZER
* DR LUDWIG HUBER, Product Marketing Manager, AGILENT TECHNOLOGIES
* Dr TERI STOKES, Director, GXP International
* KATE SAMWAYS, Director, KAS Associates & Secretary, EUROPEAN STEERING COMMITTEE (GAMP)
* RON JOHNSON, Executive Vice President, QUINTILES (FORMERLY FDA)
* CAROLYN STOCKDALE, Manager, Quality & Regulatory Compliance - Validation, PHASE FORWARD
The SMi Group is a world leader in business to business information with products spanning over 250 countries - within the past year over 30,000 senior executives from blue chip companies have benefited from SMi's highly targeted conferences, executive briefings, newsletters and management reports.
Website: http://www.smi-online.co.uk/csvadvanced8.asp
Katy West Marketing Department SMi Conferences Ltd Tel: +44 (0) 20 7827 6108 Fax: +44 (0) 20 7827 6109 Email: mailto:kwest@smi-online.co.uk
Please scroll down to view the full Conference programme.
Day One - 17th November 2003
8.30 Registration & Coffee
9.00 Chairperson's Opening Remarks Dr Teri Stokes, Director, GXP International
KEYNOTE ADDRESS: CSV MODELS 9.10 IQ, QQ, PQ in computer validation - the who, what and why
* Who does what in CSV and why?
* What is computerised system validation (CSV) about?
* Why have three types of qualification?
* How is a validation plan different from a test plan?
* What is the real reason for using summary reports? Dr Teri Stokes, Director, GXP International
GOVERNING PROCESSES AND PROCEDURES FOR CSV 9.40 Creating useful tools for compliance
* Corporate and global procedures
* Local procedures
* Practical SOPs
* Change control
* Fitting the needs of the business Ron Armstrong, Manager, R&D QA, Computer Systems Compliance, Boehringer Ingelheim
TECHNICAL ASPECTS OF COMPLYING WITH PROCESSES AND PROCEDURES 10.20 Taking the pain out of computer systems validation training and communication
* Auditing against procedures
* Documenting variances and justifications for deviations
* Procedures for systems involving equipment and databases Judi Boyle, Associate Director, R&D QA, External GMP & Part 11 Computer Compliance, Boehringer Ingelheim
11.00 Morning Coffee
TYPICAL DOCUMENTATION REQUIREMENTS FOR CSV 11.20 Overview of computer system validation methodologies
* General validation concepts and definitions
* Governing processes and procedures - The FAQs of documentation requirements
* Why is documentation required?
* Who is responsible for documentation?
* What should be documented?
* How should we prepare documentation? Carolyn Stockdale, Manager, Quality & Regulatory Compliance - Validation, Phase Forward
NEW REGULATIONS AND GUIDANCE FOR COMPUTER SYSTEMS 12.00 Computer validation and E-records/signatures
* EU regulations and guidelines, eg PIC/S
* FDA's current thinking and implementation of part 11
* Inspection and enforcement practices
* Recent Warning Letters
* Impact of risk-based system inspections
* New focus: IT infrastructure and networked systems
* Recommendations from the industry Dr Ludwig Huber, Product Marketing Manager, Agilent Technologies
12.40 Networking Lunch
COMPLIANCE WITH 21 CFR PART 11 2.00 Issues and enforcement strategy - what is the FDA really looking for?
* Clear at last? - FDA's latest guidance on Part 11
* A risk-based approach to Part 11 compliance
* Part 11 - business as usual? Dr Robert Stephenson, Regulatory Systems Team Leader, PGMIT, Pfizer
RISK BASED PART 11 COMPLIANCE STRATEGIES 2.40 Developing a rigorous and systematic approach for cGMP automated systems
* Scope of Part 11 and the current FDA thinking
* Predicate rules - the new essence
* New & legacy systems - what is FDA saying?
* Risk-based approach - the central point
* GAP analysis & Part 11 assessment - system prioritisation
* Compliance strategy - a practical approach Dr Rachita Sharma, President, FDA Computer Validation (contracting for Bayer & Baxter)
3.20 Afternoon Tea
IS 21 CFR 11 STILL THE GOLD STANDARD? 3.40 Outlook in an uncertain future
* Traditional position of FDA as 'strictest' regulator
* Strengthening European regulatory framework
* Changes in FDA guidance and enforcement
* Trends in European regulatory enforcement
* Role of externally published good practice John Farrell, Principal Consultant, The Synapse Partnership
LEGACY SYSTEMS 4.20 Bringing existing systems into compliance
* Understanding the legacy system problem
* Establishing a programme for legacy system validation
* Benefits of doing legacy systems validation
* Defending legacy systems during inspections Kate Samways, Director, KAS Associates & Secretary, European Steering Committee, (GAMP)
5.00 Chairperson's Closing Remarks and Close of Day One
Day Two - 18th November 2003
8.30 Re-registration & Coffee
9.00 Chairman's Opening Remarks John Farrell, Principal Consultant, The Synapse Partnership
THE LATEST FDA GUIDANCE REVIEW ON PART 11 AND PROCEDURAL CHECKLISTS 9.10 What is the FDA looking for in an inspection?
