The Legal and Business Forum on

cGMP

for Pharmaceutical, Biotech, and Medical Device Companies

Thursday, June 12, 2003

About

In August of 2002, the FDA announced a new initiative to modernize and revamp its rules on pharmaceutical manufacturing. The initiative, entitled "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach" ("FDA cGMP Initiative" or "initiative"), came as welcome news to an industry hit recently by fines of unprecedented magnitude for manufacturing violations.

While the pharmaceutical industry is hopeful that the initiative will clarify its obligations, there are questions. What will the initiative - the most significant attempt in 25 years to revamp manufacturing rules - entail? Moreover, as the initiative is being shaped, how does industry comply with cGMPs that are presently in place - especially since the FDA has made it clear that it will continue to enforce current regulations?

In the current uncertain climate, it is imperative that counsel and executives responsible for quality affairs and manufacturing at pharmaceutical, biotech or medical device companies have an up-to-the minute and complete understanding of not only the developing FDA cGMP initiative, but also how to stay in compliance and stay out of trouble under the status quo.

This American Conference Institute forum had been developed to bring you the latest information and valuable insights from those making and influencing the future of cGMP regulation and enforcement. Peter Barton Hutt, I. Scott Bass and William W. Vodra, top authorities in this area, lead an outstanding faculty of leading attorneys, quality control executives and consultants, and key FDA representatives who are shaping the initiative and monitoring enforcement. They brought thoughtful and targeted commentary on:

  • The evolution of the cGMP program - from its inception to its future - as envisioned by the FDA cGMP Initiative
  • Implementing an effective cGMP compliance program
  • What you should - and should not do during an FDA inspection
  • How to cut the best deal for your company if a violation is found
  • Bypassing a consent decree and avoiding a settlement: what are the other options?
  • Living with the repercussions of a consent decree when there is no other option
  • How to brace your company for the litigation fallout that sometimes accompanies cGMP problems
  • Special cGMP concerns for the makers of biologics and third party manufacturers
The stakes of non-compliance - consent decrees, fines, delayed approvals - are high and getting higher all the time. Take this valuable opportunity to hear from those at center stage how to reduce your risks and what to expect over the next few years.

Contents & Contributors

About

In August of 2002, the FDA announced a new initiative to modernize and revamp its rules on pharmaceutical manufacturing. The initiative, entitled "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach" ("FDA cGMP Initiative" or "initiative"), came as welcome news to an industry hit recently by fines of unprecedented magnitude for manufacturing violations.

While the pharmaceutical industry is hopeful that the initiative will clarify its obligations, there are questions. What will the initiative - the most significant attempt in 25 years to revamp manufacturing rules - entail? Moreover, as the initiative is being shaped, how does industry comply with cGMPs that are presently in place - especially since the FDA has made it clear that it will continue to enforce current regulations?

In the current uncertain climate, it is imperative that counsel and executives responsible for quality affairs and manufacturing at pharmaceutical, biotech or medical device companies have an up-to-the minute and complete understanding of not only the developing FDA cGMP initiative, but also how to stay in compliance and stay out of trouble under the status quo.

This American Conference Institute forum had been developed to bring you the latest information and valuable insights from those making and influencing the future of cGMP regulation and enforcement. Peter Barton Hutt, I. Scott Bass and William W. Vodra, top authorities in this area, lead an outstanding faculty of leading attorneys, quality control executives and consultants, and key FDA representatives who are shaping the initiative and monitoring enforcement. They brought thoughtful and targeted commentary on:

  • The evolution of the cGMP program - from its inception to its future - as envisioned by the FDA cGMP Initiative
  • Implementing an effective cGMP compliance program
  • What you should - and should not do during an FDA inspection
  • How to cut the best deal for your company if a violation is found
  • Bypassing a consent decree and avoiding a settlement: what are the other options?
  • Living with the repercussions of a consent decree when there is no other option
  • How to brace your company for the litigation fallout that sometimes accompanies cGMP problems
  • Special cGMP concerns for the makers of biologics and third party manufacturers
The stakes of non-compliance - consent decrees, fines, delayed approvals - are high and getting higher all the time. Take this valuable opportunity to hear from those at center stage how to reduce your risks and what to expect over the next few years.

