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.
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
Publication Details