Practical Preparation for Effective GMP Training
Six Steps to Success!
First published in the Journal of GXP Compliance, this
article is the first of three parts aimed at developing an
effective GMP training process.
Conducting Effective GMP Training:
Do’s and Don’ts for Success!
First published in the Journal of GXP Compliance, this is the
second of three parts.
Effective Follow-up Strategies
to GMP Training
First published in the Journal of GXP Compliance, this is the final of
three parts.
A Risk-based Approach to GXP Training:
One Size Does Not Fit All
First published in the Journal of GXP Compliance, this
article explores developing an effective GMP training
process in sync with FDA's new risk-based approach.
A System of Leadership for the 21st Century
Lessons from Theodore Roosevelt
An unique perspective building on David's innovative approach of
bringing Teddy Roosevelt Back to Life.
Problem
Solving is Not Good Enough! Problem Prevention is the Key to
Success Effective use of After Action Reviews.
Personal Productivity
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100 Ways to
Kill a Concept: Why Most Ideas Get Shot Down - This short
e-book will help you become better at "selling" your ideas and creating
a culture of innovation in your workgroup.
Innovation: More Than a
New Year's Resolution - This short e-book will help you defy
complacency in your work and career.
The Six Core Values of
Innovation - This short e-book describes the six core values, or
contexts, of innovation.
A Major Mistake That
Managers Make - Article by Russ Ackoff, Ph.D.
A Little Book of
f-Laws: 13 common sins of management - Article by Russ Ackoff, Ph.D.
Transforming the Systems
Movement - Article by Russ Ackoff, Ph.D.
From Mechanistic to
Social Systems Thinking - Article by Russ Ackoff, Ph.D.
Questionating - This short e-book
will help you develop your skill in asking questions. It was W. Edwards
Deming who said, "The questions are more important than the answers."
Nelson Mandela's Lessons of Leadership
- Excellent article from Time
FDA Resources
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Innovation
or Stagnation - Important report issued by FDA in March 2004, and
revised and updated in 2005.
FDA Recall Data
for FY 2005 - CDER recalls in FY 2005, Top Ten reasons
Centennial of the
1906 Pure Food and Drugs Act - First in a series of articles
in 2006 that will highlight some of the popular perceptions of the 1906
Pure Food and Drugs Act
Dispute Resolution Guidance - Formal Dispute Resolution: Scientific
and Technical Issues Related to Pharmaceutical cGMP Guidance Document
issued January 11, 2006
FDA
Enforcement Report February 1, 2006 - A sample of FDA's weekly
Enforcement Report
The
Regulation of Dietary Supplements - Congressional testimony by the
FDA Director of the Center for Food Safety and Applied Nutrition on
March 9, 2006
FDA's
Deputy Commissioner Speech, March 14, 2006 - Scott Gottlieb, MD,
FDA's Deputy Commissioner for Medical and Scientific Affairs address at
the 30th International Good Manufacturing Practices Conference at the
University of Georgia College of Pharmacy
Human Drug CGMP Notes
March 1999 - FDA's reference to Process Validation and "three
consecutive batches"
Small Business
Guide to FDA - FDA's handbook for small business. Contains
information about FDA's organization, procedures, policies, and
regulations.
FDA
Enforcement Report Aug 9,2006 - Selected excerpts from FDA's
Enforcement Report highlighting GMP issues.
Current Good Tissues Practice
Guidance Document - FDA Guidance for Industry issued September 2006.
Current Good Tissue Practice Regulation
- FDA's regulation implemented in 2005.
Implementing Quality
Systems - PowerPoint presentation by Chris Joneckis, PhD FDA
CBER August 2006
Quality Systems Approach to
Pharmaceutical cGMP Regulations - Guidance document issued September
29, 2006.
OOS Guidance Document - FDA
Guidance for Industry issued October 12, 2006.
FDA presentation on ICH Q10
- Presentation by FDA on ICH Q10 - Quality Systems
FDA Consumer Safety Office
job description - Read the job description for an FDA Investigator
(Consumer Safety Officer).
ICH Q10 Pharmaceutical Quality System
guidance document, July 13, 2007 - Read this new guidance document
available for public comment.
A Parent's Guide to Kids'
Vaccines July 31, 2007 - FDA Consumer Health Information article
FDA Report - FDA Science and
Mission at Risk November 2007 - Read this disturbing report commissioned by the
FDA.
Food Safety Tips for Healthy
Holidays - FDA's Tips for Healthy Holidays
Speech by FDA
Commissioner Feb 29, 2008 - Read this speech entitled "FDA at a
Turning Point: Meeting the Challenge of a Rapidly Changing World" by
Andrew C. von Eschenbach, M.D.