* History of guidance document
* FDA intention vs industry reaction
* Pure vs hybrid systems
* Current validation practices
* Audit trail - the most confused topic
* Archival, copies of records & record retention
* Procedural vs technical controls
* A checklist for Part 11 success
* Current FDA inspection trends Dr Bhanu Sharma, Manager, Computer Systems Validation & Compliance for a leading Pharmaceutical company
THE FDA-483 AND THE WARNING LETTER 9.40 How to handle 483 observations
* What is FDA's foreign inspection programme?
* Can you get a Warning Letter even if you did not get a 483?
* If no 483 is issued, should you respond to observations in the EIR?
* Who writes FDA Warning Letters?
* Can you avoid getting a Warning Letter?
* What does the new FDA Warning Letter review process mean to you?
* What regulatory action can result following a Warning Letter?
* How does a Warning Letter affect a foreign company?
* What can you do if FDA puts you on import alert? Ron Johnson, Executive Vice President, Quintiles (formerly FDA)
GAMP 10.20 A framework for risk based validation
* Influence of different risks on your computer validation programme
* When and how to evaluate risk throughout the life cycle
* Expectations for validation of different types of application (eg LIMS, custom development, spreadsheets)
* Using GAMP to validate your computerised system Chris Reid, Director & Principal Consultant, Integrity Solutions & Member, European Steering Committee, GAMP
11.00 Morning Coffee
APPLICABILITY OF SOPS TO IT DEPARTMENTS 11.20 What does it mean to them?
* What is achieved by SOPs?
* What are they written for?
* How does this affect the IT team?
* Existing technical activities are performed accordingly David Stephenson, Consultant, ABB Eutech (formerly GlaxoSmithKline)
QUALIFICATION OF NETWORK INFRASTRUCTURE AND SYSTEMS VALIDATION 12.00 Critical considerations
* Definitions - the 4 Qs
* How does infrastructure align with the business model?
* The elements of infrastructure
* Qualification vs validation
* Steps to qualification of infrastructure
* Supporting your customers/users validation needs Michael Britt, Site Manager, Systems Validation Services, Roche
12.40 Networking Lunch
SECURING YOUR NETWORK 2.00 Is your data really safe? Find out how to protect it
* Who owns the network? - get it under control
* Remember 85% of attacks are from inside your company
* Secure GXP data with at least a router and firewall
* Use all the security features of the operating system
* Explain very clearly to staff the reasons for network security and then act on security breaches
* Data is the beginning of corporate intellectual property - guard it well Bob Taylor, Technical Director, Smart Tech Worldwide (formerly GlaxoSmithKline)
QUALITY MANAGEMENT SYSTEM FOR COMPUTER SYSTEMS COMPLIANCE 2.40 Achieve and maintain compliance
* System structure
* Components and controls
* Global computer system registry as a quality management tool Klaus Krause, Corporate Manager, Computer Systems Compliance, Amgen
3.20 Afternoon Tea
EFFECTIVE GAP ANALYSIS AS A TOOL FOR COMPLIANCE 3.40 How to fit GAP analysis into compliance initiatives
* Effective GAP analysis techniques
* Preparing for a GAP analysis: developing worksheets and checklists
* Conducting a computer systems GAP analysis
* Conducting a 21 CFR Part 11 GAP analysis
* Risk analysis techniques
* Practical and impractical corrective methods
* How to mitigate enforcement actions in the event your organisation is cited for deficiencies Dr Jennifer Methfessel, Senior Consultant, Life Sciences, ABB Eutech
TOOLS AND CONCEPTS OF SIX SIGMA 4.20 The process and benefits using Six Sigma for computerised systems validation
* The economics of computerised systems compliance and validation
* How Six Sigma and software process improvement fit into quality regulation systems
* What Six Sigma tools are usable in computerised system validation and how process improvement methodologies operate
* The use of measurement to prove objective success and achievement
* Challenges for deploying such initiatives within software/IT communities Dr Radouane Oudrhiri, Chief Technology Officer, Systonomy
5.00 Chairman's Closing Remarks and Close of Conference
CONTACT: Katy West, Marketing Department, SMi Conferences LtdTel: +44 (0)20 7827 6108Fax: +44 (0)20 7827 6109e-mail: kwest@smi-online.co.uk
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