Ms. Ann-Kristin Gellerbring Senior Scientist Regulatory GE Healthcare

Ann-Kristin Gellerbring has more than 18 years experience from biopharmaceutical development from Pharmacia & Upjohn in different management roles, including development of products from plasma, heparins and recombinant proteins. She has for 9 years led a team within GE Healthcare, providing education and validation support to customers in the biopharmaceutical industry. In her current role within R&D, she is responsible for regulatory compliance issues related to development of platform processes for vaccines, MAbs and plasma within enterprise solutions offerings.

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Dr. Katja Aschermann, Dipl. Biol. Key Account Manager Protein Services Head of Quality Management

Katja studied Biology at Heinrich Heine University Dusseldorf, Germany, and received her PhD in 2001. After a post-doctoral study in Natural Sciences, she worked at Newlab BioQuality AG (today part of Charles River Lab Inc.) for two years. She joined Protagen AG in 2005.

Since then she has successfully setup a risk based Quality Management System and is responsible for Protagen GMP certification by the regulatory body. For our international clients she is also active as project manager in QM and consultancy. Among these projects she has developed a Risk Based QM concept and applied it for product comparability studies.

Katja now works as key account manager for protein services with a main focus on biopharmaceutical companies and is responsible for the entire sales team.

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Dr. Martin Wisher Scientific Director BioReliance

Dr. Martin Wisher has more than 23 years experience in biosafety testing and validation. He has worked for BioReliance, UK, since the company was founded in Stirling in 1990, acting as Scientific Director since 1993. He has extensive experience in the technical, scientific, quality and regulatory aspects of the services offered by BioReliance and provides consultancy in these areas to both clients and internal departments.

Prior to joining BioReliance, Dr Wisher worked for Inveresk Research as Manager of Immunology, responsible for biosafety services. He obtained a PhD in membrane biochemistry from the National Institute for Medical Research, London, and prior to moving to the contract research industry was involved in research on membrane receptors, monoclonal antibodies and recombinant vaccines.

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Dr. Sarah Sheridan Scientific Director BioReliance

Sarah Sheridan (ne้ Sarah Gilliam) is a Scientific Director at BioReliance UK with responsibilities aligned with the in vivo and veterinary vaccine testing services. Sarah has been with the company for 13 years and has a total of 15 years experience within the biotech industry including animal and human health. Sarah directed the BioReliance in vivo testing division for over 6 years and established the BioReliance veterinary vaccine safety testing division. She has extensive experience in pre-clinical in vivo and in vitro safety evaluation of biopharmaceuticals including in vivo and in vitro assay development, gene distribution and potency studies, cell bank characterisation and extraneous virus detection. In her current role as Scientific Director, Sarah is involved with business development, internal and external scientific and regulatory support and assay harmonisation. Sarah is also the Biological Safety Officer for BioReliance UK. Sarah is a graduate of the University of Cambridge, with a PhD in Veterinary Science.

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Mr. Ali Ismail Technology Sales Specialist BioReliance

Mr. Ismail is a Technology Sales Specialist at BioReliance, covering the Scandinavian and the Middle East-North African (MENA) territories. Ali Ismail manages all accounts from a Sweden based office. He has worked with BioReliance since March 2008.

Prior to Bioreliance, he worked for BioInvent International AB as Senior Process Engineer for ten years, within the Purification Department, with extensive experience in the downstream process development and viral clearance. During his years at BioInvent, Ali joined many working teams as facility and maintenance, equipment design and validation and staff safety. Ali participated also in many research projects in collaboration with Lunds University in Sweden.

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Dr. Mats Lundgran Vaccine R&D Director GE Healthcare Life Sciences

Dr. Lundgren, is the Vaccine R&D Director at GE Healthcare Life Sciences. He holds a PhD in Immunology, Cell and Molecular Biology from the Karolinska Institute, and extensive post-doc training at the MRC Clinical Sciences Centre, Imperial College School of Medicine in London, UK. In his industrial career Mats has had positions as scientist, team manager and VP at Pharmacia, AstraZeneca and other biotech companies in Sweden, managing Cell line and Upstream Process Development teams recently. In his current role as Vaccine R&D Director, Dr. Lundgren works across the different vaccine application projects, focusing on applicability of new vaccine technologies and manufacturing solutions.

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Dr. Roland Kotzian Pall Life Sciences

Dr. Roland Kotzian is the European Project Manager in the Pall Advanced Separation System (PASS) Team. The group is responsible for the delivery of separation and purification equipment and services. This includes all aspects of Project Management and Process Engineering covering the entire project life cycle starting from Project/Process evaluation all the way to System and Process Qualification.

