Distinguished Faculty

Jerry Anderson, Director, Corporate

Quality Computer Systems, Watson
Pharmaceuticals
Steven Bende, Ph.D., Vice President,
Science and Regulatory Affairs, Generic
Pharmaceutical Association (invited)
James Duckworth, eRecordManager
Product Manager, Thermo Electron
IBC’s Inaugural Conference on
James Green, Ph.D., Vice President of
Pre-Clinical and Clinical Development,
Biogen, Inc.
Kenneth Hughes, Ph.D., Vice President
of Scientific Affairs, Microbix
Biosystems, Inc.
Dianne Jackson-Matthews, Ph.D.,
Director of Regulatory Affairs, ERA
21 CFR Part 11
Consulting Group
Alan Jakimo, Partner, Sidley, Austin,
Ensuring Compliance to Prevent Citations and
Brown and Wood
Michael A. Kolba, Senior Director of
Manufacturing Interruptions
Validation Operations, Aker Kvaerner
Pharmaceuticals
Victoria V. Lander, Market Development February 23-24, 2004
Manager, NuGenesis Technologies
Massoud Lavian, Senior Consultant and Sheraton San Diego Hotel & Marina
Project Manager, Clarkston Consulting
San Diego, CA
Andrea Loewen-Rodriguez, Ph.D.,
Associate Director, Regulatory Affairs,
IDEC Pharmaceuticals
Scientific Advisors:
Kevin C. Martin, Director, Sales &
Marketing, CimQuest, Inc. USA Massoud Lavian, Clarkston Consulting
Christopher McElroy, Manager, Wolfgang Winter, Agilent Technologies, Germany
Part 11 Program Management Office,
Wyeth Pharmaceuticals
Gregory Meyer, RAC, CQA, President Post-Conference Symposium
and Principal Consultant, Compliance
Media and Acting Director of Comparability Protocols for Biologicals:
Compliance, Connetics Corporation
Strategies for Post-Approval Changes
Jeanne Novak, Ph.D., President and
Principal Consultant, CBR International
Rhona O’Leary, Ph.D., Senior Scientist,
Recovery Sciences, Genentech, Inc. “This conference is a key information resource and provides thorough insight of
Larry Puderbach, Senior Director, Part 11 current regulations and guidance from both a regulatory and industry
Compliance, Wyeth Pharmaceuticals perspective. Industry experts share real world examples and best practices for
Chris Schreil, Senior Manager of successful risk-based compliance strategies and implementation.”
Automation Engineering, Projects and
Infrastructure, Genentech, Inc. -Wolfgang Winter, Agilent Technologies
George J. Serafin, President, The Serafin
Group, LLC
Charlie Sodano, Ph.D., Manager Media Partners:
Information Services, Berlex Biosciences
Gail Sofer, M.S., Director of Regulatory
Services, BioReliance
Terry L. Stinger, Computer Systems
Auditor, Corporate Quality Assurance -
Computer Systems, Eli Lilly and
Company
Steve Swanson, Ph.D., Director of Clinical
Immunology, Amgen, Inc.
Wolfgang Winter, Senior Product
Manager, Agilent Technologies,
Germany
Elien Young, E-Compliance Manager,
Life Sciences www.LifeSciencesInfo.com
Novartis Part of Informa Life Sciences Group - The leading provider of scientific, technological and business information
 21 CFR Part 11 is here to stay and is being enforced by the
FDA investigations. Gain specific risk-based strategies from
leading industry experts to protect your company
from compliance violations.