Contents & Contributors

AN OVERVIEW OF CGMP'S FOR THE 21ST CENTURY
Steven M. Niedelman, Office of Regulatory Affairs

RISK MANAGEMENT AND FDA'S "PHARMACEUTICAL CGMPS FOR THE 21ST CENTURY" INITIATIVE
David J. Horowitz, Center for Drug Evaluation and Research

AN OVERVIEW OF FDA'S DRAFT GUIDANCE FOR INDUSTRY ON PART 11: ELECTRONIC RECORDS & ELECTRONIC SIGNATURES
Joseph C. Famulare, Center for Drug Evaluation and Research

THE PAT INITIATIVE
Albinus D'Sa, Ph.D., Center for Drug Evaluation and Research

THE FDA CGMP INITIATIVE: REACTIONS AND RESPONSES
Scott Lassman, PhRMA

CGMP: AN INDUSTRY PERSPECTIVE
William J. Kennedy, Ph.D., Pharmaceutical Consultant

CONSENT DECREES
Barry A. Berger, GlaxoSmithKline

IMPLEMENTING AN EFFECTIVE CGMP COMPLIANCE PROGRAM
Christopher G. Allen, Bayer Consumer Care North American Division

MANAGING GLOBAL QUALITY AND COMPLIANCE
Gerry P. Migliaccio, Pfizer Inc.

HANDLING AN FDA INSPECTION: WHAT YOU NEED TO KNOW
Peter O. Safir, Covington & Burling

CURRENT GOOD MANUFACTURING PRACTICES
Edward John Allera, Buchanan Ingersoll, PC

WHAT DO YOU DO IF A VIOLATION IS FOUND? WHEN TO FIGHT, WHEN TO FOLD
Tony Celeste, AAC Consulting Group, Inc.

RESPONDING TO THE FDA 483
Ronald F. Tetzlaff, Ph.D., KMI/PAREXEL, LLC

IF A VIOLATION IS FOUND - TO FIGHT OR FOLD
Richard O. Wood, Bell, Boyd & Lloyd L.L.C.

LIFE AFTER A CONSENT DECREE: A LAWYER'S PERSPECTIVE
Douglas Farquhar, Hyman, Phelps & McNamara, PC

LIFE UNDER A CONSENT DECREE
Edward Kaminski, Ph.D., Wyeth

CONSULTANT ACTIVITIES IN CONSENT DECREES EXPERIENCE AND HIGHLIGHTS
R. Owen Richards, Quantic Regulatory Services
Claudio Pincus, The Quantic Group

HOW TO AVOID A SETTLEMENT WITH THE FDA OR CAN YOU REALLY AVOID A CONSENT DECREE?
Ronald Johnson, Quintiles Consulting

HOW TO LITIGATE AN FDA CGMP CASE IN COURT
Charles Raubicheck, Frommer Lawrence & Haug LLP

POSSIBLE COMMERCIAL LITIGATION ISSUES FOR VIOLATING CGMPS IN THE PHARMACEUTICAL AND MEDICAL DEVICE INDUSTRY
Alice S. Johnston, Buchanan Ingersoll, P.C.
Michael J. Cetra, Buchanan Ingersoll, P.C.

GMP STANDARDS FOR BIOLOGICS AND BIOTECH
Robert P. Brady, Hogan & Hartson

GMPS IN THE 21ST CENTURY: MEETING CUSTOMERS EXPECTIONS
Joseph C. White, Ph.D., Cardinal Health Pharmaceutical Technology and Services

THIRD PARTY MANUFACTURING
Efrem H. Zaret, Ph.D., EZ Assosicates


DOCUMENT TYPES: PRESENTATIONS AVAILABLE: 0