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Mr. Massimo Golia Pall Life Sciences

Mr. Golia has over 25 years experience in activities related to Pharmaceutical Industry. 20 years ago he joined Pall Italia, branch of Pall Corporation. Currently he is responsible for Marketing in Biopharmaceutical Division. This position allows to him to be in contact with the newest evolution of technologies and regulations concerning filtration, separation and purification applications. He has published articles on the most important Italian Pharmaceutical magazines and he is used to present lectures to pharmaceutical manufacturer associations and universities. Massimo played an active role in Italian Chapter of Ispe, being in charge as responsabile of Vendor Committee. Recently Massimo was directly involved in drawing up the new edition of ”Manufacturing Process Validation: Sterile Forms”, Technical Manual of AFI (Italian Pharmaceutical Industry Association). Frequently he holds lectures in international PDA Conferences. On an European level he represents Pall Life Sciences in the working party of ECI (Eye care Industry) Interest Group.

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Mr. Steven A. Weitzel VP, Technical Validation Operations

Mr. Weitzel is a recognized expert on cleaning and contamination control for drug and medical device manufacturing. Current responsibilities include technical support, and quality systems for CANI, Inc. process cleaning agents marketed through VWR International. The company offers a full range of technical and validation services related to cleaning and microbial control. In addition, he directs process development, regulatory compliance and validation, and technical applications development for the revolutionary 2-phase Novaflux cleaning technology. This includes low temperature sterilization, water systems decontamination, disinfection and cleaning of purification membranes, endoscopes, hemodialyzers and bioprocess equipment, and direct surface analyzers. He earned a B.S. in chemical engineering from the University of Missouri, and a Masters in Business Administration from Washington University in St. Louis. He has over 20 years experience in FDA regulated industry in, engineering, operations, validation and technical marketing at Dow Chemical, Mallinckrodt, and divisions of Merck and Bristol-Myers Squibb. He has conducted technical training or consulted for the world's leading pharmaceutical, biotech and medical device companies and made numerous technical presentations on the topics of process validation and change control, contamination control, aseptic manufacturing, microbial control and monitoring, critical cleaning and cleaning validation. He is a member of the PDA and ISPE.

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Dr. Teri Stokes Computerized System Specialist GXP International

Dr. Teri Stokes is an International Consultant on the topic of computer systems validation to the pharmaceutical, biotech, and health care industries and their system suppliers. Her special focus is the development of corporate policy and its practical implementation through to project level activities across international sites for systems operating under regulations for GLP, GCP, GMP, and Electronic Records. Successful engagements have been delivered for clients in North America, Europe, and Japan.

Dr. Stokes established her own consulting firm GXP International in March 1996 after more than 16 years with Digital Equipment Corporation where her last assignment was as Director of Computer Validation Services in the Americas. From May 1990 to June 1995, she worked for Digital in Basel, Switzerland and established Digital’s validation services business in Europe. During 1993-95, Dr. Stokes served as a Founding Member on the Board of Directors of the European Forum for Good Clinical Practice (EFGCP) in Brussels, Belgium and participated in the Audit Working Group of the EFGCP.

Prior to coming to Digital in 1979, Dr. Stokes had a 12 year management career in hospital and commercial medical laboratories in the USA. Her introduction to computers came within a GLP environment where laboratory testing for 2,000 patients per day was performed. The computer systems for this laboratory also transmitted report results to 21 remote sites.

In her 16+ years at Digital, Dr. Stokes kept a focus on the pharmaceutical, biotech, and chemical industries across her various assignments. She holds a B.A. degree in Biology from Boston University and a professional registration as a Medical Technologist, M.T.(ASCP). Dr. Stokes received her M.S. degree in Management in 1987 from Lesley University with a marketing thesis on Remote Data Entry in Clinical Trials: Technology & Market Readiness. In 1991 she received her Ph.D. in Management from Walden University with a Dissertation titled “Clinical Data Management Trends: New Technologies and EC 1992.”