W
ith the FDA re-issuing their 21 CFR Part 11 guidance, IBC has developed this inaugural conference on 21
CFR Part 11: Ensuring Compliance and Mitigating Risk to offer a timely forum for discussing the
development and implementation of risk-based solution plans. Attend to gain the information you need
to move forward with your Part 11 plan implementation. This is a can’t miss event for individuals charged with
Part 11 compliance, computer and systems validation, information services, quality assurance, regulatory affairs
and process development.
Program highlights include:
• Presentations from leading pharmaceutical and biotechnology companies, including Aker Kvaerner
Pharmaceuticals, Wyeth Pharmaceuticals, Genentech, Novartis, Berlex Biosciences, Watson
Pharmaceuticals, Eli Lilly and Company
• A review of Part 11 and how a commercially viable plan can be created that ensure compliance and
protects public health
• How risk assessment and other proactive strategies can be used to develop a strategic plan for compliance
• Genentech’s challenges in moving their Vacaville, CA plant to a paperless system
• Security issues that need to be addressed to protect data integrity when working in a paperless system
• Computer validation that needs to take place to meet FDA expectations and how legacy systems can
effect compliance
Make the most of your time in San Diego – take advantage of a special post-conference mini-symposium to hear
important updates on comparability protocols. Registrants of Comparability Protocols for Biologicals will hear
the latest strategies for meeting FDA expectations for comparability, as well as the expectations of European
regulators. Learn from a Genentech case study how they successfully approached post-approval changes.
This session will also include a special roundtable discussion on the regulatory pathway that is being carved out
for the approval of biogenerics.
vents
Co-Located E
IBC’s inaugural conference on 21 CFR Part 11 is conveniently timed concurrently with IBC’s 6th International
Conference on Process Validation for Biologicals and will be held right before IBC’s 12th International
Conference on Antibody Production and Downstream Processing. Join attendees of the Process Validation
conference for a shared symposium on Tuesday afternoon on Comparability Protocols for Biologicals. Make
the most of this unique week of informative events and send a team of attendees from your company at a special
rate – Register 3 and the 4th goes FREE! (see registration page for details). For more information on these
events, visit: www.LifeSciencesInfo.com.

Please review the agenda today and register early. Space is limited!
For detailed abstracts, up-to-date information on this event and to register online visit:
www.LifeSciencesInfo.com/Part11

www.LifeSciencesInfo.com/Part11
For detailed abstracts and up-to-date information on this event
Monday, February 23, 2004
8:00 Registration, Coffee and Breakfast Pastries

9:00 Chairperson’s Opening Remarks

Wolfgang Winter, Senior Product Manager, Agilent Technologies, Germany

Developing a Risk-Based 21 CFR Part 11 Strategy

9:10 Part 11 - Where Have We Been and Where Are We Headed?
Alan Jakimo, Partner, Sidley, Austin, Brown and Wood
Thoughts about using electronic records and signatures to comply with FDA regulations date back to the 1991 formation of the FDA
Electronic Identification/Signature Working Group. By 1992, the FDA had published its advance notice of proposed rulemaking on this
subject, leading to adoption of Part 11 in 1997. Compliance, however, remained elusive and expensive, prompting the FDA’s February 2003
announcement of its “embarking on a re-examination of Part 11.” What are the contours of this re-examination and how can the various
stakeholders create a commercially reasonable structure that is consistent with protecting the public health?

9:40 The Role of Standardized Formats in Long Term Data Management (GAML, ANiML, XML)
James Duckworth, eRecordManager Product Manager, Thermo Electron Corporation
Abstract not available at press date. For updates visit: www.LifeSciencesInfo.com/Part11.

10:10 Implementing a Risk-Based Approach to Part 11 Compliance

Christopher McElroy, Manager, Part 11 Program Management Office, Wyeth Pharmaceuticals
FDA established its position that the need for and level of Part 11 controls should be determined using a risk-based approach when it
published its Guidance for Industry; Part 11, Electronic Records; Electronic Signatures - Scope and Application, on February 25, 2003. This
new approach can be applied in a Part 11 program to understand which systems are subject to Part 11, which components of Part 11 should
be implemented, and at what level. This presentation will include an examination of the several risk assessment models that are available to
the industry for reference and an overview of several risk assessment processes. Gaining an understanding of various approaches will provide
insight that may be applied on the job when implementing an enhanced risk-based Part 11 program.

