Professional Documents
Culture Documents
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
9:40 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.
10:40 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.
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.
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.
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
10:40 Networking Refreshment Break, Poster and Last Opportunity to View Exhibits
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:
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)
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.
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
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
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
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