Laws Enforced by the FDA and Related
Statutes - A listing of all the laws and statutes that the FDA
enforces
FDA Manuals, Regulatory Publications,
and Reports - A listing of all the FDA Manuals, Regulatory
Publications, and Reports
Timely Resource
Articles
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Continuous Improvement
under Modern Quality Systems and cGMPs - FDA's Richard Friedman's
presentation at the 2005 Drug Information Association meeting, June 26 -
30 Washington DC
Able Labs in USA Today July 12,
2005 - Read this interesting story published in USA Today.
Able Laboratories FDA 483 July 2005 -
Read this fifteen page FDA 483 with twelve major observations.
Pharmakon Labs Shut
Down July 27, 2005 - Read FDA's Press Release
Jury Award in Vioxx
Trial - August 18, 2005 - First jury award against Merck
US Marshals seize
infusion pumps, Oct 12, 2005 - FDA and US District Court work
together to seize products manufactured by Baxter Healthcare Corp.
FDA Issues
Consent Decree to MBI Nov 29, 2005 - Read FDA's Press Release
Google's Ten Golden Rules Dec 2, 2005 - Newsweek article describing
how Google manages "knowledge workers"
Guidant Corp. FDA 483
Sept 2005 - Read this seven page FDA 483 with fifteen major
observations
Guidant
Corp. Warning Letter Dec 2005 - Read FDA's Warning Letter as a
follow-up to the Sept 2005 FDA 483
Schering-Plough's Consent Decree - Read this 46 page Consent Decree
issued in May 2002 to Schering-Plough Corporation
FDA Cease
Manufacturing Letter Jan 31, 2006 - FDA's letter to Biomedical
Tissue Services Ltd
Executives convicted
May 3, 2006 - FDA's Press Release with details
Centennial of The
Jungle - Read this fascinating story published on May 31, 2006 about
the intricacies of how the landmark book, The Jungle by Upton Sinclair,
led to the Pure Food and Drugs Act of 1906.
Protecting
America's Health - Read this review of Philip J. Hilts' book,
Protecting America's Health: The FDA, Business, and One Hundred Years of
Regulation.
How Theodore
Roosevelt Made Your Dinner Safe to Eat - Read this
fascinating article published in American Heritage Magazine on June 29,
2006
Prescription for Harm: The Decline in FDA's Enforcement Activity -
Congressional report issued June 27, 2006 by Rep. Henry Waxman
Rep.
Waxman's statement June 27, 2006 - Statement upon release of
Prescription for Harm report
Sanofi Pasteur
FDA 483 April 2006 - Read this eight page FDA 483.
Sanofi
Pasteur Warning Letter June 30, 2006 - Read this seven page Warning
Letter.
FDA Q&A regarding
Sanofi Pasteur Warning Letter - Gain valuable insights into FDA's
thinking by reading this Question and Answer document released by FDA on
July 3, 2006
FDA
Commissioner Nomination Embroiled in Politics - Read this article
published the day after the Senate held confirmation hearings on Andrew
von Eschenbach's nomination as FDA's Commissioner.
Command
Medical Products Warning Letter August 17, 2006 - Read this short
Warning Letter and gain insights into FDA's thinking.
American Red Cross fined
by FDA September 8, 2006 - Read this Press Release from FDA
explaining why the American Red Cross was fined $4.2 million for
violating GMP regulations.
USA Today Sept 12, 2006 -
Dr. Graham Speaks Out - Read this article where FDA official Dr.
David J. Graham speaks out about new arthritis drugs.
Graham's editorial published by
JAMA - Dr. David J. Graham's editorial published by the Journal of
the American Medical Association.
GSK recalls Paxil - Missing Active
Ingredient - October 5, 2006 news article
FDA Newsletter from
November 1962 - Historic photos of President Kennedy upon the advent
of GMP
Bausch and Lomb FDA
483 May 2006 - Read this eleven page FDA 483. Bausch and Lomb
issued a recall of one of their products the day after receiving this
483.
Bausch and Lomb Warning
Letter Oct 31, 2006 - Read this eleven page Warning Letter outlining
systemic violations
Perrigo recalls acetominophen Nov 9,
2006 - News story detailing recall of 11 million containers of acetominophen for metal fragments
FDA Press Release - Medical
Device Post Market Monitoring - Nov 9, 2006 - FDA's
action
plan for strengthening the way it monitors the safety of medical devices
after they reach the marketplace.
Boston
Globe news article - Read this analysis of the impact of the
November election and FDA as well as an analysis of FDA's action plan
for Medical Device Post Market Monitoring
Why Drug Prices
are High - An informative article by syndicated columnist Jay
Ambrose published December 11, 2006.