10:40 Networking Refreshment Break, Poster Viewing and Exhibit Hall Opens

11:10 Risk Analysis: How to Use Risk Assessment for 21 CFR Part 11 Compliance
Victoria V. Lander, Market Development Manager, NuGenesis Technologies
You’ve read the final FDA Draft Guidance Document discussing the revised scope and applicability of 21 CFR Part 11 and its risk-based
approach to Part 11 compliance, and yet you still don’t quite know what to do next. What is a Risk Assessment? How is it different from Risk
Management? What do other FDA regulated industries use for Risk Analysis? This seminar will answer these questions and more. The favored
risk assessment protocols from the Food and Medical Device industries such as HACCP, FMEA and FMECA will be addressed, as well as how
you can apply them to 21 CFR Part 11 compliance.

11:40 Computer System Validation and Part 11 Considerations in a Retrofitted Facility

Michael A. Kolba, Senior Director of Validation Operations, Aker Kvaerner Pharmaceuticals
This presentation describes the steps and procedures to follow in assuring existing computer systems in a cGXP retrofit facility meet the
predicate rule requirements for Computer Systems Validation and 21 CFR Part 11 Compliance upgrades. The presentation will focus on an
existing computer system in a cGXP facility that is being retrofitted by the user. We will focus on the steps involved in Computer Validation
Assessment, Part 11 Applicability, and Remediation Approach. This approach could be utilized both on existing or new systems to be
introduced into a retrofitted cGXP environment.

12:10 Networking Lunch in Exhibit Hall

Training Academy Course

Validating Commercial Off-the-Shelf Software for 21 CFR Part 11 Compliance
This course presents a ten-step plan for validating all commercial off-the-shelf (COTS) software used to generate records and maintain data
critical to the development, manufacture and distribution of drug products, medical devices and biologics. Participants will learn the process from
the initial determination of the need for COTS software, vendor selection and qualification, to the completion of a robust validation as well as
what needs documentation and how to prepare it. By taking the mystery out of what inspectors look for and how to prepare for an FDA
inspection, you can utilize efficient techniques for computer system validation that will reduce validation time and save resources.
For more information about this course, visit: www.LifeSciencesInfo.com/2986.
In-House Training Courses
We Bring the Information to You! For More Details, Contact: Judy Freidus at (508)-616-5550 or jfreidus@ibcusa.com.

To Register
Phone: (508) 616-5550 • Fax: (508) 616-5522 • E-Mail: reg@ibcusa.com
1:30 A Capability Maturity Approach to Achieving Compliance Excellence
Kevin C. Martin, Director, Sales & Marketing, CimQuest, Inc. USA
This presentation provides a structured approach to assessing a company’s (or department within a company) level of compliance and
helping them to achieve operational and compliance excellence. By applying a capability maturity assessment model that is tightly coupled
with a risk-based analysis, key compliance elements are identified. This model includes building blocks and uses a stepwise approach for any
company or department to elevate themselves to the next higher level of compliance. Upon achieving the highest maturity level, the company
or department will realize operational excellence and be at the highest level of compliance. This presentation includes an interactive session
where attendees will be provided a scenario and then be challenged to provide a solution. The attendees will learn how to apply a risk based
assessment to several systems in an operating environment.

2:00 Risk-Based Approach to Compliance: Network Infrastructure Qualification

Wolfgang Winter, Senior Product Manager, Agilent Technologies, Germany
According FDA’s risk-based initiative to cGMP compliance and the guidance on 21 CFR Part 11 released in August 2003, your documented
business practices and risk analyses determine FDA enforcement of GxP and part 11. High risk systems require technical controls for access
security, operational/device checks, also appropriate staff training, documentation, and change control. Using real world examples from
analytical laboratories, this presentation discusses why a trustworthy computer network infrastructure is critical for modern data
management software such as chromatography data systems, LIMS, or knowledge management systems and shows how network monitoring
is enabling effective network qualification.

