21 CFR Part 11 Week: Strategies for Clinical Compliance

Venue: Hyatt Regency

Location: New Orleans, Louisiana, United States

Event Date/Time: Oct 22, 2002 End Date/Time: Oct 25, 2002
Registration Date: Oct 22, 2002
Early Registration Date: Aug 02, 2002
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Description

No need to search, worry or wonder how to solve your toughest Part 11 clinical compliance problems. Here’s an outstanding conference that goes point-by-point over proven, tested and perfected solutions to pressing issues every clinical professional faces.
Get dozens of tried-and-true concepts, approaches and techniques that are being used effectively in organizations – just like yours - that are faced with the daunting task of complying with Part 11. Not only will you hear industry experts but you will hear from 6 case studies from professionals just like you.
When you attend this Executive Conference you won’t stop learning for a minute. You’ll learn how to anticipate what components of Part 11 the FDA is going to focus on in the coming months . . . how to perform a compliance assessment and how validate your clinical systems to ensure compliance.
None of us has the time for expensive, time-consuming trial-and-error learning. That’s why IQPC has assembled an unparalleled faculty of leading experts who have helped organizations master GCP requirements and ensure Part 11 clinical compliance.

Act Now. Register Yourself and a Team of Key People Today!
#1 Best Selling Pharmaceutical Conference

Hear industry experts share key strategies and detailed lessons on:
· Understanding the regulatory requirements of 21 CFR part 11 and its implications on your organization
· Undertaking a 21 CFR Part 11 compliance assessment
· Developing a customized approach to Part 11 compliance
· Auditing software vendors for compliance with 21 CFR Part 11
· 21 CFR Part 11 computer systems validation requirements: no longer the stealth regulation
· Real life auditing experiences
· Complying with electronic archiving requirements
· Navigating the audit trail – practical lessons for compliance with 21 CFR Part 11
· Evaluating system information against Part 11 requirements
· Complying with global regulatory requirements without breaking the bank
· Understanding HIPAA’s role in Part 11 compliance
· Developing IT training roadmaps to deal with the implications of Part 11

Attention Professional Association Members!

If you are a member of a qualified professional organization please call our Registration Center immediately! You may be entitled to extra discounts based on your professional membership. Please call 800-882-8684 for full discount information.

Hear from the industy’s leading experts including:
Martin Browning
Former FDA Investigator
Eduquest

Joseph Noferi, Esq.
PHARMACIA GLOBAL SUPPLY API,

S. Albert Edwards
TAP PHARMACEUTICAL PRODUCTS, INC.

Michael Rutherford
ELI LILLY & COMPANY

Bryan Wade
ELI LILLY & COMPANY

S. Albert Edwards
TAP PHARMACEUTICAL PRODUCTS, INC.

Lic. Johnnie Guerra
Former FDA Instrument and Computer Specialist
GUERRA CONSULTING GROUP

Philip Lord
THE DIGITAL ARCHIVING CONSULTANCY

Tuan Phan
VALIDATION ASSOCIATES

Valarie King-Bailey
QUMAS

Bryan Raybuck
BAXTER HEALTHCARE

Michael Chace-Ortiz
PA CONSULTING

Lisa Olson
SEC ASSOCIATES

Robert Rhorer
COHEGUN CONSULTING

Lowrie Beacham
DUKE CLINICAL RESEARCH INSTITUTE

Lisa Ensign
NETREGULUS

Kevin Martin
CIMQUEST

IF YOU ATTEND ONLY ONE CONFERENCE THIS YEAR MAKE SURE IT’S IQPC’S 21 CFR PART 11 CLINICAL COMPLIANCE STRATEGIES.
HERE’S WHY…
1 This is the only Part 11 conference on the market focusing exclusively on GCP requirements and clinical compliance strategies. No other event on the market will arm you with information geared exclusively to complying with the FDA’s requirements for clinical trials and drug discovery.
2 Superb networking opportunities. Where else can you exchange ideas on Part 11 with so many of your peers – all of whom are struggling with the same clinical compliance issues that you are. Your fellow conference attendees are all senior executives and top decision makers at the world’s leading pharmaceutical, medical device, biotech and CRO organizations. We’re expecting a full house – so bring plenty of business cards!
3 The registration fee is a mere fraction of the “market” cost of the information you will receive. When you attend IQPC’s 21 CFR Part 11 Clinical Compliance Strategies conference you will hear over 15 hours of detailed information, (30 hours if you choose to attend the intensive, knowledge-rich workshops) including “how-to” strategies, checklists and methodologies that will help your organization chart its course for complete Part 11 compliance. Conservative estimates of bringing these experts in-house for three days of intensive training would be $10,000. By attending IQPC’s Executive Conference you can save as much as $6,200!

During This Executive Conference You Will Learn How To:
· Understand the regulatory requirements of 21 CFR Part 11 and its implications on your organization
· Undertake a 21 CFR 11 compliance assessment
· Develop a customized approach to Part 11 compliance based on specific company needs
· Conduct a gap analysis to identify areas in need of remediation
· Develop remediation planning
· Create a sound compliance methodology that encompasses all the major components of Part 11, including audit trails, gap analysis, systems validation and much more
· Efficiently archive clinical data
· Develop gap analysis forms using a structured engineering approach
· Standardize computer systems validation practices across departments
· Implement procedural controls for the audit trail for textual electronic records
· Evaluate the strength of validation packages before and after the sale
· Understand the nuances among GCP, GMP and GLP
· Anticipate which Part 11 components the FDA will focus on next
· Organize your gap analysis strategy
· Apply electronic signature and PKI technologies to Part 11 requirements
· Conduct an effective GCP and quality systems audit
· Monitor clinical trials for GCP compliance
· Plan a step-by-step approach for auditing software vendors and data providers
· Migrate from paper to electronic records
· Implement a Part 11 compliant EDC and management system
· Survive an FDA audit
· Respond to 483s and FDA warning letters

Venue

500 Poydras Plaza
New Orleans
Louisiana
United States
MORE INFO ON THIS VENUE

Additional Information

Register by August 2, 2002, pay in full for the conference plus 2 workshops and receive 2 nights hotel accommodations free compliments of IQPC!