Program Agenda

Day 1 - Sunday, February 21, 2010
8:30 AM. – 1:00 PM	Registration
9:30 AM – 10:00 AM	Welcome note by Dr. Ayman Sahli, the General Manager of Julphar Gulf Pharmaceutical Industries Message by Ministry of Health, U.A.E Thanking the collaborators of 4th cGMP Update 2010
10:00 AM – 10:15 AM	Morning Tea Break
10:15 AM - 12:00 AM	Quality Control for Biologics - Testing for adventitious agents in cell lines and raw materials
	Dr. Martin Wisher Bioreliance
12:00 AM - 2:00 PM	Quality Control for Biologics – retrovirus detection and oncogenic agents, including considerations for novel cell substrates
	Dr. Sarah Sheridan Bioreliance
2:00 PM - 3:15 PM	Lunch Break
3:15 PM - 4:15 PM	Microbial Cell Line Characterization
	Dr. Martin Wisher Bioreliance
4:15 PM - 4:30 PM	Afternoon coffee break
4:30 PM - 5:30 PM	Planning and Conducting Viral Clearance Studies: An Overview
	Mr. Ali Ismail Bioreliance
5:30 PM - 6:00 PM	Q&A Session
	Dr. Martin Wisher & Dr. Sarah Sheridan
6:00 PM	Conclusion of Day One
Day 2 - Monday, February 22, 2010
9:00 AM - 11:00 AM	Validation Aspects in Development & Manufacturing of Biopharmaceuticals
	Ms. Ann-Kristin Gellerbring GE Healthcare
11:00 AM - 11:15 AM	Mid-Morning Refreshment Break
11:15 AM - 12:15 AM	Development and Manufacturing of Biopharmaceuticals
	Dr. Mats Lundgran GE Healthcare
12:15 PM - 2:00 PM	Biotech Process - Overview of the Filtration and Separation technologies
	Dr. Roland Kotzian Pall Life Sciences Mr. Massimo Golia Pall Life Sciences Pall Life Sciences is specialized in filtration, separation and purification technologies such as dead-end filtration, tangential flow filtration or chromatography. Products are used from the earliest stages of discovery and development of drugs, through production and delivery of therapies for the prevention, diagnosis and treatment of disease. Those technologies are part of any Biotechnological process and the scope of the presentation is to describe those applications from the fermentation to the cell harvesting and from the downstream processing to the final filling. First with the main technical and regulatory aspects highlighting the new media and media configurations to increase the process yield and its easy handling, the validation requirements, the concept of disposable technology which can also play an important role in a Bioprocess in order to increase its safety. This is an essential aspect of a Biotech process to provide reliable and fully integrated solutions for design, manufacture and servicing of complex engineered systems and package units.
2:00 PM - 3:15 PM	Luncheon
3:15 PM - 5:30 PM	Computer & Software Validation
	Dr. Teri Stokes GXP International Introductions – Who are you and what is your current validation challenge? Interactive Tutorial 01 – Global Regulations and Common Compliance Themes From FDA Blue Book in 1973 to the Present for GMP, GLP, GCP, and 21 CFR Part 11 Interactive Tutorial 02– How to Perform Computer Validation with OQ/IQ/PQ Variations for Supplier, IT, and End User – System Control, Human Control, Testing Control Group Work Case Study #1 - Walk-though Review of the actual Validation Plan, Test Plan, and related summary report documents from a retrospective validation project for an LC/MS laboratory system. Group Discussion of study questions to explore the roles and structure of various computer validation documents
4:15 PM - 4:30 PM	Afternoon Coffee Break
5:30 PM - 6:00 PM	Q&A Session
	Ms. Ann-Kristin Gellerbring, Dr. Mats Lundgran, Dr. Roland Kotzian, Mr. Massimo Golia, and Dr. Teri Stokes
6:00 PM	Conclusion of Day Two
Day 3 - Tuesday, February 23, 2010
9:00 AM - 11:00 AM	Computer & Software Validation (course continue)
	Dr. Teri Stokes GXP International Interactive Tutorial 03 – Formal Testing Practices for Auditable Test Results Roles & Responsibilities for Script Author, Reviewer, Tester, and Witness, Requirements and Trace Matrix, Test Script standard elements, and formal result recording practices Group Work Case Study #2 - Walk-through of actual test scripts, URS, and Ongoing Test Plan from LC/MS validation. Group Discussion of study questions to explore the roles and structure of various test documents.
11:00 AM - 11:15 AM	Morning Tea Break
11:15 AM - 2:15 PM	Design and Management of Environmental Monitoring Program Design
	Mr. Steven A. Weitzel Technical Validation Operations EU GMP Annex 1 and ISO 13408 Requirements for Environmental Monitoring Application of USFDA Guidance on Aseptic Processing Current and Upcoming Changes to Cleanroom Standards Environmental Monitoring Methodologies Non-Viable Monitoring to meet Current Legislative Requirements Selecting Suitable Particle Monitoring Locations Viable monitoring
2:00 PM - 3:15 PM	Luncheon
3:15 PM - 5:30 PM	Design and Management of Environmental Monitoring Program Design (course continued)
	Mr. Steven A. Weitzel Technical Validation Operations Gap Analysis and Risk Analysis for EM sites Implementing an Effective cGMP Cleaning and Sanitization Program Disinfectant Efficacy Evaluations Cleanroom disinfection Protocol for Aseptic Applications Solutions for Addressing Fungal Contamination in Cleanrooms Trending and Analysis of Environmental Monitoring Data Interpretation and Application of Monitoring System Data Key Investigation Points for Environmental Monitoring Excursions Root Cause Analysis and Investigation of EM Excursions
4:15 PM - 4:30 PM	Afternoon Coffee Break
5:30 PM - 6:00 PM	Q&A Session
	Dr. Teri Stokes & Mr. Steven A. Weitzel
6:15 PM	Conclusion of the GMP-UPDATE 2010 Conference
8:30 PM	GALA DINNER