Transitioning to a Paperless System

CASE STUDY
2:30 Design and Implementation of an Electronic Batch and Assay History Record Strategy
Chris Schreil, Senior Manager of Automation Engineering, Projects and Infrastructure, Genentech, Inc.
Abstract not available at press date. For updates visit: www.LifeSciencesInfo.com/Part11.

3:00 Securing Systems for Part 11

Elien Young, E-Compliance Manager, Novartis
Security has always been an important aspect of regulated systems. Health authorities want the integrity of the data assured both through
technology and procedures. Part 11 defines items that must be addressed to assure the data integrity regulatory agencies expect. The risk
based approach helps firms insure that resources are directed towards protecting important assets.

3:30 Networking Refreshment Break, Poster and Exhibit Viewing – Last Opportunity for Exhibit Viewing

4:00 Successful Compliance Strategies in Light of Recent Part 11 and Computer Validation Enforcement
Trends - Auditing for Part 11 Compliance and Quality
Gregory Meyer RAC, CQA, President and Principle Consultant, Compliance Media and acting Director of Compliance,
Connetics Corporation
Strategy for enforcement of Part 11 may have changed and the text of the regulation itself may as well, but common sense and current
regulations still provide clear requirements for quality oversight and compliance auditing of systems required for the manufacture and testing
of regulated medical products. U.S. and E.U. standards for internal and contractor oversight and validation of critical systems will be
discussed and a method for auditing computerized systems of all types will be discussed.

4:30 Developing Strategies to Implement Electronic Record Archiving to Meet Current and Future Regulatory
and Legal Requirements
Charlie Sodano, Ph.D., Manager Information Services, Berlex Biosciences
Almost all research and development data, documents and records today are being authored or generated electronically. However, the archive
media of choice is still paper with a disaster recovery copy as microfilm for most operations. Laboratory and research records need to be
retained somewhere between a few years to greater than 40 years depending on the importance of the information to a company’s business.
As we move more into electronic drug applications, patent submissions and e-business transactions there will be an increased emphasis on
long-term storage of electronic records. Possible strategies will be described that organizations can adapt right now to assure a smooth
transition into electronic record archiving.

5:00 Networking Cocktail Reception in Exhibit Hall

www.LifeSciencesInfo.com/Part11
For detailed abstracts and up-to-date information on this event
Tuesday, February 24, 2004
8:30 Coffee and Breakfast Bakeries

9:00 Chairperson’s Remarks

Massoud Lavian, Senior Consultant and Project Manager, Clarkston Consulting

9:10 Electronic Records and Signatures

Jerry Anderson, Director, Corporate Quality Computer Systems, Watson Pharmaceuticals
In its August 2003 guidance document, FDA indicated that while some elements of Part 11 will now be enforced with discretion, the
electronic signature elements of Part 11 will continue to be fully enforced. The use of electronic signatures can reduce workflow cycle times
and increase productivity, but also introduces new business and compliance risks. Organizations that use or plan to use electronic signatures
should have a clear strategy for mitigating these risks.

Computer and Equipment Validation

9:40 Managing Change in a Validated Environment
Massoud Lavian, Senior Consultant and Project Manager, Clarkston Consulting
In every operation today, change is inevitable. Change is needed to stay up to date with technology advancement, correct previous mistakes,
improve efficiency, or simply to repair equipment. Many companies spend a tremendous amount of time and energy to validate a system and
bring it under control, only to lose that state with the first change in the system. In some companies, Change Management process is so
cumbersome and time-consuming that staff is either avoiding any changes, or by the time change is approved, it is not needed anymore, or it
is outdated. What is a reasonable approach to take advantage of latest advances and still keep the Quality Assurance function satisfied? A
logical approach for designing and implementing a Change Control program in a validated environment is presented and discussed during
this presentation.