New Congress to Split FDA?
- Published January 7, 2007. An article speculating that the new
Democrat controlled Congress will split FDA into two agencies, one for
the Foods industry, and one for the Medical industries.
GE OEC Medical Systems Consent
Decree announcement - Read FDA's Press Release January 12, 2007
announcing this Consent Decree.
GE OEC Medical Systems Warning
Letter - Read this Warning Letter issued in March 2005.
News account of GE OEC Medical Systems
problems - Read this newspaper account about the problems facing
this company.
The Birth of CGMPs - Read this
article by FDA Historian Dr. Suzanne White Junod about the beginnings of
the CGMP regulation.
Whistleblowers Help Congress
Strengthen FDA - Read this February 2007 article.
FDA's announcement of
Cardinal Health Consent Decree - Read FDA's reasons for obtaining
this consent decree for condemnation and permanent injunction against
Cardinal Health.
Cardinal Health
Consent Decree - Read this 27-page Consent Decree for condemnation
and permanent injunction.
Edwards Life Sciences
Warning Letter - Read this eight page Warning Letter issued in
February 2007
Actavis Totowa, LLC Warning Letter -
Issued February 2007
GE Healthcare Technologies Warning Letter
- Issued February 2007
First Check Diagnostics, LLC Warning
Letter - Issued February 2007
Fisher and Paykel Healthcare Inc. Warning
Letter - Issued February 2007
Medical Concepts Development Warning
Letter - Issued February 2007
Niagara Pharmaceuticals Inc. Warning
Letter - Issued February 2007
Rymed Technologies Inc. Warning Letter
- Issued February 2007
Abbott Consent Decree -
Read this landmark twenty-four page Consent Decree issued in 1999
Abbott
Laboratories, Inc. Warning Letter - Issued to Abbott Diagnostics
Division in March 2007
FDA Comes Under Fire -
AGAIN! - Read this story from the Washington Post April 2007
Senate debates
bill to increase power and money for FDA - Read this story from The
New York Times May 2007
FDA Plans to Close Labs -
Read this story from McClatchy Newspapers on this controversial plan by
FDA to close and consolidate their laboratories May 2007
Advanced Medical
Optics recall notice November 21, 2006 - Read this recall notice of
a contact lens solution - contaminated batches
Advanced Medical Optics Recall of
Contact Lens Solution May 25, 2007 - Read FDA's announcement of
Advanced Medical Optics' recall of one of their contact lens solutions.
Chinese toothpaste advisory June
1, 2007 - Read FDA's advisory to avoid toothpaste containing
diethylene glycol made in China.
Taste of
Raspberries, Taste of Death - Read this chilling account of the 1937
Elixir of Sulfanilamide tragedy
Crystal
Reflections International Warning Letter June 14, 2007 - Read this
Warning Letter issued to a manufacturer of contact lenses. The change
control system consisted of "post-it" notes!
Imported
Generic Drugs on the Rise June 17, 2007 - Read this Washington Post
story about the increase in generic drugs from India and China and FDA's
challenge in inspecting plants in these two countries.
Shelhigh
Consent Decree June 22, 2007 - Read FDA's Press Release announcing this consent decree for a
manufacturer of heart valves.
Chinese FDA
Chief executed July 10, 2007 - Read this startling article on
China's former head of their FDA executed for taking bribes.
AIDS drug
recalled July 23, 2007 - Read this article from the New York Times
detailing the impact on poor people in developing nations of this
contaminated AIDS drug.
Sunburst
Biorganics Warning Letter August 7, 2007 - Read this Warning Letter
to a New York company detailing the fine line between a Dietary
Supplement and a Drug.
Swanson Health Products Inc.
Warning Letter August 8, 2007 - Read this Warning
Letter to a North Dakota company detailing the fine line between a
Dietary Supplement and a Drug.
Proctor &
Gamble Warning Letter September 14, 2007 - Read this Warning Letter
detailing the difference between a sanitizer and a drug.
Contaminated beef
leads to company shutdown October 5, 2007 - Beef processor forced to
recall one year's production and calls it quits
Tylenol is
Different ad campaign - Look at Tylenol's new advertising campaign
"Tylenol is different because of the people who make it."
Med-South Pharmacy
Inc. Warning Letter - An interesting look at drugs compounded by
local pharmacies. Read FDA's comments on how these drugs are regulated.
This is a good case study demonstrating the "c" in cGMP - keeping
current with the ever evolving GMP regulation.
FDA Damned If It
Does, Damned If It Doesn't - An interesting article published in
Fortune about FDA's current strategies.