Registration Fee Includes: Presentation Materials, Luncheon, and Refreshments

Cancellation/Substitutions Policy: CANCELLATION POLICY: Cancellation is accepted in writing (by mail, or fax) up to 4 weeks before the program start date, after which cancellations are not accepted and do not qualify for refund or credit. All Cancellations are subject to a USD $250.00 person processing fee. Substitution of delegate/s with the member/s of the same organization is permitted at any time. IPA reserves the right to postpone an event, prior to which time all the registered attendees will be notified a minimum of 2 weeks in advance. IPA shall not be responsible for any air fare, hotel or transportation costs incurred by registrant/s.

Conference Exhibition

IPA offers the opportunity to present your company, your products and services to your target audience by means of a Conference Exhibition.

By exhibiting and /or sponsoring at Dubai’s GMP 2010 – Update you'll be able to:

• Meet and identify new prospective clients
• Connect and build upon existing clients
• Gain promotional value  and broadening your visibility
• Receive highly-qualified leads

The Costs USD $2,000.00 (for 2 days, February 22nd – 23rd, 2010)

The Exhibition Fee includes:

• The list of attendees
• 6’x2’ skirted table
• Two full conference pass
• If you register early, your firm will be listed in the event program
• Lunch and refreshments for 2 people for 2 days
• Personal support on site

This conference will be of critical interest to companies and individuals involved in the starting materials, API and medicinal products business, particularly those affected by GMP interpretation and regulatory inspections: Inspection/Audit, Validation, pharmaceutical R&D, Regulatory Affairs, Manufacturing, Quality Assurance/Quality Control, Compliance, and Qualified Person.

Dear friends & Colleagues,

The International Pharmaceutical Academy (IPA) would like to extend an invitation to pharmaceutical and biotechnology scientists and technologists from throughout the world to join us at Dubai’s upcoming fourth “GMP-Update 2010” conference and exhibition that will be held from February 21-23, 2010 at the Grand Hyatt Hotel in Dubai, United Arab Emirates under the auspices of the Julphar Pharmaceutical.

For the last four years Dubai’s GMP-Update Forum has been the preeminent conference for pharmaceutical, biotech and device compliance professionals focusing on the full spectrum of topics which are of universal interest and addresses the implications of what the current key GMP requirements are, and how are they changing, or interpreted by various regulatory agencies.

February 2010 is fast approaching and we invite all professionals of the global pharmaceutical and biotech communities, and regulatory agencies to mark these dates and make every effort to join us in Dubai, one of the world's most sought after meeting and tourist destinations.

The quality and diversity of this year’s event is mainly due to coalition of senior technical and compliance experts from pharmaceutical, and life sciences sectors addressing several hot topics that are particularly important to your day-to-day professional function including:

• Quality Control for biologics
• Planning and conducting Viral Clearance studies
• Regulatory aspects in biotechnological manufacturing
• Development and manufacturing of biopharmaceuticals
• Filtration and Separation technologies
• Computer & Software Validation
• Design and Management of  Environmental Monitoring Program Design

We anticipate that 150 - 250 delegates will attend this 2010 conference. This conference will provide attendees with a tremendous opportunity to network with fellow colleagues, industry experts, and key vendors of equipment and supplies. Lunches and refreshment breaks will provide a relaxed opportunity to discuss the issues raised during the day’s presentations and allow time for visiting with vendors.

See you February 21-23, 2010 in Dubai for this unique and interactive learning opportunity!

Yours sincerely

Dr. M. Barghian