10:10 Validation of an Enterprise Resource Planning (ERP) System

George J. Serafin, President, The Serafin Group, LLC
Learn the strategy, and techniques necessary to validate an Enterprise Resource Planning (ERP) system in compliance with 21 CFR Part 11
and current FDA expectations for computer system validation. This presentation will use SAP R/3 as the example ERP system and include
discussions of industry best practices and FDA inspection experiences. Key topics include: Validation Strategy, Key Deliverables, Risk
Assessment, Data Migration, System Acceptance Testing, Security, and FDA Inspection Readiness.

10:40 Networking Refreshment Break, Poster and Last Opportunity to View Exhibits

11:10 Working with Legacy Systems: Can They Be Compliant?

Larry Puderbach, Sr. Director, Part 11 Compliance, Wyeth Pharmaceuticals (invited)
Abstract not available at press date. For updates visit: www.LifeSciencesInfo.com/Part11.

11:40 Managing Computer Systems Related Vendors in a Regulated Environment

Terry L. Stinger, Computer Systems Auditor, Corporate Quality Assurance - Computer Systems, Eli Lilly and Company
In order to comply with FDA regulations and streamline business operations, the pharmaceutical industry has reached out to computer
systems-related vendors by requesting products and services to alleviate their need to develop and maintain proprietary software applications
necessary to sustain cGMP business operations. As a result, the pharmaceutical industry has become more dependent of vendors to develop
and support application software with a higher degree of structural integrity and assurance of proper operation. This presentation will discuss
a process to effectively and efficiently manage computer systems-related vendors by assessing risk, defining an approach to investigate the
vendor’s business practices that pose risk, and from this, determine an appropriate manner by which the vendor may be used to develop and
maintain application software. The “Manner or Use” thus becomes an integral component of the computer system validation process. This
discussion will focus on vendors contracted to develop custom application software as well as vendors providing commercial off-the-shelf
(COTS) packaged software.

12:10 Close of Main Conference

A Guide to Good Validation Practice

By Alex D. Kanarek, Ph.D.
130+ pages, 25+ exhibits, including sample forms and checklists
This Guide provides practical advice on compliance with the requirements for the validation of facility systems, manufacturing processes and
analytical test methods.
Don’t let lack of compliance cost you $$$ - Order your copy today at www.drugandmarket.com/9049 or call +1 (508) 616-5566.

For Exhibiting Information

Contact Mike Washkowitz • (508) 614-1439 • mwashkowitz@ibcusa.com
Post-Conference Symposium Tuesday, February 24, 2004
Comparability Protocols for Biologicals: Strategies for Post-Approval Changes

E
stablishing product comparability for biologicals has become an integral part of the manufacturing
process. Proving the efficacy of an end product after a manufacturing change through chemical
comparability is key to avoiding costly clinical trials. This workshop will expose attendees to the latest
developments in comparability, including:

• U.S. and European regulatory policies for demonstrating comparability

• Meeting FDA expectations for demonstrating comparability
• Immunogenicity issues faced in comparability
• A Genentech case study on effectively demonstrating product comparability
• A special roundtable discussion on the pathway being established for the approval of generic biotech products

1:00 Workshop Registration

2:00 Chairperson’s Opening Remarks

Jeanne Novak, Ph.D., President and Principal Consultant, CBR International

2:05 Navigating U.S. Policies Effecting Comparability

Jeanne Novak, Ph.D.

2:35 Europe: Review of the European Approach to Comparability

Dianne Jackson-Matthews, Ph.D., Director of Regulatory Affairs, ERA Consulting Group

3:05 Meeting FDA Expectations for Comparability

Andrea Loewen-Rodriguez, Ph.D., Associate Director, Regulatory Affairs, IDEC Pharmaceuticals

3:35 Networking Refreshment Break

3:55 Immunogenicity Issues in Demonstrating Comparability

Steve Swanson, Ph.D., Director of Clinical Immunology, Amgen, Inc.

CASE STUDY
4:25 Post-Approval Changes: A Necessary Evil in the Product Lifecycle
Rhona O’Leary, Ph.D., Senior Scientist, Recovery Sciences, Genentech, Inc.