China Gets Serious
on GMP - China's State FDA is ramping up its enforcement of
GMP, working with US FDA on safety pact.
Dirty Tank
Leads to Contaminated Products - Read this news account of an API
manufacturer who hadn't cleaned a holding tank with a key starting raw
material in years, and how it led to several batches of product getting
contaminated.
G. Dundas and Company,
Inc. Warning Letter December 13, 2007 - Read this Warning Letter
issued because of an inadequate response to a Form FDA 483, List
of Inspectional Observations.
Noven Pharmaceuticals, Inc. Warning Letter
January 4, 2008 -
Read this Warning Letter issued because of an
inadequate response to a Form FDA 483, List
of Inspectional Observations.
Recall Notice of Contaminated Syringes
January 18, 2008 - Heparin and Saline pre-filled flushes recalled
due to bacterial contamination.
Vintage Pharmaceuticals, LLC Warning
Letter February 1, 2008 - Read this Warning Letter issued
because of an inadequate response to a Form FDA 483, List
of Inspectional Observations.
FDA Fines Red Cross $4.6M
February 7, 2008 - FDA assesses another fine on the American Red
Cross for distribution of unsuitable blood products. Fines in recent
years now total more than $19 million.
Red Cross announcement of fine -
February 7, 2008 - Read The Red Cross' announcement regarding the
new fine.
Congressman Calls for FDA Commissioner to
Resign Feb 15, 2008 - Read this news account about FDA getting blamed by a
Congressman for recent problems.
FDA Mixed-up Drug Plant Names in
China Feb 19, 2008 - Read this news article about FDA's mix-up and
Baxter's troubles with heparin, a blood thinner.
Baxter's explanation of the heparin incident
Feb 19, 2008 - Read Baxter's explanation about the heparin incident.
Testimony of Sidney Wolfe, M.D.
before Congress February 27, 2008 - Read Dr. Wolfe's testimony
citing a crisis in leadership in the FDA.
Philips Lifeline, Inc. Warning Letter
February 29, 2008 - Read this Warning Letter issued to a Medical
Device manufacturer
The Heparin Fiasco April 10, 2008 -
Read this New York Times story with details
Trying Times at the FDA: The Challenge
of Ensuring Safety of Imported Pharmaceuticals April 24, 2008 - New
England Journal of Medicine article
National Biological Corp. Warning Letter
April 23, 2008 - Read this Warning Letter dealing with customer
complaint handling and caPA (Corrective and Preventive Action)
Merck Warning Letter April 28, 2008
- Read this nine page Warning Letter issued to Merck and Company, Inc.
Scientific Laboratories Inc. Consent Decree
May 16, 2008
- Read this Press Release from FDA announcing the Consent Decree signed
by Scientific Laboratories Inc.
Warning Letters Drop in Number June 6,
2008 - Read this news report about the Enforcement Shift at FDA
FDA Staff in Crisis - June 8, 2008
- Read this news account of FDA staffers leaving the FDA, where the
average age is 54
Keep your GMP Training ALIVE!
Table Topper example - June 15, 2008 - Here's an example of a Table
Topper you can use in Keeping Your GMP Training Alive
Written Procedures and the Incoming
Workforce - A list of interesting facts regarding those entering the
workforce in 2008. An example: They grew up with digital clocks. Half
past three or quarter to four may have no meaning to them.
cGMP for Dietary Supplements
cGMP for Dietary Supplements
Final Rule June 22, 2007 - FDA's Preamble and Final Rule to the Current Good
Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding
Operations for Dietary Supplements
cGMP for Dietary Supplements 21CFR
Part 111 - Current Good Manufacturing Practice in Manufacturing,
Packaging, Labeling, or Holding Operations for Dietary Supplements
FDA Press Release
announcing cGMP for Dietary Supplements June 22, 2007 - FDA's Press
Release
FDA's Background info on
cGMP for Dietary Supplements June 22, 2007 - FDA's Backgrounder
document
FDA Consumer article on new
Safe Use of Dietary Supplements June 22, 2007 - FDA Consumer Health
Information article
Definition of Adulteration
- Section 402 of the Federal Food, Drug, and Cosmetics Act
NEW!
GMP Training Systems Inc.
announces:
Public workshop set for Nov
12 - 13, 2008 - Click
here for info
cGMP for PET Drugs
On September 19, 2005, FDA proposed cGMPs
for Positron Emission Tomography (PET) Drug Products.
FDA's Press Release - Read FDA's announcement here.
cGMP for PET Drug
Products Guidance Document - Read the Guidance Document here.
FDA's Questions and Answers
- Read FDA's Questions and Answers regarding the proposed cGMPs.