4:55 Roundtable Discussion: Establishing a Regulatory Pathway for the Approval of Biogenerics
Generic biotechnology products represent a large potential market for the biopharmaceutical industry. Current regulatory positions on
comparability may hold implications for the development and approval of generics, as there is no real regulatory pathway in place for the
approval of these biologics. This discussion will focus on hurdles in the approval process for biogenerics, how chemical comparability may
be used and what role clinical trials will play in the approval process.
Moderator: Gail Sofer, M.S., Director of Regulatory Services, BioReliance
James Green, Ph.D., Vice President of Pre-Clinical and Clinical Development, Biogen, Inc.
Kenneth Hughes, Ph.D., Vice President of Scientific Affairs, Microbix Biosystems, Inc.
Steven Bende, Ph.D., Vice President, Science and Regulatory Affairs, Generic Pharmaceutical Association (invited)

5:30 Close of Symposium

www.LifeSciencesInfo.com/Part11
For detailed abstracts and up-to-date information on this event
 Marketing Opportunities at 21 CFR Part 11
Take advantage of the sponsorship and exhibiting opportunities that are available at this year’s 21 CFR Part 11 event to raise the profile of your
company’s image, products and services to your potential customers and future partners.
This event represents a cost-effective and efficient way to tap into a highly targeted group of executives prepared to make buying and
collaborative decisions. Booth space for this event is limited.
Join our early confirmed exhibitors: BioProcess International • BioReliance • MDS Pharma • Pall Life Sciences
Sponsorship Opportunities Include: Cocktail Reception, Breakfasts, Luncheons, Refreshment Breaks, and Tote Bags. For information
about available sponsorship and exhibiting opportunities, contact: Mike Washkowitz, Senior Account Executive, at 508-614-1439.
Fax: 508-616-7950. Email: mwashkowitz@ibcusa.com.

Present a Poster at the Conference

POSTERS: Space is available for posters. Researchers with new results/data in areas relevant to the subject matter of the conference are
encouraged to submit Abstracts for poster presentations to ensure the broadest possible coverage and exchange of recent advances.
Deadline for proposed title and a one-page Abstract is February 2, 2004 for inclusion in the conference handbook. Please complete the
registration form and return with the Abstract or complete Abstract title. (Please be sure to include complete Abstract title and contact
information on the Abstract). Size of conference poster board: 4'h x 8'w. Please note: Poster submission fee is: $50. Payment of conference
registration and poster fees by February 2, 2004 is required for inclusion in the conference handbook and for poster board assignment.

About IBC’s Biopharmaceutical Production Series

IBC Life Sciences actively researches the advancements, technologies and trends impacting and driving the race to
develop and improve the complex processes needed to produce biologics. No other organization can make claim to
the breadth and quality that IBC Life Sciences delivers in each event. Take a look at our select listing of conferences
and see why IBC is recognized around the globe for quality, service and value.

Upcoming Conferences
Well Characterized Biologicals EuroTIDES: Oligonucleotides and Peptides
November 12-14, 2003 • Vienna, VA November 10-13, 2003 • Munich, Germany
The Impact of Post-Translational & Chemical Modifications Cell Culture and Upstream Processing
on Protein Therapeutics December 8-10, 2003 • San Diego, CA
November 12-14, 2003 • Vienna, VA
Antibody Production & Downstream Processing
October 27-29, 2003 • Basel, Switzerland
For more information on U.S. events: www.LifeSciencesInfo.com For more information on European events: www.ibc-lifesci.com

Venue and Registration Details

Sheraton San Diego Hotel & Marina
1380 Harbor Island Drive • San Diego, CA 92101-1092
Tel: (619) 291-2900 • Fax: (619) 692-2337 • Web Site: www.sheraton.com/sandiegomarina
DISCOUNT ACCOMMODATIONS AND TRAVEL: IBC has allocated a block of rooms at a special reduced rate. Be sure to mention IBC when contacting the hotel directly before
January 29, 2004. Please contact IBC if you require assistance.
SUBSTITUTIONS/CANCELLATIONS: In order to receive a prompt refund, your notice of cancellation must be received in writing (by letter or fax) 10 working days before the conference. We
regret cancellations will not be accepted after that date. However, we will be pleased to transfer your registration to another member of your company at any time. If you plan to send someone in
your place, please notify us as soon as possible so that materials can be prepared. All cancellations will be subject to a $195 processing fee. If IBC cancels an event, IBC is not responsible for
any airfare, hotel or other costs incurred by registrants. Speakers subject to change without notice.
SPECIAL NEEDS: If you have a handicap or have dietary needs, please let us know in order that we may address your special needs for your attendance at this conference.

For Exhibiting Information

Contact Mike Washkowitz • (508) 614-1439 • mwashkowitz@ibcusa.com
 IBC’s Inaugural Conference on

21 CFR Part 11
Ensuring Compliance to Prevent Citations and
Manufacturing Interruptions
February 23-24, 2004
Sheraton San Diego Hotel & Marina
San Diego, CA

www.LifeSciencesInfo.com/Part11

21 CFR Part 11 Registration Form Product Code: 3005 FAX How to Register
Online: www.LifeSciencesInfo.com/Part11
First Name Last Name Phone: (508) 616-5550
Fax: (508) 616-5522
Title E-mail
E-mail: reg@ibcusa.com
Company Department
Team Discount – Register 3, the 4th goes FREE!
Street Address When three members of the same company register for the conference at the same
time, the fourth attends for FREE! Complete registration forms for all parties must be
City State Zip Country sent together with complete payments for the entire group to qualify for team discounts.
No partial payments or registrations sent without payment are eligible for this discount.
Telephone Fax

Registration Fees Commercial Govt./Acad.* Payment (required in advance of the conference)

Main Conference + Post-Conference Symposium ❏ $1449 ❏ $699 ❒ Mastercard ❒ Visa ❒ American Express
Main Conference ❏ $1299 ❏ $599
❒ Check ❒ Wire Transfer

Antibody Production Whole Conference Special Reduced Save $300! Save $200! Please make check(s) (in U.S. funds drawn on a U.S. bank) payable to IBC USA
Rate for 21 CFR Part 11 Attendees ❏ $1199 ❏ $599 Conferences and attach to the registration form. Confirmation of your booking will be
Antibody Production Pre-Conference Symposium
sent. Wire Transfer: Please tell your bank to include the conference code 3005, invoice
on Regulary Environment (Wed. a.m.) ❏ $250 ❏ $99 number, person attending, name and date of the conference in the transfer instructions.
Transfers should be made to Fleet Bank NA, 1185 Ave. of the Americas, 3rd Fl., New
To Reserve a Posterboard** ❏ $50 ❏ $50
York, N.Y. 10036. Account No. 9417201626, Routing No. 021200339.
*Academic rate is extended to full-time employees of government,
universities & university-affiliated hospitals only.
**Payment by February 2, 2004 is required for posterboard assignment Total:
CARD # EXP. DATE
For security precautions, a photo identification will be required of ALL attendees at check-in.
For on-site registration, please add $100 to the total fee. Prices include lunch, refreshments and speaker documentation.
Unable to Attend? Purchase the Conference Papers NAME (AS APPEARS ON CARD)
This comprehensive selection of bound “hot off the press” information will be available two weeks after the conference.
❒ I cannot attend. Please send ______ Main Conference Handbook(s). Enclosed is my payment for $399 each, plus shipping and
handling ($25 in the U.S., $45 outside the U.S.).
SIGNATURE

DATA PROTECTION: The personal information shown on this brochure, and/or provided by you, will be held on a database and may be shared with companies in the Informa Group. Sometimes your details
may be obtained from, or made available to, external companies for marketing purposes. If you do not wish for your details to be used for this purpose, please email data-admin@ibcusa.com